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

Device Problem Device Stenosis (4066)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/05/2021

Event Type  Injury  

Event Description

The following was reported to gore on (b)(6) 2024 from the (b)(6) study database: on (b)(6) 2021, this 73-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, and six bare metal stents.Gore vbx devices were placed in the celiac trunk, superior mesenteric artery and bilateral renal arteries.One of the gore® viabahn® vbx balloon expandable endoprosthesis devices in the celiac trunk was not successfully navigated to intended location of deployment, not deployed as intended, delivery catheters were successfully removed, and device was patent.The other four vbx devices were successfully navigated to their intended location and successfully deployed.Device catheters were successfully removed.All devices were noted as patent at the end of the procedure.On (b)(6) 2021, it was noted the patient had an occluded celiac artery.Hospitalization was required.Medical or surgical interventions and treatment were not required.It is noted that an angiogram was completed and the patient was noted to have not recovered/resolved from the adverse event.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the associated study number.C1: cbas® 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.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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19001783
• MDR Text Key: 338881048
• Report Number: 2017233-2024-04771
• 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: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• 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: N/A.
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male