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

Catalog Number	BXB082901A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
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.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
The following information was reported to gore: on (b)(6) 2024, reduced profile gore® viabahn® vbx balloon expandable endoprosthesis (vbx stent grafts) were implanted in the renal artery, superior mesenteric artery (sma), and the celiac artery with a cook fenestrated aortic graft to treat an abdominal aortic aneurysm (aaa) using the physician modified endograft (pmeg) technique.The vbx stent grafts were implanted into the renal artery and sma without difficulty.Reportedly, the procedure presented a challenge for the physician with the approached angle accessed from the brachial artery; through a cook fenestrated aortic graft; to the implant site of the celiac artery.The vbx stent graft was advanced over a 0.035¿ cook rosenwire through a 7.5 f tourguide steerable sheath without difficulty.First with the introducer sheath a quarter of the way into the celiac artery the vessel was ballooned.It was noted, the physician withdrew the vbx device delivery catheter slightly into the introducer sheath and at that time the vbx stent graft dislodged in the vessel off of the catheter.The physician reportedly removed the vbx device delivery catheter without difficulty and was able to snare the vbx stent graft out of the patient.An additional reduced profile vbx stent graft was then implanted to the target site, and the procedure was successfully completed.There were no consequences or impact to the patient.
Additional Manufacturer Narrative
A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Investigation conclusions: the risk management file for the gore® viabahn® vbx balloon expandable endoprosthesis was reviewed and determined to be accurate and complete in relation to the complaint and associated investigation findings.No update is required.An assessment was completed to determine if the findings warrant consideration for a capa, scar, and/or fir following it was determined that no action is required.The reported primary device failure mode of endoprosthesis dislodgement could not be independently confirmed as no items were returned for an assessment of product performance.However, the field reported the physician withdrew the vbx device delivery catheter slightly into the introducer sheath, and at that time, the vbx stent graft dislodged in the vessel off of the catheter.Therefore, the root cause of the stent dislodgement 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 dislodgement.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.

• 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: amy mckeown ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19532747
• Report Number: 2017233-2024-05036
• Device Sequence Number: 12683011
• Product Code: PRL
• UDI-Device Identifier: 00733132658695
• UDI-Public: 00733132658695
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 09/16/2024

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: BXB082901A
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• 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