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

Model Number BXA083902A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Aneurysm (1708)

Event Date 12/06/2022

Event Type  malfunction  

Event Description

The following information was reported to gore: on (b)(6) 2022, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was intended for use in the common iliac for treatment of bilateral iliac aneurysms.During advancement of the vbx device up and over the aortic bifurcation, through a 7fr introducer sheath (manufacturer unknown) over a 0.035" guide wire (manufacturer unknown) the device had become stuck in the introducer sheath.The physician decided to use forceps to grip the delivery catheter and force the device through the introducer sheath.After the device was advanced across the lesion, deployment was initiated.However, the vbx device was unable to deploy, and the physician attempted to remove the device through the introducer sheath but met resistance.The decision was made to cut the delivery catheter and introducer sheath to enable a larger fr introducer sheath to advance over the delivery system and capture the vbx device.However, when the physician attempted to pull the vbx device through the larger sheath, the device had become dislodged.Both sheaths, delivery catheter and guide wire were removed from the patient.An 0.014" guide wire (manufacturer unknown) was advance through the dislodged vbx device and a 6mm balloon (manufacturer unknown) initiated the deployment of the device.The 6mm balloon was removed and an 8mm balloon (manufacturer unknown) completed the deployment of the vbx device across the aneurysm.The patient did not experience any adverse consequences.

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.As the facility was unsure which device was involved, an additional gore® viabahn® vbx balloon expandable endoprosthesis (b)(4), will be included in this report.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.

Manufacturer Narrative

A review of the manufacturing records for both devices indicated the device lots met all pre-release manufacturing specifications.The reported inability to deploy could not be independently confirmed, and the root cause could not be established as the device was returned with a severed dual lumen catheter and no hub assembly.The condition of the returned device did not permit evaluation of the deployment mechanism.The reported event details describe attempted removal of the vbx device through the introducer sheath.Therefore, the root cause of the dislodgment is consistent with reasonably foreseeable misuse, namely user tries to remove delivery system with stent still mounted leading to the potential for stent migration.The ifu states the following: ¿if excessive resistance is felt as the gore® viabahn® vbx balloon expandable endoprosthesis is introduced through the hemostasis valve, remove and inspect the delivery catheter for damage.¿ the ifu also states: ¿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.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
• Type of Device: 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15983280
• MDR Text Key: 306735683
• Report Number: 2017233-2022-03574
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637317
• UDI-Public: 00733132637317
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BXA083902A
• Device Catalogue Number: BXA083902A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1