MAUDE Adverse Event Report: W.L. GORE AND ASSOCIATES, INC. VIAHBAHN ENDOPROTHESIS VASCULAR STENT-GRAFT; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	VBCR081001A
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	06/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Viabahn stent-graft being used to treat stenosis of av graft outflow vein.The stent-graft was situated perfectly in a straight vane segment, over a 0.038" bentson guidewire, which is our standard for this procedure.During attempted deployment, after approximately 2/3 of the stent have been expanded, deployment dashboard is suddenly struck and could not be pulled any further.Multiple attempts to get the court to release the remaining unopened stent-graft were unsuccessful.The wire was replaced with a super-stiff amplatz wire, which did not substantially change the configuration of the stent-graft; the cord would still not release the stent-graft.There was marked deformation and segmental particle expansion of the stent-graph.Finally, with intentionally excessive force, the [invalid] snapped, and the stent was left completely opened, resulting in obstruction of the target vessel.Attempts to extract the stent using a snare were unsuccessful.The graft had to be occluded to avoid extravasation around the mal-deployed sent.The patient was sent by ambulance to hospital, admitted for a management of this complication, observation, and surgical graft salvage.He needed acute femoral hd catheter for treatment of renal conditions (hyperkalemia, hypertension, fluid overload).Surgery was not willing to operate on a graft due to the potential difficulty reaching healthy target made.A long-term tunneled hemodialysis catheter was placed, and he was discharged with plans for a new av access creation.The otherwise good quality dialysis graft had to be sacrificed.Note that we have placed several hundreds of the viabahn stent-grafts in similar situations.On rare occasion, we had the deployed cord "stick" and meet some resistance; each time we have been able to overcome back with additional gentle traction.This is the first time we have had a deployment failure.Fda safety report id # (b)(4).

• Brand Name: VIAHBAHN ENDOPROTHESIS VASCULAR STENT-GRAFT
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE AND ASSOCIATES, INC.
• MDR Report Key: 8692458
• Report Number: MW5087289
• Device Sequence Number: 1942143
• Product Code: NIP
• UDI-Device Identifier: 00733132623525
• UDI-Public: (01)00733132623525
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VBCR081001A
• Device Catalogue Number: VBCR081001A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2019
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 64