MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBHR080502W

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2024

Event Type  malfunction  

Event Description

It was reported to gore that on (b)(6), 2024, a patient was to be implanted with an 8 mm x 5 cm gore® viabahn® endoprosthesis with heparin bioactive surface (vsx device) to perform subclavian artery fenestration.The surgeon established two puncture sites at the brachial and femoral arteries.Firstly, he deployed an aortic endoprosthesis, then he used an adjustable bent sheath and a wall breaking balloon to break the endoprosthesis, afterwards he used a boston scientific balloon to pre-dilate.A cook 8f x 90cm long sheath was used to deliver vsx device through the fenestration.Vsx device reached target lesion and sheath was retracted, deployment knob was pulled to deploy vsx device.After pulling the cable for some time, it got stuck and deployment was failed after several attempts.The vsx was then removed from patient.It was unable to be deployed with the tip end bowing after testing it at back table.A 12f x 80cm long sheath was used and another 10mm x 2cm vsx device (vbh100202w) was used to complete the procedure successfully.After deployment, angiography showed good blood flow.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H6: code: c19: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Code: c21: the device was returned to w.L.Gore and it is under engineering evaluation.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.

Manufacturer Narrative

H6: code d15 - the primary reported device failure mode, related to an inability to deploy the device, could not be independently confirmed through evaluation of the returned device because deployment continued during evaluation.Information reported with the complaint indicates the vsx device was intended for use in conjunction with a fenestrated aortic endoprosthesis.The vsx device instructions for use (ifu) warn against deploying the device within stents or stent grafts other than another gore® viabahn® endoprosthesis to prevent potential deployment failure.Use of the vsx device in the aorta, including in conjunction with fenestrated or branched evar stent grafts, is an off-indication use of the device.However, use of the vsx device in this fenestrated aortic application can be neither confirmed nor dismissed in relation to the cause for the reported inability to deploy the device.Procedural and benchtop deployment of the device can be impacted by different factors including, but not limited to, zipper integrity and/or delivery system support or stiffness.The cause for the reported inability to deploy the device could not be established with the available information.The investigation could not confirm the cause of the reported hazardous situation nor the primary device failure mode.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18956707
• MDR Text Key: 339118277
• Report Number: 2017233-2024-04733
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VBHR080502W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 73 KG