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

Model Number BXA057902A

Device Problem Obstruction of Flow (2423)

Patient Problem Pain (1994)

Event Date 01/23/2021

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) 2021 a patient underwent treatment of a thoracoabdominal aortic aneurysm in the aaa17-01 (b)(6) study.Gore® viabahn® vbx balloon expandable endoprostheses were used in the renal arteries.On (b)(6) 2021 the left renal artery was found to be occluded.The patient was treated with medication for flank pain, which prolonged hospitalization.

Manufacturer Narrative

B.7.Updated.H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release 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
• MDR Report Key: 11325351
• MDR Text Key: 233278373
• Report Number: 2017233-2021-01668
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637454
• UDI-Public: 00733132637454
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Model Number: BXA057902A
• Device Catalogue Number: BXA057902A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 120