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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
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) 2023, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was intended for use in the right common iliac artery for peripheral arterial disease.It was noted that the vbx device dislodged during attempted deployment with no stent expansion.The physician was able to retract the vbx device delivery catheter without difficulty.Then, the physician was able to use a small balloon (unknown manufacturer/size) to expand and deploy the vbx device successfully.There were no adverse consequences or impact to the patient.
Additional Manufacturer Narrative
Returned device evaluation: the primary reported complication of endoprosthesis dislodgement was confirmed.According to the information provided, the endoprosthesis remained implanted.The returned vbx device delivery system associated with the complaint showed no indication of inflation of the balloon.Bunching and folding of the balloon cover at the distal tip is consistent with endoprosthesis dislodgement from the distal tip of the delivery catheter.The mechanism of the endoprosthesis dislodgement cannot be established, though observations on the returned vbx device are consistent with endoprosthesis dislodgement due to a potential device interaction during advancement positioning.

• 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: amy mckeown ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16717994
• Report Number: 2017233-2023-03852
• Device Sequence Number: 7237369
• Product Code: PRL
• UDI-Device Identifier: 00733132637676
• UDI-Public: 00733132637676
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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: 10/19/2023
• Device Model Number: BXAL087902A
• Device Catalogue Number: BXAL087902A
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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 Sex: Female