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

Catalog Number BXA085902E

Device Problem Malposition of Device (2616)

Patient Problem Aneurysm (1708)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the study number with codes for the hospital and patient.As the device remains implanted, no further investigation can be performed.Evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing records indicated the lot met all pre-release specifications.The device remains implanted and was, therefore, not available for analysis.No clinical images enabling direct assessment of product performance were returned for evaluation.Cbas® heparin surface incorporates carmeda-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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: endoleak and/or endotension 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.

Event Description

The following was reported to gore from a retrospective study: on (b)(6) 2020, the patient underwent endovascular treatment for a thoraco-abdominal aneurysm type ii (degenerative) in the descending thoracic aorta.As fenestrated and branched graft a cook custom graft was used and a thoracic stent graft.As external branches a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device) was implanted in the celiac trunk, one vbx-device in the superior mesenteric artery, one vbx-device in the right renal artery and one vbx-device in the left renal artery including heparin used during procedure.The devices were implanted successfully and were patent at the end of the procedure.At discharge single antiplatelet therapy was prescribed.During a follow-up visit on (b)(6) 2020, imaging was performed (cta), which indicated an endoleak type 1c at the left renal artery because of an insufficient landing zone length.To solve the issue an endovascular reintervention was performed on (b)(6) 2020, namely a percutaneous transluminal angioplasty (pta) and an implantation of an additional vbx-device.The device was patent at the end of the procedure and there were no procedural complications.

• 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: 16598449
• MDR Text Key: 311848174
• Report Number: 2017233-2023-03811
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: DA
• 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: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: BXA085902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2019
• 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 CUSTOM MAIN BODY.
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 54 KG