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

Catalog Number	PLC231000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6)2024, this patient underwent endovascular treatment for a zone 9 abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.Post implant of the devices the physician performed angioplasty using a gore® molding & occlusion balloon catheter.During ballooning of the larger branch artery, extravasation was seen and a closer look determined a rupture of the common iliac artery within the plc231000/(b)(6).The rupture was believed to have been caused by re-ballooning of the distal end of the plc231000/(b)(6), as good distal seal of this device had not been achieved initially.An additional plc121400/lot # unknown was implanted to treat the ruptured area and extended coverage distally, intentionally covering the internal iliac artery, down into the external iliac artery.Final run showed everything looked great.It was reported that the additional ballooning of the mob 37(lot # unk, hospital inventory) within the plc231000/(b)(6) may have caused the rupture of the iliac artery; however, no over inflation of the balloon was reported by the gore associate supporting the case was reported.The patient tolerated the procedure.Later this same day the physician reported he plans to go back in as the patient has an occluded limb (plc121400(lot #unk).Doctor reports the aneurysm sac and iliac artery had a lot of thombus which he believes embolized and caused the limb to occlude.
Additional Manufacturer Narrative
The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoprosthesis: occlusion, occlusion of device or native vessel.Rupture.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
B4, h6: additional information.
Event or Problem Description
Later this same day (b)(6) 2024) the physician re-intervened on the patient.It was determined that the patient did not have blood flow in his left leg and he was brought back to the operating room.A femoral to femoral bypass, and ebolectomy was performed on the left side; and bi-lateral fasciotomies from the knee down on were performed on both legs.The patient tolerated the procedure.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18937407
• Report Number: 3013164176-2024-02018
• Device Sequence Number: 6827241
• Product Code: MIH
• UDI-Device Identifier: 00733132618576
• UDI-Public: 00733132618576
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• 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): 03/20/2024

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?: No
• Device Expiration Date: 05/06/2026
• Device Catalogue Number: PLC231000
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 73 YR
• Patient Sex: Male