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

Model Number VBHR060502A

Device Problems Break (1069); Entrapment of Device (1212); Physical Resistance/Sticking (4012); Separation Problem (4043)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2022

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following information was reported to gore: on (b)(6) 2022, the patient was being treated for a stenotic lesion in a iliac artery using a gore® viabahn® endoprosthesis with heparin bioactive surface.The vessel was pre-dilated prior to the advancement of the device.The device was advance and deployed in its intended location with no reported issue.Resistance was noted as the delivery catheter was being removed from the patient.As the delivery catheter was removed from the guidewire it was noted that the distal shaft was not attached.The distal shaft was separated from the delivery catheter and was located in the patients common iliac artery.The physicians suspected cause of the distal shaft separation was excessive calcification in the vessel.Another gore device was implanted to pin the distal shaft to the vessel wall.The patient tolerated the procedure.

Manufacturer Narrative

Added h6 evaluation codes.Engineering evaluation: the dual lumen, hub, and transition components were returned to gore for evaluation.Evaluation of returned device confirms the reported distal shaft separation, but the cause for the distal shaft separation cannot be confirmed without the distal shaft.The transition bond is intact with no evidence of the distal shaft remaining in the transition.Updated investigation conclusion.

• 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: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13675883
• MDR Text Key: 290571637
• Report Number: 2017233-2022-02786
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132622764
• UDI-Public: 00733132622764
• 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
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VBHR060502A
• Device Catalogue Number: VBHR060502A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1