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 Codes	Material Rupture (1546); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
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.H6 - c21: results pending completion of investigation.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) 2025, a patient underwent treatment for an unknown disease/etiology in the iliac artery where a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was used.It was reported during the procedure, a 7mm x 39mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was advanced over a 0.035¿ guidewire (brand unknown) through an introducer sheath (brand unknown) to the target treatment site in the iliac artery.The vessel had ben pre-dilated, and no resistance was noted during device advancement.No previously implanted devices were encountered, although calcification was noted.During initial deployment, the balloon ruptured and it separated from the vbx delivery system, becoming dislodged within the patient.As a result, post-dilatation was performed since the vbx device had not reached its nominal pressure.It remains unknown whether post-dilatation occurred before or after retrieval of the ruptured balloon.The timing of the physician's snare attempt to retrieve the ruptured balloon is also unknown.After this attempt failed, a cutdown procedure was performed to retrieve the ruptured balloon within the patient.The vbx device had already been deployed at the time of balloon rupture.Although the device did not fully expand, the device successfully reached the target treatment area, and the procedure was completed without complications.The physician is unable to determine the cause of the balloon rupture and device dislodgement.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
Section h6 updated to reflect completion of investigation.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, related to a balloon rupture during inflation, was consistent with the engineering evaluation findings of a circumferential tear in the balloon.The root cause of the primary reported failure could not be established with the available information.The secondary reported failure mode, related to balloon dislodgement, was consistent with the engineering evaluation findings of a complete separation of the distal and proximal portions of the balloon.The root cause of the secondary reported failure mode could not be established with the available information.The returned device also exhibited a broken delivery catheter shaft.The cause for this damage could not be determined, but it is consistent with damage resulting from the reported inability to fully deploy/inflate, an unknown device interaction during withdrawal, or manipulation of the device either during or after the procedure.

• 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: 23074001
• Report Number: 2017233-2025-06615
• Device Sequence Number: 9738402
• Product Code: PRL
• UDI-Device Identifier: 00733132658640
• UDI-Public: (01)00733132658640(17)271114
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 10/21/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2024
• 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; Hospitalization
• Patient Sex: Unknown