MAUDE Adverse Event Report: B. BRAUN MEDICAL SAS LP VENATECH FILTER

Model Number 31335

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/03/2020

Event Type  Death  

Event Description

On (b)(6) 2020 venatech lp filter was placed for lower extremity dvt and pe with contraindication to anticoagulation.Device was placed from the right internal jugular approach.Filter deployed appropriately and in infrarenal location with expansion of struts.On (b)(6) 2020 a ct scan was performed and ivc filter was seen to have migrated to intrahepatic ivc right atrium.Filter appeared distorted.No central ine placements, cpr, trauma or cardiology procedures were noted.Diameter of the vena cava before implantation: 2.3cm.Filter deployment level: l2, l3.Patient had not undergone any surgery since the filter placement.Patient co-morbidities: pancreatic cancer.There were no patient symptoms prior to the ct scan.Patient passed away of acute kidney renal failure.

• Brand Name: LP VENATECH FILTER
• Type of Device: VENATECH FILTER
• Manufacturer (Section D): B. BRAUN MEDICAL SAS; 26 rue armengaud; 92210 ; FR 92210
• MDR Report Key: 10020722
• MDR Text Key: 189726698
• Report Number: 3006332832-2020-00003
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31335
• Device Catalogue Number: 5010024
• Device Lot Number: 36947576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2020
• Distributor Facility Aware Date: 04/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening