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

Catalog Number BXAL087901J

Device Problem Positioning Failure (1158)

Event Date 07/12/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, this patient underwent a 1-debranching tevar for an thoracic (arch) aortic aneurysm using gore® tag® conformable thoracic stent grafts with active control system (ctag acs).Two ctag acs were placed as planned without any problems.When closing the puncture site (left femoral artery [fa]), the blood vessel was injured by perclose proglide and retrograde dissection occurred (it extended into the aorta).To prevent further extension of the dissection, two aortic extender components of gore® excluder® aaa endoprosthesis were placed in the abdominal aorta.Four bare-metal stents (e-luminexx) were additionally placed from the left common iliac artery (cia) to fa and the puncture site was repaired surgically.There was still blood flow into the false lumen from the origin of left common iliac artery, thus, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was placed in the left cia, but it could not close the entry.Therefore, an additional aortic extender was placed in the aortic terminal and two additional vbx devices were attempted to be placed in bilateral cia with a kissing balloon technique; however, the physician deployed the vbxs without noticing that the guidewire of the left side was outside of the aortic extender.This resulted in vbx deployment outside the aortic extender, and unintentional coverage of the left cia.The dissection was resolved but blood flow in the left side decreased, thus, a femorofemoral arterial bypass was constructed.It was confirmed that the patient was able to move his legs and tolerated the procedure.

Manufacturer Narrative

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

Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.The device remains in the patient.Consequently, a direct product analysis was not possible.Cause of the reported event cannot be established based on evaluation of the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17472085
• MDR Text Key: 320532200
• Report Number: 2017233-2023-04173
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXAL087901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2022
• 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): Hospitalization; Other
• Patient Age: 81 YR
• Patient Sex: Male