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

Model Number	31335
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Batch history review: we have checked the manufacturing file of batch nr 36947576 which complies with our specifications and does not present any discrepancy.No other complaint has been reported to us on this batch of vena cava filters released in may 2019.Investigation results we have received 6 pictures for evaluation.Picture 1 & 2: these ct scan were taken the day of the implantation procedure, before the filter placement (vein diameter = 2,1cm).Picture 3: this x ray picture shows the vein just before placing the filter.Picture 4: it shows the filter correctly expanded and placed in the ivc, in infrarenal location.The reason for migration is not apparent on the picture.Picture 5: 4 days after the implantation.It shows that the filter migrated to intrahepatic ivc.It was tilt.Picture 6: coronal ct scan.4 days after the implantation.It shows that the filter migrated at the entrance of the right atrium.However, this pictures do not allow us to venture a hypothesis concerning the origin of this incident.Conclusion: the elements received do not allow us to conclude on the origin of the migration of the venatech lp filter 4 days after its perfect deployment.The migration of the vena cava filter is a known complication of the implantation of this type of device.We can hypothesize that a huge ivc expansion is at the origin of this migration (ie.Extreme vasalva).This type of migration is a rare incident.The complaint rate is <0,01% and acceptable compared to the ratio benefit/risks.Consequently, no corrective action is envisaged.
Event or Problem 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: VENATECH LP
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• MDR Report Key: 10069901
• Report Number: 9612452-2020-00017
• Device Sequence Number: 19771366
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: 04038653918164
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2024
• Device Model Number: 31335
• Device Catalogue Number: 5010024
• Device Lot Number: 36947576
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 05/19/2020
• 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: Death; Life Threatening