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

Catalog Number BXA085902E

Device Problems Fluid/Blood Leak (1250); Malposition of Device (2616); Device Handling Problem (3265)

Event Date 10/06/2022

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the study number with codes for the hospital and patient.H3 other code: as the device remains implanted, no further investigation can be performed.Neither clinical images enabling direct assessment of product performance, nor the device was returned for evaluation.H6 evaluation codes investigation results c19 refers to the product history review.A review of the manufacturing records indicated the device met pre-release specifications.With the available information, we are unable to determine the cause of this incident and assign a root cause.The physician stated that this was a complex procedure and it seems that a too short vbx device was implanted and not positioned correctly.Cbas® heparin surface incorporates carmeda-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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: endoleak and/or endotension.The ifu was reviewed and the following statement was found to be applicable: wherever appropriate, it is recommended that the endoprosthesis overlap the healthy native vessel at least 1 cm beyond the proximal and distal margins of the lesion when treating stenotic or occlusive lesions and preferably at least 2 cm beyond the proximal and distal margins of the lesion when treating aneurysmal lesions.Endoprosthesis foreshortening should be taken into account to achieve the recommended lesion coverage.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 was reported to gore from a retrospective study: on (b)(6), 2019, this 71-year-old patient underwent endovascular treatment for a thoracoabdominal aneurysm in the descending thoracic aorta.Patient was treated with a cook custom branch device and six other devices from other manufacturers were used in the right- and left renal arteries and the superior mesenteric artery.In a planned stage two of the procedure on (b)(6), 2019, one gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device) was implanted in the celiac trunk.The vbx-device was successfully navigated to the intended location and successfully deployed.Device catheters were successfully removed.The device was noted as patent at the end of the procedure.This patient was noted to have multiple endoleaks reported on (b)(6), 2019, and (b)(6), 2020.This resulted in hospitalization and surgical reintervention.Endovascular reinterventions in the celiac trunk occurred on august 14, 2019, in which a bentley begraft was placed and (b)(6), 2020, in which pta was performed only.The device was noted to be patent at the end of all these reinterventions (mpdcase-(b)(4) your reference number (b)(4)).On (b)(6), 2022, a new vbx-device was implanted in the celiac trunk branch due to a type ii endoleak.Reportedly, it was a very complicated case and it seems that a too short vbx-device was implanted and not positioned correctly and therefore at the end of the procedure, a type ic endoleak was noticed, which required treatment.On (b)(6), 2022, a reintervention was performed and an getinge advanta v12 device implanted.The device was noted to be patent at the end of the reintervention and the type ic endoleak was resolved at the end of the procedure.

• 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: 18620553
• MDR Text Key: 334257368
• Report Number: 2017233-2024-04581
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: NO
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA085902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2022
• 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: COOK CUSTOM BRANCH DEVICE, GETINGE ADVANTA V12.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male