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

Catalog Number PHB070802

Device Problem Positioning Failure (1158)

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

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.(b)(4).When physically evaluated upon return, the following observations were made: the handle was returned disassembled.The tear tube, inner shaft, and outer sheath were severed at the strain relief.The outer sheath was locked distally, over the proximal edge of the stent.Approximately 38mm of the distal end of the stent was uncovered.The coupler bond was difficult to remove from the outer sheath.Upon removal of the outer sheath, the proximal edge of the coupler bond was bunched.Based on the device examination performed, it was unable to be determined if any anomalies could be attributed to the manufacture of the device.There is no indication that the coupler bond was incorrectly assembled.(b)(4).

Event Description

The patient presented with a diseased lesion within the right external iliac artery which was intended to be treated with a gore® tigris® vascular stent.It was stated that a retrograde approach was used to gain access to the target lesion where it was reported to gore that abnormal force was required to pass the bifurcation from the left side.Further it was stated that when the gore® tigris® vascular stent was positioned on the target lesion and device deployment initiated, the stent deployed approximately until the half of the device.As it was not possible to continue device deployment, the device handle was opened and the deployment line pulled, without success.The remaining, constrained portion of the stent did not deploy.Consequently, the partial deployed tigris stent was removed from the external iliac artery, where the guidewire was kept in place, and the procedure was completed implanting another gore® tigris® vascular stent.It was stated that the patient¿s vessels were not injured when the device was retracted and that the patient was doing well following the procedure.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; flagstaff, AZ ; 9285263030
• MDR Report Key: 7380616
• MDR Text Key: 104142619
• Report Number: 2017233-2018-00197
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2020
• Device Catalogue Number: PHB070802
• Device Lot Number: 17269005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• 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 Age: 82 YR
• Patient Weight: 60