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

Model Number	BXA095901A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
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
On (b)(6) 2022, the patient underwent a tips reduction procedure using a gore® viabahn® vbx balloon expandable endoprosthesis.The distal end of the vbx device was unsheathed and the balloon was inflated to expand the distal portion inside previously implanted viatorr stent.The physician then deflated the balloon and attempted to pull the balloon back to complete the remaining portion of the partially deployed vbx device.However, it was reported the delivery system catheter became stuck on the guidewire (amplatz wire).The physician disconnected the hub from the catheter trying to remove the delivery system from patient.The physician then pulled the guidewire and delivery system catheter out of the patient.The stent graft dislodged from the delivery system catheter and remained in its intended location partially deployed.The physician then advance a guidewire into the partially deployed vbx device.The procedure was complete by advancing a balloon and expanding the partially deployed vbx device.The device was reportedly able to be fully expanded in its intended location.No patient harm or impact was reported.
Additional Manufacturer Narrative
Engineering evaluation: the device was returned with no endoprosthesis or hub assembly present.The balloon catheter was necked and broken consistent with the application of force during reported hub disconnection in the procedure.The balloon cover appeared constrained on the proximal end with corresponding ring impressions while the appearance of the balloon cover on the distal end was consistent with partial deployment as reported.No further remarkable observations were noted with respect to the delivery system.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu) states, ¿during positioning, verify that the endoprosthesis is still centered within the marker bands and has not been dislodged.Do not deploy the endoprosthesis unless it is properly centered on the balloon and properly positioned within the target lesion.If the position of the endoprosthesis within the lesion is not optimal, it should be carefully repositioned or removed.¿ the ifu also states: ¿if needed, the delivery catheter and the sheath or guide catheter may be removed together as a unit.Excessive or abrupt force during catheter removal may damage the delivery catheter, or introducer sheath.¿.

• 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: 15955713
• Report Number: 2017233-2022-03563
• Device Sequence Number: 15104399
• Product Code: PRL
• UDI-Device Identifier: 00733132637362
• UDI-Public: 00733132637362
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 01/04/2023

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: 11/03/2024
• Device Model Number: BXA095901A
• Device Catalogue Number: BXA095901A
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 11/16/2022; 11/16/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 01/04/2023; 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown