MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number VBJR061502A

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The following information was reported to gore: on (b)(6) 2020 the patient was being treated for occlusive disease in the patients superficial femoral artery using gore® viabahn® endoprosthesis with propaten bioactive surface.It was reported the deployment line was pulled and only 25 percent of the device expanded.The physician stated the suspected cause of the device only partially deploying is unknown.The device was explanted from the patient.Another gore® viabahn® endoprosthesis was used to complete the procedure.The patient tolerated the procedure.

Manufacturer Narrative

Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Engineering evaluation task was performed and the results are: the endoprosthesis, part of the deployment line, deployment knob, and delivery catheter were returned.There was approximately 17 cm of deployment line attached to the endoprosthesis where deployment appears to had stopped.The line had two 8 cm single at the end of the deployment line which appeared to be tangled in a biological substance, see returned sample image 2.The delivery catheter was returned in two pieces and appeared to have been cut.The first piece included the hub and a part of the distal shaft, upon which the endoprosthesis was mounted, that was approximately 7 cm long.The other piece of the distal shaft had the endoprosthesis on it and measured approximately 6 cm long there was a kink in the distal shaft at the transition and the second piece of distal shaft was kinked in multiple locations.The endoprosthesis was partially expanded, approximately 2 cm was still constrained by the inner braided constraining line.The endoprosthesis was also damaged and had body delamination through the endoprosthesis.Deployment was able to continue with traction on the deployment line at the endoprosthesis.Engineering evaluation conclusion is inconclusive as it relates to the event description.The reported issue codes are representative of this event.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Manufacturer Narrative

Corrected d1/2 brand name, product code, and common device name.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10311832
• MDR Text Key: 199985233
• Report Number: 2017233-2020-01045
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623747
• UDI-Public: 00733132623747
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: VBJR061502A
• Device Catalogue Number: VBJR061502A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR