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

Catalog Number BXA075901J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2021

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2021, a patient underwent endovascular treatment of an abdominal aortic aneurysm and both iliac artery aneurysms using gore® excluder® aaa endoprostheses, gore® excluder® iliac branch endoprostheses and gore® viabahn® vbx balloon expandable endoprostheses (vbx) with embolized a left inferior gluteal artery using plug (plug 4) and an inferior mesenteric artery.Hgb161407a was implanted in a left internal iliac artery.Bxa115901j was implanted to extend distally.Bxa074901j was implanted to extend distally to a left superior gluteal artery.On unknown date in (b)(6) 2021, at a follow up, a computed tomography revealed occlusion of hgb161407a, bxa115901j and bxa074901j.No treatment for the occlusion was reported.The physician stated that the occlusion could be caused by a weak out flow and it might have been better to perform a dual antiplatelet therapy.Reportedly, no kink or compression of the stent grafts of hgb161407a, bxa115901j and bxa074901j were observed.

Manufacturer Narrative

Revised: adverse event - yes.

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.

• 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: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12807072
• MDR Text Key: 280771108
• Report Number: 2017233-2021-02532
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• 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,Followup
• Report Date: 06/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2023
• Device Catalogue Number: BXA075901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male