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

Model Number BXA065902A

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 01/06/2021

Event Type  Injury  

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) 2020 a patient underwent thoracoabdominal aortic aneurysm treatment in the (b)(6) clinical study.A gore® viabahn® vbx balloon expandable endoprosthesis was utilized in thee right renal artery.On (b)(6) 2021, the right renal artery stent was found to be severely stenosed.On (b)(6) 2021 a reintervention took place whereby an additional stent was placed to treat the stenosis.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

Manufacturer Narrative

H6: updated.

• 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: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11233534
• MDR Text Key: 228851471
• Report Number: 2017233-2021-01626
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637218
• UDI-Public: 00733132637218
• 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
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2022
• Device Model Number: BXA065902A
• Device Catalogue Number: BXA065902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2019
• 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; Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 77 KG