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

Catalog Number	BXA075901A
Medical Device Problem Codes	Collapse (1099); Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2024, the patient was implanted with a gore® excluder® aaa endoprosthesis to treat a ruptured abdominal aortic aneurysm.Gore® viabahn® vbx balloon expandable endoprosthesis (vbx devices) were implanted in the superior mesenteric artery (sma) and the right renal artery as snorkels during the procedure.The physician reported on the evening of (b)(6) 2024, that the vbx stent graft was thrombosed.Immediately, a reintervention occurred and reportedly the physician was unable to advance through the sma and vbx stent graft.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The device was not returned to gore for direct analysis.Therefore, an engineering evaluation could not be performed.The available information reported in the complaint does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.According to the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion.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, the patient was implanted with a gore® excluder® aaa endoprosthesis to treat a ruptured abdominal aortic aneurysm.Gore® viabahn® vbx balloon expandable endoprosthesis (vbx devices) were implanted in the superior mesenteric artery (sma) and the right renal artery as snorkels during the procedure.The physician reported on the evening of (b)(6) 2024, that the vbx stent graft was thrombosed.Immediately, an endovascular reintervention occurred and reportedly the physician was unable to advance through the sma and vbx stent graft.The procedure was aborted, and the patient tolerated the procedure.The physician suspected the vbx device may have thrombosed because the eye of the tiger technique was performed incorrectly, consequently the gore® excluder® aaa endoprosthesis may have compressed the vbx stent graft.The patient will continue to be monitored.None of the gore devices were explanted, and no additional gore devices were implanted.
Additional Manufacturer Narrative
Revised: b1 to adverse event and product problem.Revised: b5 additional information.Revised h6: added medical device problem code and revised investigation conclusion.Revised h10: the manufacturing records were reviewed and documented in the product history task.The device lot met all pre-release specifications.The risk management file for the vbx device was reviewed and determined to be accurate and complete.No update is required.An assessment was completed to determine if the event conclusions warrant consideration for a capa, scar, and/or fir following md179991 appendix a.It was determined that no action is required.The reported complaints of vbx device compression and thrombosis could not be independently confirmed.There were no items (e.G.Clinical images, returned vbx device) received in association with this complaint to allow evaluation of the performance of the vbx device relative to the reported failure modes.A review of manufacturing records indicated that the vbx device lots met all pre-release manufacturing specifications.According to the information provided, the physician attributed the cause of the vbx device compression and thrombosis to incorrect performance of the ¿eye of the tiger¿ surgical technique.

• 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: 19075891
• Report Number: 2017233-2024-04810
• Device Sequence Number: 17323910
• Product Code: PRL
• UDI-Device Identifier: 00733132637287
• UDI-Public: 00733132637287
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 06/18/2024

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: BXA075901A
• 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: 03/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male