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

Model Number	17229409A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The "nose cone" (tip) broke off the instrument inside of the patient.

• Brand Name: GORE
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE AND ASSOCIATES, INC. ; flagstaff AZ 86004
• MDR Report Key: 7506279
• Report Number: MW5077140
• Device Sequence Number: 10833810
• Product Code: NIP
• UDI-Device Identifier: 00733132617722
• UDI-Public: (01)00733132617722
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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: 08/07/2020
• Device Model Number: 17229409A
• Device Catalogue Number: TGU373710
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR