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

Catalog Number	VBJR051502A
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907); Activation Failure (3270)
Health Effect - Clinical Codes	Occlusion (1984); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported to gore by the doctor: the patient presented with total occlusion of the sfa.According to the doctor, the deployment line broke after the gore® viabahn® endoprosthesis (viabahn) was 80 percent deployed.The physician then performed a popliteal stick and access.This allowed access for a guide wire and pta balloon to be placed in the partially deployed viabahn.The pta balloon was inflated within the viabahn, successfully deploying the viabahn.It was reported that the patient is doing well.
Additional Manufacturer Narrative
A2 - patient's dob was entered.A3 - patients sex entered.A4 - patient's weight was entered.B7 - updated preexisting medical conditions.G5 - otc product - selected 'no'.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8895455
• Report Number: 2017233-2019-00647
• Device Sequence Number: 1561659
• Product Code: PFV
• UDI-Device Identifier: 00733132623921
• UDI-Public: 00733132623921
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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: 04/24/2022
• Device Catalogue Number: VBJR051502A
• Device Lot Number: 20739389
• Was Device Available for Evaluation?: No
• 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: 08/14/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 104