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 Codes	Insufficient Device Problem Information (3190); Device Endoleak (4074)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Code c 21: a review of the manufacturing records for the device is going to be conducted.The investigation is in process.The device remains implanted and is not available for analysis.Also was implanted: plc181000/22255311, udi (b)(4).Code f28- was used to cover that the event is ongoing and the physician is monitoring the patient.Please note that the gore® excluder® conformable aaa endoprosthesis was reported separately and covered by the manufacturer report number 3007284313-2024-03326.Additional information was requested.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
On (b)(6) 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm with a gore® excluder® conformable aaa endoprosthesis and gore® excluder® aaa endoprostheses.The maximum diameter of aortic aneurysm/lesion was 56mm.The patient tolerated the procedure.On (b)(6) 2020, follow up computed tomography (ct) scan revealed that the maximum diameter of aortic aneurysm/lesion was 64mm.Additionally, on november 24, 2020, the type i endoleak was determined.No further adverse events have been reported.No treatment was required.The event is ongoing.The physician is monitoring the patient.On (b)(6) 2021, follow up computed tomography (ct) scan revealed that the maximum diameter of aortic aneurysm/lesion was 67mm.No further adverse events have been reported.
Additional Manufacturer Narrative
H.6.Code c19: a review of the manufacturing records for the devices verified that the lot met all pre-release specifications.The devices remain implanted and are not available for analysis.Also was implanted: plc181000/22255311 udi# (b)(4).Code f28- was used to cover that the event is ongoing and the physician is monitoring the patient.Please note that the gore® excluder® conformable aaa endoprosthesis was reported separately and covered by the manufacturer report number 3007284313-2024-03326.Additional information was requested.
Event or Problem Description
On (b)(6) 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm with a gore® excluder® conformable aaa endoprosthesis and gore® excluder® aaa endoprostheses.The maximum diameter of aortic aneurysm/lesion was 56mm.The patient tolerated the procedure.On (b)(6) 2020, the core lab follow up imaging revealed that the maximum diameter of aortic aneurysm/lesion was 64mm.Additionally, on (b)(6) 2020, the type ii endoleak from the proximal lumbar branches was determined.No further adverse events have been reported.No treatment was required.The event is ongoing.The physician is monitoring the patient.On (b)(6) 2021, follow up core lab scan revealed that the maximum diameter of aortic aneurysm/lesion was 67mm.No further adverse events have been reported.The information was provided from the site that the physician confirmed the type ii endoleak and that there was no increase in the aneurysm size.It was measured 56 mm.Additionally, the patient expired on (b)(6) 2021 due to the coronary thrombosis.There was no type ii endoleak noticed.The death was not device or procedure related.This report was sent as a retraction.
Additional Manufacturer Narrative
Due to the information provided that there was a type ii endoleak without aneurysm enlargement and the physician did not do any reintervention, and the patient¿s death a year after the procedure was not related to the device /procedure, this event is no longer considered reportable.This report was sent as a retraction.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19602620
• Report Number: 3013164176-2024-02114
• Device Sequence Number: 11621392
• Product Code: MIH
• UDI-Device Identifier: 00733132618736
• UDI-Public: 00733132618736
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2024

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 Expiration Date: 08/12/2023
• Device Catalogue Number: PLC181200
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 06/25/2024; 07/31/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 06/27/2024; 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• 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
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White