MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Model Number BXA093901A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/09/2020

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

On (b)(6) 2020, the patient was being implanted with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) to treat stenosis of the brachiocephalic artery.An 8 fr silk road sheath was used during the procedure.It was reported the vbx was advanced and implanted with no issue.However, during withdrawal of the catheter resistance was met.The catheter was able to be withdrawn through the sheath.It was noted the balloon had become separated from the catheter and was located within the portion of the sheath in the patient.The sheath and balloon were successfully withdrawn from the patient together.The patient tolerated the procured.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.

Manufacturer Narrative

Updated h6 investigation conclusion - 4315 cause not established.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• 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: 11098137
• MDR Text Key: 225319839
• Report Number: 2017233-2020-01565
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637348
• UDI-Public: 00733132637348
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2022

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 Expiration Date: 12/01/2022
• Device Model Number: BXA093901A
• Device Catalogue Number: BXA093901A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 04/01/2021; 06/28/2022
• Supplement Dates FDA Received: 04/01/2021; 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1