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

Catalog Number	VBJR061502A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, this patient was implanted with a gore® viabahn® endoprosthesis to treat an in-stent restenosis in the left superficial femoral artery.On (b)(6) 2019, the patient presented with pain at rest in the lower left leg.On (b)(6) 2019, an angiogram of the left lower leg was performed.A repeat intervention was performed; however, details were not provided.
Additional Manufacturer Narrative
H10/11: additional manufacturer narrative/corrected data - h6: conclusion code: 4315.Additional information was received: patient underwent a left femoral-popliteal above knee bypass on (b)(6) 2019 to treat the critical limb ischemia.The ischemia was resolved with the treatment.
Additional Manufacturer Narrative
H10/11: additional manufacturer narrative/corrected data.After further review, this event classifies as a well-known event, as the event involves thrombosis, stenosis, re-stenosis, or loss of patency including partial and total occlusion in peripheral arterial disease (pad) and arteriovenous applications occurring greater than 30 days post implant.Therefore, this report is retracted.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8377839
• Report Number: 2017233-2019-00115
• Device Sequence Number: 222245
• Product Code: PFV
• UDI-Device Identifier: 00733132623747
• UDI-Public: 00733132623747
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: VBJR061502A
• Device Lot Number: 15172136
• 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; Not provided
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 03/12/2019; 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 55