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

Catalog Number	PHA051002A
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.Examination of the returned device revealed the following: the device was kinked at multiple locations along the catheter, including near the strain relief; the lock slider was in the unlocked position.This is inconsistent with the reported event description; approximately 8mm of the distal end of the stent was uncovered.The hp tube appeared bunched on the constrained portion of the stent; the constrained portion of the stent was positioned on the correct location on the catheter (not displaced) and did not appear compressed or stacked.Based on the device examination performed, no manufacturing anomalies were identified.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported to gore: during a sfa occlusion case, the first gore® tigris® vascular stent was implanted without incident.As the second gore® tigris® vascular stent was being advanced through the previously implanted gore® tigris® vascular stent, the doctor reported the device appeared to partially deploy and then began to 'accordion'.The device was removed without incident.The procedure was successfully completed using 2 additional gore® tigris® vascular stents.

• 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: 7803265
• Report Number: 2017233-2018-00510
• Device Sequence Number: 2365301
• Product Code: NIP
• UDI-Device Identifier: 00733132636198
• UDI-Public: 00733132636198
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/02/2018

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: 04/03/2021
• Device Catalogue Number: PHA051002A
• Device Lot Number: 18258775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• 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: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other