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

Device Problems Collapse (1099); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Initial reporter health professional-initial reporter occupation: data not available as it was reported trough (b)(6).(b)(4).

Event Description

The following was reported to gore: a qualitative market research study was conducted on behalf w.L.Gore & associates in (b)(6) in which a mix of vascular surgeons, interventional cardiologists and interventional radiologists participated in telephonic interviews.The research was conducted between august 12 and october 11, 2021.For this case a vascular surgeon was asked, in terms of using the viabahn and vbx devices, for stent grafts, are there any specific challenges or drawbacks? the response was that it was heard during study groups from other hospitals, that when a patient received shiatsu massage, the vbx device was distorted and got blocked.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H6: code 213 ¿ the device either functioned as intended or a problem was not found.H6: code 4315 ¿ the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.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.

Manufacturer Narrative

Medical device problem code(s) and investigation conclusion code were updated per investigation.

Manufacturer Narrative

Case updated from serious injury to product malfunction.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12920486
• MDR Text Key: 283159033
• Report Number: 2017233-2021-02575
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention