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

Catalog Number BXA063902E

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2021

Event Type  Injury  

Event Description

The following was reported to gore on 01/03/2024 from a retrospective study: on (b)(6) 2021, this 67-year-old patient underwent endovascular treatment for a thoracoabdominal aneurysm.The patient was treated with a cook t-branch device, five gore® viabahn® vbx balloon expandable endoprosthesis devices, bentley begraft, and amplatzer ii vascular plug.Gore vbx devices were placed in the superior mesenteric artery, bilateral renal arteries, and celiac trunk.The five vbx devices were successfully navigated to their intended location and successfully deployed.Device catheters were successfully removed.All five devices were noted as patent at the end of the procedure.On (b)(6) 2021, it was noted the patient had migration between the two covered stents in the left renal artery.Prolonged hospitalization was required for surgical reintervention.On (b)(6) 2022, the patient was admitted to the hospital.On (b)(6) 2022, the patient had an endovascular procedure in the left renal artery and a gore® viabahn® vbx balloon expandable endoprosthesis device (bxa065902e/23952971) was implanted in the left renal artery.On (b)(6) 2022, the patient was noted to have recovered/resolved without sequelae and was discharged from the hospital.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the study number with codes for the hospital and patient.H3 other code: as the device remains implanted, no further investigation can be performed.H6 evaluation codes investigation results c19 refers to the product history review.A review of the manufacturing records indicated the device met pre-release specifications.It is stated that the primary relationship for the event is device related, but other than vbx stent graft and gore accessory.Cbas® heparin surface incorporates carmeda-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.In the instruction for use for the gore® viabahn® vbx balloon expandable endoprosthesis the following is stated: adverse events potential clinical and device adverse events possible adverse events and complications that may occur with the use of this device or in any endovascular procedure and require intervention include, but are not limited to: migration w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: 18569678
• MDR Text Key: 333551607
• Report Number: 2017233-2024-04564
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: NO
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2023
• Device Catalogue Number: BXA063902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/30/2020
• 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
• Treatment: COOK T-BRANCH, BENTLEY BEGRAFT, AMPLATZER I
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 91 KG