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

Catalog Number BXA071902E

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/04/2021

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2020, the patient underwent endovascular treatment for a stenosed celiac artery with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device).A vbx-device was implanted to treat the lesion in the celiac artery.The vbx-device was navigated to its intended location and deployed without issues.Pre- and distal post-dilation was performed.At the end of the procedure the vbx-device was patent.The patient tolerated the procedure.On (b)(6) 2021, a thrombosis of the vbx-device in the celiac trunk occurred.The adverse event is not recovered / resolved, and no treatment is required.

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.A review of the manufacturing- and heparin-coating records indicated the lot met all pre-release specifications.The physician stated that no treatment is required, as the patient is asymptomatic, and the superior mesenteric artery (sma) is patent and with adequate collateral circulation to compensate.The physician stated that the root cause for the thrombosis is unknown and he don't know if the thrombosis is related to patient conditions and/or comorbidities.The ostium of the artery had severe calcification, which could cause compression on the stent.With the provided information to gore, the cause of the reported event could not be established.In the instruction for use for the gore® viabahn® vbx balloon expandable endoprosthesis the following is stated: 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: occlusion (thrombosis and/or stenosis) of endoprosthesis or vessel.Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15691649
• MDR Text Key: 302611402
• Report Number: 2017233-2022-03434
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2020
• Device Catalogue Number: BXA071902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 88 KG