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

Catalog Number PAJR081002B

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2017

Event Type  malfunction  

Event Description

On (b)(6) 2019 a patient was undergoing treatment of an aneurysm in a very tortuous profundal artery with a gore® viabahn® endoprosthesis with propaten bioactive surface.It was not possible to advance the stent to the target treatment zone, so the device needed to be withdrawn in order to gain further purchase with the sheath.When the device was attempted to be withdrawn, difficulty was encountered when attempting to re-sheath the device.This device, pajr081002b had partially expanded before removal from the patient.The case was completed successfully with several additional gore® viabahn® endoprostheses with propaten bioactive surface.There was no adverse outcome for the patient.

Manufacturer Narrative

Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

Manufacturer Narrative

H.6.Results code 2: 213: the engineering evaluation stated the following: the devices were returned to w.L.Gore & associates for investigation.The following observations were made: 1st device.The entire device was returned with an introducer sheath; however, the introducer sheath was not evaluated as it was not a gore product.Approximately 3 cm of the distal shaft, upon which the endoprosthesis is mounted, was exposed at the transition.The endoprosthesis was longitudinally compressed towards the tip.The outer braided constraining line was deployed approximately 2cm.The remainder of the device was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.Engineering evaluation conclusion is inconclusive as it relates to the event description.2nd device.The entire device was returned.There was approximately 34 cm of deployment line between the hub and deployment knob.The deployment line was fully intact and attached to the distal shaft, upon which the endoprostheis was mounted.There was a kink in the dual lumen approximately 15 cm from the hub.Approximately 0.6 cm of the distal shaft, upon which the endoprosthesis was mounted, was stretched about 4 cm from the transition towards the tip.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.Engineering evaluation conclusion is inconclusive as it relates to the event description.3rd device.The entire device was returned.A guidewire was also returned, which was not evaluated as it was not a gore product.There was approximately 32 cm of deployment line between the hub and deployment knob.There was a kink in the dual lumen approximately 85 cm from the hub end.Approximately 5.5 cm of the distal shaft, upon which the endoprosthesis was/is mounted, was exposed at the transition.The endoprosthesis was longitudinally compressed towards the tip.Approximately 4 cm of the endoprosthesis was expanded on the tip end.The remainder of the endoprosthesis was constrained by the inner braided constraining line.Endoprosthesis exhibited delamination about 1 cm from the straight cut end.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.Engineering evaluation conclusion is inconclusive as it relates to the event description.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9299615
• MDR Text Key: 193653001
• Report Number: 2017233-2019-01128
• 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
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2022
• Device Catalogue Number: PAJR081002B
• Device Lot Number: 20725897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 75