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

Catalog Number PAJR062502E

Device Problem Activation Failure (3270)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.The entire device was returned to w.L.Gore & associates for investigation.The following observations were made: there was a break in the distal shaft, upon which the endoprosthesis is mounted, at the transition.Approximately 0.3 cm of the distal shaft was exposed at the tip and 0.4 cm at the transition.The endoprosthesis was longitudinally compressed towards the center of the distal shaft.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.Based on the evaluation 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.The reported issue codes are representative of this event.

Event Description

It was reported that a gore® viabahn® endoprosthesis with propaten bioactive surface did not deploy at the distal end.It was stated, that therefore the physician has withdrawn the viabahn® endoprosthesis from the patient.

Manufacturer Narrative

H6-code 213.A review of the manufacturing records indicated the device met pre-release specifications.The device was returned to w.L.Gore & associates for investigation.The following observations were made: - the entire device was returned.- the deployment line appeared to be taut within the hub.- approximately 0.3cm of the distal shaft was exposed at the tip and 0.4cm at the transition.- the endoprosthesis was longitudinally compressed towards the center of the distal shaft.- the inner braided constraining line was deployed approximately 0.2cm.The endoprosthesis was fully constrained by the constraint sleeve.- deployment was able to be continued with traction on the deployment line at the endoprosthesis.Based on the evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.The engineering evaluation states, that there was no expansion of the device as suspected initially.Based on this finding the reporting decision was re-evaluated.It was determined, that the present event is considered to be not reportable.Therefore this mfr report is being retracted.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9801876
• MDR Text Key: 216150540
• Report Number: 2017233-2020-00161
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2020
• Device Catalogue Number: PAJR062502E
• Device Lot Number: 17377743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 95