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

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/11/2021

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.A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.Further information like lot-/serial no.And which vbx-device exactly has occluded, was requested from the study coordinator.No further information has been provided yet.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 on 2/19/24 from a retrospective study: on (b)(6) 2020, this 75 year-old patient underwent endovascular treatment for a thoracoabdominal aneurysm.The patient was treated with a bolton branch device and eight gore® viabahn® vbx balloon expandable endoprostheses (vbx-devices) to the celiac trunk (1), superior mesenteric artery (2), right renal artery (2), and left renal artery (3).The vbx devices were successfully navigated to the intended location and successfully deployed.Device catheters were successfully removed.The devices were noted as patent at the end of the procedure.The patient was noted to have a left renal artery branch occlusion on (b)(6) 2021.Reintervention, hospitalization, and/or medication were not required.The adverse event is ongoing and the outcome is unknown.

Manufacturer Narrative

H6 evaluation codes investigation findings c20 was selected because no device investigations were able to be performed.As the device remains implanted, a further investigation of the device cannot be performed.Neither clinical images enabling direct assessment of product performance, nor the device was returned for evaluation.With the information provided to gore, the cause of the reported event cannot 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.

Event Description

The following was reported to gore on 2/19/24 from a retrospective study: on (b)(6) 2020, this 75 year-old patient underwent endovascular treatment for a thoracoabdominal aneurysm.The patient was treated with a bolton branch device and eight gore® viabahn® vbx balloon expandable endoprostheses (vbx-devices) to the celiac trunk (1), superior mesenteric artery (2), right renal artery (2), and left renal artery (3).The vbx devices were successfully navigated to the intended location and successfully deployed.Device catheters were successfully removed.The devices were noted as patent at the end of the procedure.The patient was noted to have a left renal artery branch occlusion in all three vbx-devices on (b)(6) 2021.Reintervention, hospitalization, and/or medication were not required.Due to the absence of clinical signs or symptoms at that time, no intervention was required.(b)(6) 2024: new ae alert - 2104-819-014 received with term "death for unknown reason." the cause of death is unknown, and it was not suggested that the vbx devices caused or contributed to the event.

• 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: 18883939
• MDR Text Key: 337404350
• Report Number: 2017233-2024-04705
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• 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: 02/19/2024
• 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: BOLTON BRANCH DEVICE
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male