MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number VBJR052502A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Stenosis (2263); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2022

Event Type  malfunction  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.

Event Description

The following information was reported to gore: on (b)(6) 2022, a gore® viabahn® endoprosthesis (vsx device) was intended for use in the left superficial femoral artery for treatment of stenosis.After the device was successfully implanted, the physician removed the delivery catheter.Upon removal of the delivery catheter it was discovered that the distal tip had separated from the catheter inside the patient.An angiogram was performed and the distal tip was located in the implanted device.The decision was made to advance an additional 5mm x 5cm vsx device and pin the distal tip to the wall of the previously implanted vsx device.A final angiogram was performed to verify that the distal tip was pinned against the wall and the procedure was completed.The patient did not experience any adverse consequences.

Manufacturer Narrative

Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.The cause of the reported primary device failure mode, distal tip separation during removal, could not be confirmed.No items were returned for evaluation; however, the device serial number was provided allowing for a review of the bonding process for the device.Review of process data yielded no evidence of a missing distal tip bond.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

Manufacturer Narrative

Revised h6: health effect - clinical code and investigation findings code.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14606369
• MDR Text Key: 293466433
• Report Number: 2017233-2022-02991
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623938
• UDI-Public: 00733132623938
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2022

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 Model Number: VBJR052502A
• Device Catalogue Number: VBJR052502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 07/13/2022; 08/18/2022
• Supplement Dates FDA Received: 07/13/2022; 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2021
• 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: 74 YR
• Patient Sex: Male