MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE TIGRIS® VASCULAR STENT; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	PHA061002A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation in ongoing.
Event or Problem Description
The following was reported to gore: the patient presented for relining of a bare metal stent behind the knee.The gore® tigris® vascular stent would not deploy on the.018 guidewire.When the doctor attempted to remove the partially deployed device, the wire also came out.
Additional Manufacturer Narrative
Additional manufacturer narrative: patient identifier.Review of the manufacturing records verified that the lot met release requirements.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE TIGRIS® VASCULAR STENT
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8079122
• Report Number: 2017233-2018-00702
• Device Sequence Number: 215084
• Product Code: NIP
• UDI-Device Identifier: 00733132636297
• UDI-Public: 00733132636297
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: P160004
• 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): 12/11/2018

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: 05/24/2019
• Device Catalogue Number: PHA061002A
• Device Lot Number: 15835020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• 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: 11/16/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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: Other
• Patient Age: 73 YR