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

Catalog Number	PHA051002A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device available for evaluation? yes, but actual device was discarded at user facility.Photo was received from user facility and evaluated by engineer.Engineering evaluation state, based on the available photograph, the following observations were made: there appears to be blood on the device, which is consistent with the reported event description.Several rows of the distal end of the stent were uncovered.The uncovered portion of the stent appeared expanded.The distal and proximal regions of the constraint sleeve appeared bunched.Based on the device photograph examination performed, no manufacturing anomalies were identified.Review of device manufacturing record history confirmed device met pre-release specifications.Device was not returned; therefore, direct product analysis was not possible.
Event or Problem Description
During treatment in the patient's superficial femoral artery (sfa) due to occlusive disease, a gore® tigris® vascular stent (stent) was advanced after the artery was predilated by a 3mm balloon.It was reported that during advancement, there was difficulty pushing the delivery catheter past the proximal sfa.The physician realized that about 2cm of the stent was unsheathed at the distal tip and the constraint sleeve appeared to be displaced.The delivery catheter was pulled back through the introducer sheath and removed from the patient.As reported, the constraint sleeve likely got stuck on vessel plaque as the device was pushed.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
H6 - code 4112.Code was updated (previously reported as 4114).Suspected device was discarded at user facility.Engineering evaluation was performed based on photo that was received.

• 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: 9119530
• Report Number: 2017233-2019-00912
• Device Sequence Number: 19361197
• Product Code: NIP
• UDI-Device Identifier: 00733132636198
• UDI-Public: 00733132636198
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 11/08/2019

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: 09/13/2021
• Device Catalogue Number: PHA051002A
• Device Lot Number: 20123999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• 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: 09/25/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 50