MAUDE Adverse Event Report: B.BRAUN MEDICAL SAS VENATECH LP; VENA CAVA FILTER SYSTEM

Model Number	31335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	10/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch history review: we have checked the manufacturing file of the involved batch which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported to us on this batch of vena cava filters released in february 2017.Investigation: no x-rays films or medical reports were returned for analysis.The information available is insufficient.No conclusion can be drawn about the root cause.This type of incident is a known potential adverse event of the implantation of vena cava filter.The review of our complaint data base does not show any other similar case since 2014.This is an isolated case.No corrective action is envisaged.
Event or Problem Description
Subject has history of hypertension, former smoker >1 year prior to enrollment, current malignancy, sob, and rle common femoral dvt.Contraindication to anticoagulation due to abnormal platelet count.Subject was admitted to hospital on (b)(6) 2017.On (b)(6) 2017 pt was consented and lp filter was placed without complication.Patient was discharged on (b)(6) 2017.On (b)(6) 2017, subject was sent for a ct a/p without contrast which demonstrated acute thrombosis from the ivc filter down into the bilateral common iliac veins with stranding around the ivc.Patient was continued on anticoagulation with heparin, symptomatic control for pain, and lasix for edema.Eventually pain and swelling started improving.Repeat ct scan revealed stable clot burden (date not provided).Heparin gtt was changed to lovenox and titrated based on anti-xa to 60 mg bid.On (b)(6) 2018, ct w/contrast impression showed no evidence of thrombosis.Subject on aspirin and rivaroxaban 10 mg daily.Filter thrombosis was considered resolved without sequelea on (b)(6) 2018.The pi considered the event expected and possibly related to the device.

• Brand Name: VENATECH LP
• Common Device Name: VENA CAVA FILTER SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• MDR Report Key: 9757798
• Report Number: 9612452-2020-00006
• Device Sequence Number: 11309028
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: 4038653918164
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K010485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2022
• Device Model Number: 31335
• Device Catalogue Number: 5010024
• Device Lot Number: 36916023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR