MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER®AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number PLA280300J

Device Problem No Apparent Adverse Event (3189)

Patient Problem Aneurysm (1708)

Event Date 06/25/2022

Event Type  Death  

Manufacturer Narrative

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) 2022, the patient underwent endovascular treatment of an abdominal aortic aneurysm using two afx stent graft system devices.During procedure, afx2 y-shape stent graft was inserted from a right access.During deployment of a contralateral leg, the stent graft was placed to the contralateral side due to excessive pull of contralateral wire.Afx vela cuff extension was implanted, then, the attempt to remove the delivery catheter was made.However, the delivery catheter caught on the cuff and the cuff moved down about 20 mm.Also, the delivery catheter caught on bifurcation of the y-shape stent graft, and the stent of the y-shaped stent bifurcation was deformed.To treat the migration of the cuff, additionally, gore® excluder® aaa endoprosthesis, an aortic extender, was implanted proximally.The contralateral side (right leg) was stenotic due to the excessive pull of the contralateral wire.Additionally gore® viabahn® vbx balloon expandable endoprosthesis was implanted at the stenotic area.Other company's bare metal stent was implanted as both external iliac arteries were in poor condition with dissection and thrombus.On (b)(6) 2022, the patient expired due to multiple organ failure.The physician stated that the cause of death was, multiple organ failure.The patient had many proximal thrombi, which may have caused thromboembolism.Because the patient had many proximal thrombi, he selected afx devices, which can seal by expansion of the graft by blood flow, not other devices, which can seal by expansion by the force of the stent.However, the tortuosity and vascular condition of the right common iliac artery made it difficult to place the y-shape stent graft.Considering that this affected the placement of the cuff extension, he should have used other company's stent grafts.No information was available on treatment after the onset of multiple organ failure.

• Brand Name: GORE® EXCLUDER®AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15796734
• MDR Text Key: 303628286
• Report Number: 3013164176-2022-01539
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PLA280300J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2022
• 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): Death
• Patient Age: 97 YR
• Patient Sex: Male