MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Catalog Number BXA071501E

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.(b)(4).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 publication was reviewed: eilenberg, w., panuccio, g., rohlffs, f., eleshra, a.S., heidemann, f.And kölbel, t., 2021.Bail-out technique to detach a locked viabahn endoprosthesis in branched thoracic endovascular aortic repair.Journal of vascular surgery cases, innovations and techniques, 7(4), pp.593-596.It was reported that a patient presented with a 5.8 cm thoracoabdominal aortic aneurysm following partial arch treatment.The patient was treated with a branched arch endograft with one retrograde branch to the left subclavian artery.A gore® viabahn® endoprosthesis was used as bridging covered stent to the left subclavian artery.During implantation, the deployment line did not detach and the delivery catheter could not be removed using the built-in mechanisms.The physician was able to modify another device and remove the deployment line using a balloon fixation.

Manufacturer Narrative

The information reported in the literature indicates a potential device malfunction, related to the deployment line not releasing from the endoprosthesis after successful deployment, has occurred.Additional information was requested multiple times; however, the following information was not reported to gore: unique device identification; clinical images enabling direct assessment of product performance, or product.The information provided to gore cannot be connected to a specific device; therefore, this investigation is complete.Without a lot number or device serial number, the manufacturing date and/or production details cannot be determined.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.D12/d1103: according to the gore® viabahn® endoprosthesis instructions for use (ifu), w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications other than the endovascular grafting of peripheral arteries.Other devices may interfere with the deployment of the gore® viabahn® endoprosthesis resulting in deployment failure or other device malfunction.Additionally, the ifu indicates that possible adverse events and complications that may occur with the use of the device or in any endovascular procedure and require intervention include, but are not limited to: deployment failure.

Event Description

The following publication was reviewed: eilenberg, w., panuccio, g., rohlffs, f., eleshra, a.S., heidemann, f.And kölbel, t., 2021.Bail-out technique to detach a locked viabahn endoprosthesis in branched thoracic endovascular aortic repair.Journal of vascular surgery cases, innovations and techniques, 7(4), pp.593-596.Published online july 1, 2021.It was reported that a patient presented with a 5.8 cm thoracoabdominal aortic aneurysm following partial arch treatment.The patient was treated with a branched arch endograft with one retrograde branch to the left subclavian artery (lsa).It was stated that after deployment of a gore® viabahn® endoprosthesis as a bridging covered stent to the lsa, the deployment line of the device did not detach and the delivery catheter could not be removed.With the use of a physician-modified sidehole catheter 5f lind (100 cm 5f lind catheter; cordis corporation, a cardinal health company, milpitas, calif) and balloon fixation, the pulling line could be detached without displacement of the viabahn covered stent with an excellent angiographic and clinical result.

Manufacturer Narrative

Attachment added.G4: pma/510(k)number update.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• 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: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15368567
• MDR Text Key: 299357603
• Report Number: 2017233-2022-03296
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA071501E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female