Table of contents
- Latest B. Braun IVC Filter Lawsuit Updates
- July 31, 2024: FDA Issues Decision on VenaTech Filters
- August 9, 2010: FDA Recommends Removing Retrievable Filters
- March 2, 2008: VenaTech LP Recall Is Terminated
- November 24, 2007: FDA Posts Class 2 Recall
- October 30, 2007: B. Braun Starts Removal of a VenaTech LP Lot
- What Is an IVC Filter?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- Can a Laser Sheath Remove a VenaTech IVC Filter?
- What Does the Research Say About IVC Filter Complications?
- How Long Is an IVC Filter Meant to Stay in Place?
- Do Adverse Event Reports Prove an IVC Filter Caused Harm?
B. Braun makes the VenaTech IVC filters. FDA lists filter fracture, migration and perforation of the vena cava among the known long-term risks of IVC filters. Some retrievable filters are never removed once the clot risk passes.
B. Braun has not been named in a multidistrict litigation or a class action. Any claim today would be an individual product liability claim against the maker.
B. Braun’s only FDA recall was a single VenaTech LP lot in 2007, and FDA decided on a VenaTech application in July 2024.
Latest B. Braun IVC Filter Lawsuit Updates
July 31, 2024: FDA Issues Decision on VenaTech Filters
On July 31, 2024, FDA issued its decision on 510(k) K240578 for the VenaTech LP and VenaTech Convertible Vena Cava Filter Systems [1]. B. Braun Medical, Inc. submitted the application, and FDA received it on March 1, 2024.
August 9, 2010: FDA Recommends Removing Retrievable Filters
FDA’s August 9, 2010 communication, as Endovascular Today reported it, recommended that physicians consider removing retrievable IVC filters as soon as protection from pulmonary embolism is no longer needed [2].
The agency said it is concerned that these filters are not always removed once a patient’s risk of pulmonary embolism subsides. The advice applied to retrievable filters as a class, not to one maker.
March 2, 2008: VenaTech LP Recall Is Terminated
FDA’s recall database shows the VenaTech LP recall Z-0264-2008 as terminated on March 2, 2008 [3]. The recall covered one lot of VenaTech LP Vena Cava Filter Systems.
November 24, 2007: FDA Posts Class 2 Recall
On November 24, 2007, FDA posted the Class 2 recall Z-0264-2008 of one lot of VenaTech LP filters. B. Braun had started the removal less than a month earlier.
October 30, 2007: B. Braun Starts Removal of a VenaTech LP Lot
On October 30, 2007, B. Braun initiated the removal of one VenaTech LP Vena Cava Filter lot, 0709240V, because of a package sealing problem.
The sealing problem left the packaging partially open and compromised sterility. The lot held 60 units, and the recall was classed Class 2.
What Is an IVC Filter?
FDA describes an IVC filter as a small cage-like device. It is put in the largest vein in the body to catch blood clots and stop them from traveling to the lungs [4].
Doctors commonly use IVC filters for patients at risk for pulmonary embolism. That is a clot in the lungs. Filters help when blood thinners cannot be used or do not work. Both VenaTech models are filters of this kind.
Who May Be Affected?
Patients implanted with a B. Braun VenaTech LP or VenaTech Convertible filter may be affected. So may anyone with a retrievable IVC filter left in place after the risk of pulmonary embolism passed.
FDA has said that problems have been seen with all retrievable filters, so the concern is not limited to one maker or one model of filter.
Your filter model, the implant date and any complication all shape your situation. Only an individual legal review can say whether you may have a claim. Our IVC filter lawsuit overview covers the wider litigation.
Reported Injuries or Damages
FDA lists these long-term risks of IVC filters: lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization and IVC perforation. Embolization means parts of the device detach.
As of August 2010, FDA had received 921 device adverse event reports on IVC filters since 2005. Of these, 328 were about migration and 146 about embolization. Another 70 were about IVC perforation and 56 about filter fracture.
These counts come from FDA’s August 9, 2010 communication and cover all IVC filter brands, not only B. Braun. They are regulator reports, not claims in a B. Braun complaint.
Recall and Regulatory Background
The 2007 recall went to hospital accounts across the country. B. Braun sent them an Urgent Medical Device Removal letter. The filters were distributed nationwide. A recall does not establish liability.
Evidence to Preserve
Records about the filter and your care can show which device you have and what happened. Keep these items together:
- The filter name, model and lot or serial number from your implant card or hospital record.
- The implant date and the hospital where the filter was placed, with operative and discharge records.
- Imaging that shows the filter, including any fracture, migration or perforation, and records of removal attempts.
- Medical bills and any photographs related to the filter, its removal or a complication.
- Communications with your doctor, the hospital or the manufacturer about the filter.
Filing Deadlines
State law sets the time limit for filing a claim. Your limit depends on where you live and on when your filter injury was diagnosed.
If you miss the filing deadline, your claim may end even when the evidence is strong. Speak with a lawyer promptly about the time limit that applies to you.
Frequently Asked Questions
Can a Laser Sheath Remove a VenaTech IVC Filter?
A laser sheath can remove a VenaTech IVC filter only in limited cases, because FDA says the Philips CavaClear Laser Sheath may not be used to remove a VenaTech IVC filter. The implanting doctor can explain other removal options.
What Does the Research Say About IVC Filter Complications?
The research on IVC filter complications includes an FDA safety communication from 2014, based on reports of adverse events. It recommended that implanting physicians consider removing the filter as soon as blood clots are no longer a risk for the patient.
How Long Is an IVC Filter Meant to Stay in Place?
A retrievable IVC filter is meant to stay in place only briefly. FDA says retrievable filters are intended for short-term placement. The implanting doctor can say whether yours is retrievable.
Do Adverse Event Reports Prove an IVC Filter Caused Harm?
No, reports of adverse events do not prove that a filter caused each event. For some reported deaths, FDA’s device division director was reported as saying it is unknown if filters played a role.