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

Model Number PHS051002A

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

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

Event Date 07/16/2018

Event Type  malfunction  

Event Description

Stent was inserted into patient through right groin access.The stent was bent in some fashion and it would not deploy.The wire was then stuck in the stent.The wire and the stent were removed from the patient via right groin access and placed into a red biohazard bag.

• Brand Name: GORE TIGRIS VASCULAR STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC; 1505 north fourth st.; flagstaff AZ 86004
• MDR Report Key: 8353246
• MDR Text Key: 136599514
• Report Number: 8353246
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PHS051002A
• Device Catalogue Number: PHS051002A
• Device Lot Number: 18023843
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 90