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

Model Number	BXA063901A
Medical Device Problem Codes	Material Separation (1562); Separation Problem (4043)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2022, a vbx device was intended for use in the renal artery as a physician modified graft during treatment of an aortic aneurysm.After gaining access through the groin, the physician advanced the vbx device through a 7fr tour guide sheath, over a 0.035" guide wire (manufacturer unknown) and the vbx device was successfully delivered into the renal artery as a physician modified graft through a cook aortic device.Upon removal of the delivery catheter, it was noticed the distal balloon cover had become detached on one side and appeared to be inverted.An angiogram was performed and device verified to be in place with full expansion.The patient did not experience any adverse consequences.2203-a:-other (balloon cover detached during catheter withdrawal).
Additional Manufacturer Narrative
A review of the manufacturing records indicated the device lots met all pre-release manufacturing specifications.Engineering evaluation: the reported primary device failure mode concerning balloon cover detachment was confirmed during device evaluation.The event details state the vbx device was used with a physician-modified aortic main body device.Further details on the nature of the modification were unknown, and the impact of the modification on device interaction could not be independently assessed.However, observations of the returned device demonstrated a longitudinal cut of the returned balloon and balloon cover indicating a possible unintended interaction with the aortic endograft or another device or accessory during the procedure that compromised balloon cover integrity.Balloon cover material remnants observed at the proximal bond location suggested material rather than bond failure.However, this investigation could not establish the root cause of the material failure and the subsequent balloon cover detachment with the available information.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
• Common Device Name: 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: 15513457
• Report Number: 2017233-2022-03366
• Device Sequence Number: 5242902
• Product Code: PRL
• UDI-Device Identifier: 00733132637188
• UDI-Public: 00733132637188
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2025
• Device Model Number: BXA063901A
• Device Catalogue Number: BXA063901A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male