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

Device Problem Fluid/Blood Leak (1250)

Event Date 07/10/2019

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.Product history review: a review of the manufacturing records for the device could not be conducted because the serial/lot number was not provided yet.H3: other code: as the device remains implanted, a further investigation of the device cannot be conducted.Further details were requested from the study coordinator such as serial no.And possible root causes.Until now no further information was provided.Cbas® 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.

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 one gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device) to the celiac trunk.Five other devices from other manufacturers were also used in other arteries.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 july 7, 2019; (b)(6) 2022; and (b)(6) 2023.This resulted in prolonged hospitalization and surgical reintervention.Endovascular reinterventions in the celiac trunk occurred on (b)(6) 2019, in which a bentley begraft was placed; (b)(6) 2020, in which pta was performed only; and (b)(6) 2022 in which an advanta v12 was placed.During the (b)(6) 2022, an attempt was made to use vbx-device, but it did not fit through the introducer.The device was noted to be patent at the end of all these reinterventions.

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 (b)(6) 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.

Manufacturer Narrative

C20 was selected because no device investigations were able to be performed as no further information was able to be obtained from the study coordinator and we did not receive the device back for evaluation.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 b3 date of event was updated.B5 describe event or problem was updated.

• 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: 18029109
• MDR Text Key: 326845868
• Report Number: 2017233-2023-04363
• 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,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• 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: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: BENTLEY BEGRAFT, ADVANTA V12
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 104 KG