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

Catalog Number PHA050602A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the lot met pre-release specifications.

Event 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stated it is unknown what caused the partial deployment.The device was able to be pulled back into the 8fr sheath and withdrawn from the patient.No additional adverse events were reported.

Manufacturer Narrative

Added a1: patient identifier.Corrected g5: combination product (yes).

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
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9267282
• MDR Text Key: 165564135
• Report Number: 2017233-2019-01101
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132636150
• UDI-Public: 00733132636150
• Combination Product (y/n): N
• PMA/PMN Number: P160004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/21/2019; 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1