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

Catalog Number PHA051002A

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2018

Event Type  malfunction  

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 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
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL CENTRAL B/P; 1500 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; 9285263030
• MDR Report Key: 7803265
• MDR Text Key: 117854369
• Report Number: 2017233-2018-00510
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132636198
• UDI-Public: 00733132636198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2018
• Date Device Manufactured: 04/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other