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

Catalog Number	BXB073902A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient underwent treatment for a calcified superior mesenteric artery (sma) using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).It was reported during the procedure, the physician encountered difficulty while attempting to advance the vbx device over an amplatz guidewire (size unknown) and through a 7fr terumo sheath to reach the target treatment site.Due to severe stenosis of the sma, the target area could not be reached.The physician attempted to withdraw the vbx device through the sheath and it was observed that the back end of the device got caught on the sheath and the stent dislodged from the balloon in the aorta, resulting in the procedure being aborted.Subsequently, the physician performed a groin cutdown to retrieve the dislodged stent.The procedure was then successfully completed with a replacement vbx device.The patient did not experience any additional adverse consequences.
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: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Engineering evaluation: the primary reported failure mode, concerning an inability to advance the vbx device to the intended target treatment location, could not independently confirmed.No items were returned for an assessment of product performance relative to the reported complications.However, the reported information indicates the advancement failure was attributed to severe stenosis.Therefore, the root cause is consistent with patient related condition as reported.The reported stent dislodgement could not be independently confirmed; however, event details indicate the endoprosthesis was fully introduced outside of the sheath and subsequently retracted as it was observed ¿the back end of the device got caught on the sheath¿ prior to the dislodgement.Therefore, the root cause of the stent dislodgment 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 of the endoprosthesis.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) was reviewed with respect to the details provided in the complaint.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 sheath can cause dislocation and / or damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.The ifu also states: 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.After removal, do not reuse the gore® viabahn® vbx balloon expandable endoprosthesis or introducer sheath.¿ 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.

• 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: jazmin dela rosa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21947085
• Report Number: 2017233-2025-06133
• Device Sequence Number: 12970762
• Product Code: PRL
• UDI-Device Identifier: 00733132658640
• UDI-Public: (01)00733132658640(17)271112
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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
• Report Date (Section B): 05/01/2025

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 Catalogue Number: BXB073902A
• 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: 04/11/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown