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

Catalog Number PHB060402

Device Problem Activation Failure (3270)

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

Event Date 08/31/2018

Event Type  malfunction  

Manufacturer Narrative

When the medical device was physically evaluated upon return, the following observations were made: the device was kinked at multiple locations along the catheter, including near the strain relief.Approximately 2mm of the distal end of the stent was uncovered.Based on the device examination performed, no manufacturing anomalies were identified.

Event Description

The patient presented with a diseased lesion which was intended to be treated with a gore® tigris® vascular stent.It was reported to gore that the gore® tigris® vascular stent was inserted through a 6fr introducer sheath from cook where a cross over approach was used.It was stated that some tension and difficulties were experienced while the medical device was advanced to the target lesion.It was reported to gore that after the security lock of the gore® tigris® vascular stent was unlocked, an attempt was made to reposition the medical device to the target lesion.It was stated that it was not possible to reposition the medical device as well as to initiate the deployment.Therefore the decision was made to remove the gore® tigris® vascular stent.It was stated that the patient was doing well following the procedure.

• 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: barbara ulrich ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8011762
• MDR Text Key: 126534355
• Report Number: 2017233-2018-00653
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2019
• Device Catalogue Number: PHB060402
• Device Lot Number: 15861014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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