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

Model Number BXA067902A

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/19/2021

Event Type  Injury  

Event Description

On (b)(6) 2020 the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using gore® excluder® thoracoabdominal branch endoprostheses (tambe) in the aaa1701 tambe pivotal study.On (b)(6) 2021 occlusion was observed in the gore® viabahn® vbx balloon expandable endoprosthesis used as a bridging stent in the patient's right renal artery.It was reported that the occlusion was suspected to be related to the sharp angle that the device takes as it bridges from the tambe device.Reportedly the patient had a decline in renal function but does not require hemodialysis.It was reported that the event is ongoing.No treatment has been performed or is planned for the future.There were no further reported issues and there were no reported issues with any other implanted devices.

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.Due to no device return, an investigation could not be performed.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.

• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14477887
• MDR Text Key: 292502206
• Report Number: 2017233-2022-02956
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637492
• UDI-Public: 00733132637492
• 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
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2023
• Device Model Number: BXA067902A
• Device Catalogue Number: BXA067902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/23/2022
• Date Device Manufactured: 03/06/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White