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

Catalog Number PAJR051502B

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2019

Event Type  malfunction  

Event Description

The following information was reported to gore: on (b)(6) 2019 a patient was undergoing treatment of a superficial femoral artery occlusion with a gore® viabahn® endoprosthesis with propaten bioactive surface.Access was obtained and a terumo sheath was introduced.When the device was advanced and positioned, deployment was initiated.Mid deployment, the deployment line became hard to pull.Additional force was applied to pulling the deployment line and additional stent deployment was observed, but then the deployment line became stuck on the delivery catheter and the stent would not separate from the delivery catheter.An attempt was made to withdraw the partially deployed stent through the introducer sheath.It was possible to recapture some of the stent in the sheath, but the stent and sheath ultimately had to be removed simultaneously in order to remove the partially deployed device.Another gore® viabahn® endoprosthesis with propaten bioactive surface was advanced and deployed without incident.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.H.6.Results code 2: 213: the engineering evaluation stated the following: the endoprosthesis, delivery catheter, introducer sheath, and part of the deployment line were all returned.The introducer sheath was not evaluated as it was not a gore product.The deployment line section that was returned measured 29 cm in length, with single fibers coming from the end measuring 0.2cm and 0.3cm.Part of the deployment line is still connected to the distal shaft, upon which the endoprosthesis was mounted.The endoprosthesis was fully expanded.There appeared to be delamination approximately 1.5 cm from the contoured edge of the endoprosthesis.A hole was observed in the delaminated portion of the graft.Additional delamination was observed approximately 0.5 cm from the straight cut edge of 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.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8858370
• MDR Text Key: 154304618
• Report Number: 2017233-2019-00594
• 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
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2022
• Device Catalogue Number: PAJR051502B
• Device Lot Number: 20639671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 77