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

Catalog Number	BXBL082902A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was reported to gore: on an unknown date, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was intended for use in an unknown location for unknown etiology.The physician reported the vbx device came off the balloon at an unknown time during the procedure.The procedure was successfully completed.There were no consequences or impact to the patient.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the device met pre-release specifications.The device was not returned to gore for direct analysis.Therefore, an engineering evaluation could not be performed.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) 2024, a reduced profile gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was implanted in the renal artery with a cook fenestrated aortic graft to treat an abdominal aortic aneurysm (aaa).Reportedly, the procedure presented a challenge for the physician with the approached angle accessed from the brachial artery; through a cook fenestrated aortic graft; to the implant site of the renal artery.The vbx device was advanced over a 0.035¿ terumo advantage glidewire through a 7.5 f destino steerable sheath without difficulty.It was noted the introducer sheath was parked at the opening of the renal artery and the vbx device was then advanced only on the guidewire.The physician needed to reposition the vbx device and to do so withdrew the vbx device delivery catheter back slightly into the introducer sheath.Consequently, the vbx stent graft came off of the delivery catheter and dislodged.The physician reportedly removed the vbx device delivery catheter without difficulty and was able to use a pta balloon to implant the vbx stent graft where it dislodged.There was no branch vessel coverage.An additional reduced profile vbx stent graft was then implanted to the target site, and the procedure was successfully completed.There were no consequences or impact to the patient.
Additional Manufacturer Narrative
Revised b5 additional information.Revised h6: investigation conclusions.Additional information to h10: the risk management file for the gore® viabahn® vbx balloon expandable endoprosthesis was reviewed and determined to be accurate and complete in relation to the complaint and associated investigation findings.No update is required.An assessment was completed to determine if the findings warrant consideration for a capa, scar, and/or fir following md179991.It was determined that no action is required.The reported primary device failure mode of endoprosthesis dislodgement could not be independently confirmed as no items were returned for an assessment of product performance.Event details indicate the stent-graft became dislodged from the delivery catheter following the physician¿s attempt to withdraw the vbx device back into the introducer sheath for repositioning.Therefore, the root cause of the dislodgement is consistent with unintended use error as reported, specifically user tries to remove delivery system with stent still mounted.The ifu contains instructions concerning device withdrawal and warns against the retraction of a fully introduced stent-graft into the sheath to prevent dislocation and/or dislodgement.The ifu instructs the user to withdraw the endoprosthesis close to the sheath to allow removal in tandem if withdrawal prior to deployment is necessary.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail, and there are applicable statements.The ifu states the following: ¿do not withdraw the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath can cause dislocation and/or dislodgement and damage to the endoprosthesis, premature deployment, deployment failure, and/or catheter separation which may result in vessel damage and/or ischemia, potentially requiring surgical intervention.If removal prior to deployment is necessary, withdraw the gore® viabahn® vbx balloon expandable endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® vbx balloon expandable endoprosthesis and introducer sheath can then be removed in tandem.¿.

• 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: 19110641
• Report Number: 2017233-2024-04825
• Device Sequence Number: 8359785
• Product Code: PRL
• UDI-Device Identifier: 00733132658596
• UDI-Public: 00733132658596
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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 Catalogue Number: BXBL082902A
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2023
• 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: Unknown