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

Model Number BXA067902A

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

Patient Problem Stenosis (2263)

Event Date 09/15/2020

Event Type  Injury  

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

Event Description

On (b)(6) 2020 a patient underwent aortic debranching within the (b)(6) clinical study.A gore® viabahn® vbx balloon expandable endoprosthesis was utilized in the right renal artery.On (b)(6) 2020 a right renal artery stent stenosis was noted.This was treated with catheter based tpa, suction thrombectomy and placement of a right renal artery everflex stent.

• 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; phoenix, AZ 85024 ; 9285263030
• MDR Report Key: 10662625
• MDR Text Key: 211473166
• Report Number: 2017233-2020-01344
• 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
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2020

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: 02/04/2023
• 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: 09/23/2020
• Initial Date FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 66