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

Catalog Number BXAL085902E

Device Problem Collapse (1099)

Patient Problem Obstruction/Occlusion (2422)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.B3: as no exact event date was mentioned, (b)(6) 2023, was chosen.D6a: as no exact implant date was mentioned, (b)(6) 2021 was chosen.H3 other: as the device remains implanted, no further investigation of the device can be performed.H6 evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing records indicated the lot met all pre-release specifications.Further details were requested from the physician, but not 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

It was reported to gore that the patient underwent endovascular treatment for a stenosis of the dialysis fistula on the left brachial cephalic vein with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device).It was stated that normally the physician would use a gore® viabahn® endoprosthesis with propaten bioactive surface for such a procedure, but under the circumstances the dimensions of the vbx-device were a better fit.The original implantation date is unknown but was sometime in 2021.Earlier this year the patient re-presented with a swelling of the arm and was found to have an occluded stent that had crushed between the aortic arch and sternum.It was reported that the physician plans to place a bare metal stent to improve the flow and to realign the crushed vbx-device.

Manufacturer Narrative

Further details were received from the physician.A2 and a4 was not provided.B5 was updated accordingly as well as d6a.Imaging evaluation: investigation report: the reported primary device failure mode, related to collapse of the gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) and occlusion of the fistula, could not be independently confirmed through evaluation of the provided clinical image.The reported information indicates the endoprosthesis was crushed between the patient¿s aortic arch and sternum, but a specific event that caused the collapse was not reported.Use of the vbx device to treat outflow stenosis of a fistula is an off-indication use.The cause for the reported endoprosthesis collapse is attributed to the off-indication use of the vbx device as reported.In the instruction for use (ifu) for the gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) the following is stated: ifu statements: the vbx device ifu was reviewed with respect to the complaint detail for the applicable region and time period, and the following ifu statement was identified as related to the primary device failure mode in this complaint.Warnings: as with any balloon expandable stent, use of the gore® viabahn® vbx balloon expandable endoprosthesis in anatomy and procedures where the device is susceptible to severe external compression may result in permanent compression of the device.This can cause partial or complete device occlusion which may result in ischemia and related serious harms, potentially necessitating additional endovascular procedures or surgical intervention.H6 evaluation codes health effect - impact code f25 which was chosen in the initial report has to be removed, as it was chosen by mistake.

Event Description

It was reported to gore that the patient underwent endovascular treatment for a stenosis of the dialysis fistula on the left brachial cephalic vein with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device).It was stated that normally the physician would use a gore® viabahn® endoprosthesis with propaten bioactive surface for such a procedure, but under the circumstances the dimensions of the vbx-device were a better fit.The original implantation took place on (b)(6) 2021.Earlier this year the patient re-presented with a swelling of the arm and was found to have an occluded stent that had crushed between the aortic arch and sternum.On (b)(6) 2023 the physician relined the vbx-device with a good outcome.According to the physician the patient wasn't aware of anything that may have contributed to the event and for him the location of the endoprosthesis may have contributed to increased external pressure.

• 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: 16944253
• MDR Text Key: 315352383
• Report Number: 2017233-2023-03935
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2023
• Device Catalogue Number: BXAL085902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female