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

Model Number	BXAL087902A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was report to gore: on (b)(6) 2023, the patient underwent treatment of an iliac artery aneurysm using a gore® viabahn® vbx balloon expandable endoprosthesis.It was reported a fully constrained vbx device stent graft separated from the delivery system catheter in the patient iliac artery.The physician stated his suspected cause of the separated stent graft is unknown.The stent was not covering any vessels.The procedure was completed with a different gore device.The patient tolerated the procedure.On (b)(6) 2023, the patient underwent reintervention to remove the constrained vbx stent graft.A snare catheter was used to retrieve the stent graft.The patient tolerated the procedure.
Additional Manufacturer Narrative
Health effect clinical code - e2402 used to capture constrained stent graft detached in the patient.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.
Additional Manufacturer Narrative
Product evaluation: the vbx device was discarded at the treating facility, and was, therefore, not available for analysis.No items, including clinical images or device photos, were available to directly evaluate product performance relative to the reported device failure mode.

• 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: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16738808
• Report Number: 2017233-2023-03863
• Device Sequence Number: 6709777
• Product Code: PRL
• UDI-Device Identifier: 00733132637676
• UDI-Public: 00733132637676
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2025
• Device Model Number: BXAL087902A
• Device Catalogue Number: BXAL087902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown