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

Catalog Number BXAL085902B

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/25/2021

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 was undergoing treatment of bilateral iliac artery aneurysm with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.Following deployment of the (b)(4) on the right, attempts were made to access the internal iliac artery with a wire, however the wire kept landing subintimally, so the right side was left untreated.Attempts were made to treat the left side with the gore® excluder® iliac branch endoprostheses, but the internal iliac artery was too short.A decision was made to use a gore® viabahn® vbx balloon expandable endoprosthesis.Following implantation of the viabahn® vbx balloon expandable endoprosthesis, blood flow was sluggish and by the end of the procedure this device was occluded, either due to poor outflow or a distal dissection possibly from the shoulders of the viabahn® vbx balloon expandable endoprosthesis balloon.Some time following the procedure, the patient developed spinal cord ischemia due to lack of perfusion to the inferior mesenteric and iliac arteries.An unexplained stroke was also recognized.This report addresses the occlusion of the gore® viabahn® vbx balloon expandable endoprosthesis.

Manufacturer Narrative

H.6.Results code 1: 3233 a review of the manufacturing, sterilization and heparin coatings records verified the lot met all pre-release manufacturing and sterilization 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: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12422160
• MDR Text Key: 276651549
• Report Number: 2017233-2021-02331
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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
• Report Date: 11/15/2021

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: 02/02/2023
• Device Catalogue Number: BXAL085902B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2020
• 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; Other