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

Catalog Number BXA063902J

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

Patient Problem Stenosis (2263)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.C1:heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of the manufacturing records for the device could not be performed as a valid lot number was not provided.Author: yosuke yamamoto, et al.Literature title: two cases of stent graft treatment for wide-neck saccular renal artery aneurysm (rundback type 1) difficult to be coil-embolized.Source: the journal of japanese college of angiology, 2023: 63(suppl.) p.S192 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 literature was reviewed: yosuke yamamoto, et al.Two cases of stent graft treatment for wide-neck saccular renal artery aneurysm (rundback type 1) difficult to be coil-embolized.The journal of japanese college of angiology, 2023: 63(suppl.) p.S192 case 2: the patient was a 38-year-old man.A wide-neck saccular aneurysm of 23 × 18 × 17 mm was found in the main trunk of the right renal artery.Stent-assisted coil embolization was planned at another hospital, but the proximal end of the stent deviated into the aneurysm; therefore, the procedure was discontinued and the patient was referred to the reporting hospital.A 7 fr guiding sheath was inserted through the right common femoral artery and a microwire passed through a strut of the deviated stent.The strut was dilated with a 5 mm diameter pta balloon, and two gore® viabahn® vbx balloon expandable endoprostheses (6mm × 39mm, 6mm × 29mm) were implanted.Confirming no endoleaks by angiography, the procedure was concluded.Postoperatively, the aneurysm was thrombosed and shrunk.Antiplatelet agents were continued with 2 drugs for 6 months and then with 1 drug.During the postoperative clinical course, stenosis appeared and thus, a stent was additionally placed.Thereafter, the devices have remained patent for 4 years without restenosis.

Manufacturer Narrative

H6: code d12 was added to the investigation conclusions.The ifu was reviewed, and the following statement was found to be applicable: device complications and adverse events include stenosis and/or occlusion of stent graft and/or vessel.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: PRL / 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: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18637911
• MDR Text Key: 334491379
• Report Number: 2017233-2024-04593
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA063902J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 38 YR
• Patient Sex: Male