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

Catalog Number	PLC201400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Coagulation Disorder (1779)
Date of Event	10/16/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: plc201200/ 26312837 udi (b)(4).The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to death.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) 2023, the patient was implanted with two gore® excluder® aaa contralateral leg endoprostheses.On (b)(6) 2023, the patient expired.It was reported the field sales associate (fsa) contacted the physician and was told the patient had a previously implanted endologix alto device implanted.Images (date and modality is not available) revealed a type i a endoleak.The cause of death was hemorrhagic shock and coagulopathy.During procedure the patient had blood loss of 20,000cc, blood products were given.The physician did not attribute the cause of death to the implanted gore devices.Fsa was not present for this procedure and was not aware that gore devices were implanted nor was he aware the patient expired.No further information is available.
Additional Manufacturer Narrative
Corrected h1/h2.
Additional Manufacturer Narrative
The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include but are not limited to death.
Additional Manufacturer Narrative
The ¿date received by manufacturer¿ field had been inadvertently entered incorrectly in this specific complaint file.The ¿date received by manufacturer" is being corrected to align with the supporting evidence available in the communication and documentation records.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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18591781
• Report Number: 3013164176-2024-01968
• Device Sequence Number: 18188433
• Product Code: MIH
• UDI-Device Identifier: 00733132618552
• UDI-Public: 00733132618552
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/02/2025

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 Expiration Date: 07/17/2026
• Device Catalogue Number: PLC201400
• 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: 01/03/2024
• Supplement Date Received by Manufacturer: 01/03/2024; 01/03/2024; 01/03/2024; 12/20/2023
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/29/2024; 03/05/2024; 03/28/2024; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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: Hospitalization; Death
• Patient Age: 83 YR
• Patient Sex: Female