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

Catalog Number BXA115902A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/17/2023

Event Type  malfunction  

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.A review of the manufacturing records indicated the device met pre-release specifications.Engineering evaluation: the reported primary device failure concerning inability to advance the vbx device could not be independently confirmed as no items were returned for an assessment of product performance.Event details indicate resistance during advancement was encountered at the distal portion of the sheath near the flow divider of an existing implant.Unintended device interactions with the pre-existing implant may have caused or contributed to the reported inability to advance; however, the root cause of the advancement failure could not be established as the clinical circumstances that may have influenced advancement could not be confirmed.The reported withdrawal difficulty through the sheath also could not be independently confirmed without items to allow further investigation.The field reports resistance during attempted withdrawal of the delivery system catheter through the sheath.However, the root cause of the withdrawal difficulty could not be established with the available information.The reported endoprosthesis dislodgement could not be independently confirmed in the absence of items for direct analysis.The reported information indicates there was failed advancement, and the application of force as reported suggests excessive resistance was encountered.Excessive resistance during advancement is consistent with loss of stent retention to the delivery system.The ifu instructs the user to remove the delivery catheter and sheath together as a unit if excessive resistance is felt.As reported, the vbx device and the sheath were not removed as a unit.The endoprosthesis dislodged following unsheathing and attempted withdrawal.The withdrawal attempt is consistent with withdrawal through the sheath as it was indicated the procedure was completed with removal of the sheath after dislodgement was observed.The ifu contains instructions concerning device withdrawal and also warns against the retraction of a fully introduced stent-graft into the sheath to prevent dislocation.Therefore, the root cause of the dislodgement of the stent-graft is consistent with unintended use error as reported (i.E., user cannot advance delivery system into patient and user tries to remove the delivery system with stent still mounted leading to the potential for stent migration).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: ¿using fluoroscopic guidance, advance the delivery catheter over the guidewire via the angiographic sheath.Advance cautiously, especially if resistance is felt.If excessive resistance is felt, remove the delivery catheter and sheath together as a unit.¿ 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.¿ 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 Description

On (b)(6), 2023, the patient underwent treatment for a type 1b endoleak in an existing medtronic endurant stent graft using a 11 mm x 59 mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) in the internal component.It was reported the physician was performing a unilateral deployment technique where a 10f gore® dryseal flex introducer sheath was placed in the iliac branch endoprosthesis (ibe) gate.Reportedly, during advancement, the vbx device delivery system tracked through the sheath without issue until it met resistance in the distal portion of the sheath near the flow divider.Despite applying force, it would not advance further.An attempt was made to retract the delivery system catheter back through the sheath but there was too much resistance.The decision was then made to unsheathe the stent-graft.When they tried to retract everything, the vbx device stent-graft dislodged from the balloon, and was free floating in the ibe inside the patient.The procedure was completed by removing the 10f sheath, and also losing wire.A new wire and a 16f sheath were advanced deeper in the ibe gate.Another vbx device was advanced over the flow divider and deployed in the internal iliac, distal to the free floating device.The undeployed stent-graft remains pushed up against the arterial wall between two gore stents, the gore® excluder® aaa endoprosthesis (iliac extender) and the vbx device.Final angiography showed the endoleak was successfully excluded.It was reported there was no impact to the patient.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17852692
• MDR Text Key: 324708540
• Report Number: 2017233-2023-04315
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637744
• UDI-Public: 00733132637744
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA115902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2023
• Date Device Manufactured: 04/08/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 83 YR