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

Model Number	RMT231216
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Location of the explant is unknown.Preliminary results are not yet available.The following investigation is ongoing: product history review.The results will be included in the final report.Per gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: infection (e.G., aneurysm, device or access sites).
Event or Problem Description
On (b)(6) 2014, a patient presented with an abdominal aortic aneurysm (measured 56.5 mm) was treated with a gore® excluder® aaa endoprosthesis.On (b)(6) 2022, it was reported that the patient suffered spondylodiscitis with intervertebral abscess.On (b)(6) 2022, the patient underwent conversion to open repair.On (b)(6) 2022, it was reported that the patient had expired.
Event or Problem Description
On (b)(6) 2014, a patient presented with an abdominal aortic aneurysm (measured 56.5 mm) was treated with a gore® excluder® aaa endoprosthesis.On (b)(6) 2022, it was reported that the patient suffered spondylodiscitis with intervertebral abscess.On (b)(6) 2022, the patient underwent conversion to open repair.On (b)(6) 2022, it was reported that the patient had expired.Additional information stated that the patient expired due to persisting systemic infection originating from spondylodiscitis and endograft infection.
Additional Manufacturer Narrative
Updated d10 concomitant medical products: gore® excluder® aaa endoprosthesis - stent graft contralateral leg endoprosthesis (pxc121200).A review of the manufacturing and sterilization records indicated the lot met all pre-release manufacturing specifications.Engineering evaluation could not be conducted as the device was not returned.The reported complications may be the result of the patient¿s disease progression or disease symptoms, co-morbidities and conditions and surgical technique.Corrected a1: patient identifier.Corrected h6: updated health effect - clinical code to 1735 - bacterial infection.Code 1690 was inadvertently entered, but correct code should be 1735.Removed health effect - impact code to 1802 - death as it was inadvertently entered.Death is not related to the reported conversion but rather systemic infection.Add type of investigation code 4114 - device not returned.Updated investigation findings code to 213 - no device problem found.Code 3233 is no longer applicable.Updated investigation conclusions code to 4315 and 22, code 11 is no longer applicable.

• 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 WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14101531
• Report Number: 2017233-2022-02861
• Device Sequence Number: 20027891
• Product Code: MIH
• UDI-Device Identifier: 00733132610525
• UDI-Public: 00733132610525
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: 02/28/2017
• Device Model Number: RMT231216
• Device Catalogue Number: RMT231216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• 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: Hospitalization; Death; Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Race: White