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

Model Number BXA072902A

Device Problem Obstruction of Flow (2423)

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 04/29/2022

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Due to no device return, an investigation could not be performed.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 information was reported to gore: on (b)(6) 2022 a patient was treated for an abdominal aortic aneurysm using a cook evar device in combination with the gore® viabahn® vbx balloon expandable endoprosthesis within the left and right renal arteries as well as the superior mesenteric artery.During the index procedure, thrombosis was identified within the gore® viabahn® vbx balloon expandable endoprosthesis.Additionally, it was stated that physician identified thrombosis in several vessels throughout the body (vessels unknown).The patient tolerated the procedure.On the same day, post procedure, the physician stated that bowel necrosis was observed due too thrombosis.The physician stated the patient will be monitored.On (b)(6) 2022 the patient expired.It was stated by the physician that there was occlusion observed within the gore® viabahn® vbx balloon expandable endoprosthesis devices.The physician stated there is no allegation of device deficiency nor is there a direct link between the death of patient and the gore® viabahn® vbx balloon expandable endoprosthesis.(b)(4).

• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15103273
• MDR Text Key: 296580607
• Report Number: 2017233-2022-03159
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637515
• UDI-Public: 00733132637515
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2023
• Device Model Number: BXA072902A
• Device Catalogue Number: BXA072902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Date Device Manufactured: 08/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 81 YR
• Patient Sex: Female