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

Catalog Number	PHA051002A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.The engineering evaluation stated the following: when physically evaluated upon return, the following observations were made: the outer sheath was severed.The device was kinked at multiple locations along the catheter, including near the strain relief.The tear tube was severed in two locations, approximately 25 cm distal of the thumbwheel knot in the handle and approximately 80 cm proximal to the coupler bond.The lock slider was in the unlocked position.The outer sheath was locked distally, over the proximal edge of the stent.Approximately 37 mm of the distal end of the stent was uncovered.The stent displayed tensile damage and the constrained portion of the stent was translated distally on the catheter.Based on the device examination performed, no manufacturing anomalies were identified.
Event or Problem Description
The following information was reported to gore: on b)(6) 2018 a patient was undergoing treatment of a heavily calcified popliteal artery stenosis with a gore® tigris® vascular stent.An antegrade approach was utilized.The device was advanced over a.035" wooly wire through a 6fr terumo sheath.When the target location was reached deployment was initiated.Approximately 3-4 cm of the device expanded when deployment stopped.The deployment line snapped, however no resistance was felt prior in the deployment wheel.Then the deployment wheel was turning without additional device expansion.The delivery catheter was then cut open in attempts to retrieve the deployment line, but this was not successful.The sheath was advanced further to try and capture the device, which was eventually successful.The procedure was completed using a bare metal bard lifestent.There was no injury to the patient.

• 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: 7774668
• Report Number: 2017233-2018-00499
• Device Sequence Number: 16397069
• Product Code: NIP
• UDI-Device Identifier: 00733132636198
• UDI-Public: 00733132636198
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 07/16/2018

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: 07/19/2020
• Device Catalogue Number: PHA051002A
• Device Lot Number: 17560667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 65