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

Catalog Number	BXB072902A
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: removed code c21 under investigation findings.H6: removed code d15 and added codes d1002 and d1102 under investigation conclusions.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.The device remains implanted and was, therefore, not available for direct analysis.Clinical images were returned for evaluation.The reported primary failure mode, related to an inability to advance the catheter through a previously implanted stent, could not be confirmed.The imaging evaluation of the available clinical item confirmed the presence of the vbx endoprosthesis within a non-gore aortic implanted device.As reported by the physician, it was determined that the suprarenal strut of the previously implanted stent was in the way and needed to be ballooned open further to allow the vbx catheter to cross into the target site.Therefore, the root cause of the reported primary failure mode can be attributed to the procedure.The reported secondary failure mode, related to stent dislodgement, is consistent with the findings from the imaging evaluation of the available clinical item.The imaging evaluation confirmed the presence of the vbx endoprosthesis within a non-gore aortic implanted device.The imaging evaluation also noted that the stent appeared to be off the delivery catheter but did not appear to be implanted within any visceral vessel.As reported, the physician did not observe any damage to the vbx catheter when it was initially removed to balloon open the previously implanted stent, so the same vbx catheter was reintroduced.Per the device instructions for use (ifu), the device should not be reused after removal.Upon re-entry of the vbx device into the left renal artery, resistance was met and some force was used while attempting to advance the device; the stent then dislodged from the catheter.Per the ifu, the device should be removed if excessive resistance is felt.Therefore, the root cause of the reported secondary failure mode can be attributed to the reasonably foreseeable misuses of reusing a previously introduced device and the user continuing to advance the delivery system after meeting excessive resistance.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu) was reviewed with respect to the details provided in the complaint.The ifu includes the following warning: ¿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.¿ the ifu also includes the following note: ¿using high-resolution fluoroscopic guidance, advance the delivery catheter over the guidewire via the introducer sheath.Advance cautiously, especially if resistance is felt.If excessive resistance is felt, remove the delivery catheter and introducer sheath together as described below (step 7; note).¿.
Event or Problem Description
The following was reported to gore: on (b)(6) 2024, the patient underwent treatment for a previously placed pmeg cook aaa stent graft where it had an aneurysm that lead to an endoleak in the aorta, advancing into the left renal.A reduced profile gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was used.It was reported the physician did not reach the target treatment area as the vbx catheter would not cross into the left renal artery.A cookmedical 6 fr ansel sheath and cookmedical rosen guidewire were used with an access site of the right groin.The physician felt the vbx device got caught on something while attempting to advance, a pop forward of the vbx device.They noticed the cook stent graft was in the way and it needed to be ballooned a bit to open it up.The vbx device was removed and ballooned the orifice of the left renal.At this time, the vbx catheter did not appear to be damaged so the physician reintroduced the vbx device back into the patient.When advancing the vbx device, they came across some resistance, some force was used while attempting to advance the vbx device.The vbx device dislodged from the catheter when advancing into the renal.The physician used an aortic cuff to smash the vbx device against the preexisting cook stent graft.The procedure was completed by cannulating and stenting the visceral vessels.It was reported there was no impact to the patient.
Additional Manufacturer Narrative
H6 code c19: a review of the manufacturing records indicated the device met pre-release specifications.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.
Additional Manufacturer Narrative
Removed: the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu) was reviewed with respect to the details provided in the complaint.The ifu includes the following warning: "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." added: the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu) was reviewed with respect to the details provided in the complaint.The ifu includes the following warning: "after removal, do not reuse the gore® viabahn® vbx balloon expandable endoprosthesis or introducer sheath.".

• 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: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20697078
• Report Number: 2017233-2024-05509
• Device Sequence Number: 6583228
• Product Code: PRL
• UDI-Device Identifier: 00733132658626
• UDI-Public: 00733132658626
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2024

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: BXB072902A
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 11/22/2024; Not provided
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 11/22/2024; 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2024
• 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
• Patient Sex: Unknown