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

Catalog Number	PHA050602A
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met pre-release specifications.
Event or Problem Description
On (b)(6) 2019, the patient being implanted with a gore® tigris® vascular stent in the popliteal artery.A 0.35 guidewire was reportedly used during the procedure.It was reported during deployment the device released half way and suddenly locked not allowing the device to fully deploy.Reportedly the physician stated it is unknown what caused the partial deployment.The device was able to be pulled back into the 8fr sheath and withdrawn from the patient.No additional adverse events were reported.
Additional Manufacturer Narrative
Added a1: patient identifier.Corrected g5: combination product (yes).
Additional Manufacturer Narrative
H1: corrected type of report (changed to malfunction).H6: corrected conclusion code.Engineering evaluation state, based on the available returned device, the following observations were made: the device was kinked at multiple locations along the catheter, including near the strain relief.The lock slider was in the unlocked position.The outer sheath was locked distally, over the proximal edge of the stent.Approximately 11mm of the distal end of the stent was uncovered.Upon disassembly of the handle, the inner shaft was kinked and folded at the location of the pulley within the handle.Based on the device examination performed, no manufacturing deficiencies 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: 9267282
• Report Number: 2017233-2019-01101
• Device Sequence Number: 1735208
• Product Code: NIP
• UDI-Device Identifier: 00733132636150
• UDI-Public: 00733132636150
• 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,Followup
• Report Date (Section B): 11/27/2019

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: 10/17/2021
• Device Catalogue Number: PHA050602A
• Device Lot Number: 20158617
• 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: 11/01/2019
• Supplement Report FDA Received Date: 11/21/2019; 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1