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

Catalog Number	BXA095902A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was received from a clinical study: on (b)(6) 2021, a study patient underwent a aaa procedure where a tambe device was implanted.During this procedure, gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were implanted as branch devices in the visceral arteries.At 36 month follow-up, imaging done on (b)(6) 2024, showed a wire fracture of the celiac artery side branch component.As reported in the observation report, there appeared to be two locations of fracture within the 2 most distal stent rows.The scan began distal to the left subclavian artery.As reported, all branch devices were patent, including the vbx device existing in the celiac artery.The x-ray done on the same day reports the stent fracture was visualized in the lpo view.No intervention was reported.Action taken by physician was to continue close monitoring.The patient appears to be asymptomatic.
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.H6: code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6: code b20: device remains implanted.Therefore, direct product analysis was not possible.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
H6: code b15: imaging evaluation was conducted.Report states: this complaint, received through a clinical study alert, reports strut fracture in a vbx device observed in ct imaging during follow-up imaging 36 months after implantation.No reduction in flow through the vbx device or other impact to the patient was reported in association with the reported fracture.Clinical images were provided in association with this complaint and evaluation of the images confirmed strut fracture as reported.Neither the specific timing nor mechanism of the fracture could be established with the information available, including evaluation of the images available.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20592395
• Report Number: 2017233-2024-05471
• Device Sequence Number: 6567876
• Product Code: PRL
• UDI-Device Identifier: 00733132637379
• UDI-Public: 00733132637379
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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: 06/04/2024
• Device Catalogue Number: BXA095902A
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2021
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White