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

Model Number	RLT281418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/17/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient medical history includes but is not limited to: coronary artery disease, hypercholesterolemia, hypertension, tobacco use, peripheral vascular disease.As gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: plc201400/ (b)(4), pxl161207/(b)(4).As gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: antimicrobial therapy: vancomycin, piperacillin-tazobactam, doxycycline.(b)(4) 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: endoprosthesis: infection, pseudoaneurysm, death.Other patient medications include but are not limited to: albuteral, atorvastatin, docusate, hydrochlorothiazide, levothyroxine, linisopril, triamcinolone.
Event or Problem Description
On (b)(6) 2015, this patient underwent endovascular treatment of an abdominal aortic aneurysm with a maximum diameter of 53.6 mm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure and was discharged from the hospital on (b)(6) 2015.On (b)(6) 2016, the patient underwent follow-up computed tomography angiography (cta) which determined the maximum diameter of the aneurysm measured 43 mm.On (b)(6) 2016, the patient underwent follow-up computed to cta which determined the maximum diameter of the aneurysm measured 40 mm.On (b)(6) 2017, follow-up ultrasound determined the maximum diameter of the aneurysm measured 34 mm.On (b)(6) 2017, the patient underwent follow-up computed tomography angiography (cta) which determined the maximum diameter of the aneurysm measured 36 mm.On (b)(6) 2018, follow-up ultrasound determined the maximum diameter of the aneurysm measured 38 mm.On (b)(6) 2019, follow-up ultrasound determined the maximum diameter of the aneurysm measured 41 mm.On (b)(6) 2020, follow-up ultrasound determined the maximum diameter of the aneurysm measured 41 mm.On (b)(6) 2021, the patient underwent medical management treatment for an infection of an infected stent graft, which is the onset date for the infection.On (b)(6) 2021, the patient underwent aortic reconstruction with cryotheraphy, all devices were reported to have been explanted.On (b)(6) 2021, the patient expired.A cause of death was not provided.
Additional Manufacturer Narrative
B5: additional details provided.H6: added component code.H6: code 213: a review of the manufacturing and sterilization records for the devices indicated the lots met all pre-release sterilization specifications.
Event or Problem Description
On (b)(6) 2021, the patient underwent aortic reconstruction using cryotheraphy, for infection of the aortic stent grafts and a pseduoaneurysm all devices were reported to have been 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13233107
• Report Number: 3007284313-2022-01745
• Device Sequence Number: 19983111
• Product Code: MIH
• UDI-Device Identifier: 00733132622559
• UDI-Public: 00733132622559
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: 06/09/2018
• Device Model Number: RLT281418
• Device Catalogue Number: RLT281418
• 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: 12/22/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2015
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Life Threatening; Death; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Race: White