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

Catalog Number VBJR062502A

Device Problem Material Separation (1562)

Patient Problem Occlusion (1984)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the manufacturing records verified that the lot met release requirements.The investigation is ongoing.

Event Description

The following was reported to gore by the hospital: the patient presented for a right lower extremity case.The gore® viabahn® endoprosthesis separated from the delivery catheter prior to deployment.

Manufacturer Narrative

Corrected data: h1.Type of reportable event.H6.Results code 2.H6.Conclusions code 1.Additional manufacturer narrative: examination of the returned device revealed the following: the entire device was returned with an introducer sheath; the introducer sheath was not evaluated as it was not a gore product; there was a kink in the distal shaft, upon which the endoprostheis was mounted, at the transition; approximately 1.5 cm of the distal shaft was exposed at the transition; the endoprosthesis was longitudinally compressed towards the tip.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.The engineering evaluation revealed there was no evidence of device detachment as originally reported by the hospital.Through the investigation it was revealed that the distal shaft was kinked and no serious injury to the patient was reported to gore.Therefore this event, originally reported as a malfunction, is not considered a reportable event.We have no reason to believe that this product did not meet its performance specifications.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9313207
• MDR Text Key: 166381723
• Report Number: 2017233-2019-01133
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623976
• UDI-Public: 00733132623976
• 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: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2022
• Device Catalogue Number: VBJR062502A
• Device Lot Number: 21005223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR