MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number JHJR081502J

Device Problems Material Separation (1562); Activation Problem (4042)

Patient Problem Occlusion (1984)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.The delivery catheter was returned to gore for evaluation.The investigation is ongoing.

Event Description

The following was reported to gore by the doctor: on (b)(6) 2018, the patient underwent endovascular repair for occlusion of the right superficial femoral artery using gore® viabahn® endoprosthesis with heparin bioactive surface.The first endoprosthesis was implanted without issue.During deployment of the second endoprosthesis, the deployment line broke.The delivery catheter was withdrawn and the distal shaft, with the partially deployed endoprosthesis, was observed to be detached.Attempt was made to snare the partially deployed endoprosthesis.It was finally decided to pin the endoprosthesis, using two bare metal stents, to the vessel wall.Good distal blood flow was confirmed, and the procedure was concluded.

Manufacturer Narrative

Additional manufacturer narrative: examination of the returned device revealed the following: the deployment knob, deployment line, endoprosthesis, and the distal tip were not returned; the majority of the distal shaft, upon which the endoprosthesis was mounted, was not returned; the rest of the delivery catheter was returned; the distal shaft appeared to be broken at approximately 0.1 cm past the transition.Based on the device examination performed, no manufacturing anomalies were identified.Gore has been notified that dicom images will be provided.The investigation is ongoing.

Manufacturer Narrative

Additional manufacturer narrative: b7.- relevant medical history d11.- concomitant medical products - clopidogrel 75, artist (2.5), warfarin (2), olmetec (20), lansoprazole (15), allegra (60) × 2, cilostazol (100) × 2, lasix (40) morning, noon , bellaprost (20) 2 t × 3, arrowsen before sleep, non-hd day, celecox (100), tiona (250) × 3, regpara (25), carfina (0.25) evaluation of the returned images confirmed a deployed bare mental stent and the undeployed gore® viabahn® endoprosthesis with heparin bioactive surface.The gore® viabahn® endoprosthesis with heparin bioactive surface appears to be pushed against the vessel wall by the bare metal stent.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7763826
• MDR Text Key: 116557288
• Report Number: 2017233-2018-00496
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• 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,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2020
• Device Catalogue Number: JHJR081502J
• Device Lot Number: 17508114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR