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

Catalog Number BXA062902E

Device Problem Crack (1135)

Patient Problem Aneurysm (1708)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, no investigation of the device can be performed.Phr-review: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.Imaging evaluation summary: the images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.Gore cannot guarantee the images provided are complete, accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.Images received via (email) with no patient identifier or date of acquisition in image.Images provided do not allow for evaluation in relationship to this event.Images cannot be manipulated in anyway.Anatomy or location of stent grafts cannot be identified.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

It was reported to gore that patient underwent endovascular treatment for an abdominal aortic aneurysm (aaa) with a gore¿ viabahn¿ vbx balloon expandable endoprosthesis (vbx-device).It was stated that the vbx-device leaked in the middle of the stent after flaring with an 8mm x 2cm dilation balloon in the left renal artery during fenestrated cases.It was reported that to stop the type 3 endoleak another vbx-device was placed successfully into the leaking vbx-device.The result was good and there were no further issues for the patient.

Manufacturer Narrative

Report # 2017233-2021-01974 is being retracted.After further evaluation, this complaint was deemed not reportable.There was no harm to patient, the procedure ended successfully with additional device deployment.H1: update to 'other' for report retraction.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11807432
• MDR Text Key: 261721915
• Report Number: 2017233-2021-01974
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: BE
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

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: 01/07/2024
• Device Catalogue Number: BXA062902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2021
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male