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

Catalog Number	PLC121200
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, this patient underwent endovascular treatment of a zone 9 abdominal aortic aneurysm and was implanted with gore® excluder® conformable aaa endoprosthesis.Post deployment of the contralateral leg (plc121200/28678193) it was determined the right hypogastric artery had been unintentionally covered due to spasms from the right external iliac artery having been small (maximum 9mm diameter) and we couldn't see clearly.The physician ballooned the graft and when they ballooned the distal end of the right side, we ruptured the right external iliac artery just below the origin of the right internal iliac artery with a gore® molding and occlusion balloon (mob) catheter.The cause of the rupture is thought to have been due to the vessel diameter coupled with over inflation of the mob.At this time the patient¿s pressure was not stable and the treated the rupture with 2 gore® viabahn® (vbx) balloon expandable endoprosthesis and extended coverage down to the femoral head.As the patient was still unstable the physician suspected a bleed in the hypogastric artery they ligated the right hypogastric artery.The patient became stable and the procedure was concluded.Blood loss was reported to be around 5 liters however the patient was not transfused.
Additional Manufacturer Narrative
B7: patient medical history includes but is not limited to: hyperlipidemia, hypertension, coronary artery disease, history of traumatic brain injury, previous stroke.D10: patient medications include but are not limited to: cymbalta, xalatan, nasonex, cozaar, restoril, topamax, lipitor, vitamin d3voltaren, zetia, arava, claritin, zofran.H6: code 22: 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: 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.

• 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: 20562188
• Report Number: 3013164176-2024-02252
• Device Sequence Number: 18387229
• Product Code: MIH
• UDI-Device Identifier: 00733132618712
• UDI-Public: 00733132618712
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 10/29/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: PLC121200
• 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: 10/08/2024
• Initial Report FDA Received Date: 10/29/2024
• Date Device Manufactured: 05/09/2024
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 59 KG