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

Catalog Number	VBJR062502A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The investigation is ongoing.
Event or Problem 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.
Additional 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
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9313207
• Report Number: 2017233-2019-01133
• Device Sequence Number: 468895
• Product Code: PFV
• UDI-Device Identifier: 00733132623976
• UDI-Public: 00733132623976
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR