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

Catalog Number PAJR051502B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Stenosis (2263)

Event Date 12/13/2021

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 was reported to gore: on (b)(6) 2021, a gore® viabahn® endoprosthesis was intended for use in the superficial femoral artery for treatment of peripheral arterial disease.After the gore® viabahn® endoprosthesis was advanced up and over the aortic bifurcation to the left superficial femoral artery, the physician attempted to deploy the gore® viabahn® endoprosthesis.However, after approximately 50% deployed the deployment line broke.The physician attempted to salvage the gore® viabahn® endoprosthesis, but was unsuccessful.As the physician attempted to pull the gore® viabahn® endoprosthesis into the introducer sheath, the remaining gore® viabahn® endoprosthesis successfully deployed to complete the case.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 delivery catheter, deployment line, and deployment knob were returned and evaluated.No endoprosthesis was returned.The investigation was not able to confirm the report of deployment difficulty since the endoprosthesis was fully deployed from the catheter assembly and was not returned.Thus, a failure mode was not able to be confirmed.Cause of the reported event cannot be established based on evaluation of the returned delivery system and the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• 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: 13112473
• MDR Text Key: 283242323
• Report Number: 2017233-2021-02649
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PAJR051502B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1