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

Catalog Number	PLC181200
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: gore® excluder® aaa endoprosthesis - sn (b)(6), stent graft contralateral leg - (b)(6).Gore® excluder® aaa endoprosthesis - sn (b)(6), stent graft contralateral leg - sn (b)(6).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
It was reported that on (b)(6) 2024, a patient was treated with a gore® excluder® conformable aaa endoprosthesis with active control system.On an unknown subsequent date, the patient presented with cranial displacement of the implanted devices resulting in the complete coverage of the renal arteries.All devices were explanted.
Additional Manufacturer Narrative
Medwatch#: 3013164176-2024-02083 was sent in error.Additional information was received on august 15, 2024, that intra-procedural imaging demonstrated that only the gore® excluder® conformable aaa endoprosthesis (trunk, sn: (b)(6), catalog: cxt231412e) has migrated retrograde after all devices have been implanted.However, it was required to explant the present gore® excluder® aaa endoprosthesis contralateral leg due to the migration of the cxt device to which it was connected, which is reflected in the annex f coding.Nevertheless, based on the additional information, no allegation against the gore® excluder® aaa endoprosthesis contralateral leg was reported.Therefore, the available information no longer meets the criteria of a reportable incident related to the excluder® aaa endoprosthesis contralateral leg and this medwatch will be retracted.
Event or Problem Description
It was reported that on (b)(6) 2024, a patient was treated with a gore® excluder® conformable aaa endoprosthesis with active control system and a gore® excluder® aaa endoprosthesis.Immediately following the procedure, the patient presented with cranial displacement of the trunk ipsilateral leg resulting in the complete coverage of the renal arteries.The cause of the displacement is unknown.All implanted devices were explanted.

• 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: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19391775
• Report Number: 3013164176-2024-02083
• Device Sequence Number: 7799897
• Product Code: MIH
• UDI-Device Identifier: 00733132618736
• UDI-Public: 00733132618736
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: PLC181200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown