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

Device Problems Complete Blockage (1094); Obstruction of Flow (2423)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 04/24/2023

Event Type  Injury  

Event Description

The following was reported to gore on 1/25/2024 from a retrospective study: on (b)(6) 2021, this 81-year-old male underwent treatment for a juxtarenal aneurysm.A jotec custom made device was used and four gore® viabahn® vbx balloon expandable endoprosthesis devices were implanted successfully in the celiac trunk, superior mesenteric artery, left renal artery, and right renal artery.The vbx-devices were successfully navigated to the intended locations and successfully deployed.Device catheters were successfully removed.The devices were noted as patent at the end of the procedure.On (b)(6) 2023, the patient was noted to have an occluded vbx-device in the celiac trunk, but blood supply was made possible by the collaterals.It is noted that treatment was not required for this adverse event.

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., possible root cause and if images are available were 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 1/25/24 from a retrospective study: on (b)(6) 2021, this 81-year-old male underwent treatment for a juxtarenal aneurysm.A jotec custom made device was used and four gore® viabahn® vbx balloon expandable endoprosthesis devices (vbx device) were implanted successfully in the celiac trunk, superior mesenteric artery, left renal artery, and right renal artery.The vbx-devices were successfully navigated to the intended locations and successfully deployed.Device catheters were successfully removed.The devices were noted as patent at the end of the procedure.Reportedly the vbx device in the celiac trunk (ct) was implanted on (b)(6) 2021 as an external branch device and pre-planning cta showed a pre-existing stenosis of the ct.It remains unknown if ct pre-dilation prior to vbx implantation was performed.The cta dated 04-aug-2022 and 13-oct-2022 showed stenosis of the ct <25%.It was noted that anticoagulation therapy was resumed on (b)(6) 2022 and antiplatelet/ anticoagulation therapy has not been changed since then.On (b)(6) 2023, the patient was noted to have an occluded vbx-device in the celiac trunk, but blood supply was made possible by the collaterals.It is noted that treatment was not required for this adverse event.

Manufacturer Narrative

B5 describe event or problem was updated.Further information like lot-/serial no., possible root cause and if images are available were requested from the study coordinator.The study coordinator provided the lot-/serial no.And stated that the root cause for the occlusion is unknown.There is no possible cause noted in the electronic patient record.H6 evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing records indicated the device met pre-release specifications.With the information provided to gore, we are unable to determine the cause of this incident and assign a root cause.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.

• 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: 18684519
• MDR Text Key: 335198442
• Report Number: 2017233-2024-04619
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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: 04/08/2024
• 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: JOTEC CUSTOM MADE DEVICE
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 94 KG