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

Model Number	RLT261418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the devices verified the lots met all pre-release specifications.Also was used plc201200/13600420 udi # (b)(4).The devices were explanted/discarded and were not available for analysis.According to the 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) and surgical conversion.Please note that the event date will be used as (b)(6) 2019 when the scan confirmed the infection.
Event or Problem Description
On (b)(6) 2016, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 55mm in diameter and was implanted with gore® excluder® endoprostheses.The patient tolerated the procedure.Reportedly, the maximum diameter of aortic aneurysm/lesion decreased in size from 55 to 42mm.It was reported that the patient developed fatigue in (b)(6) 2019 and had a ct that showed low attenuation fluid collection in left psoas.An indium-111 wbc scan completed on (b)(6) 2019 confirmed the infection of the aortic devices and the aneurysm.According to the physician, bacteroides fragilis was the cause of infection from previously performed fluid aspiration.The infection could not be directly attributed to the gore devices, as the patient had a long and complex medical history that could have also attributed to the infection.The patient suffered from iron deficiency anemia which could have possibly attributed to infection.Also, the infection could not be directly attributed to the procedure performed on (b)(6) 2016.Reportedly, there was no prior history of infection.On (b)(6) 2019, the patient underwent the explant procedure and onix coils and had a replacement graft placed.The patient was discharged on (b)(6) 2019.The patient passed away on (b)(6) 2020.A note in our emr mentions it was due to cardiac arrest.The explanted devices are not available for investigation.

• 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
• MDR Report Key: 10855700
• Report Number: 3007284313-2020-01156
• Device Sequence Number: 19635954
• Product Code: MIH
• UDI-Device Identifier: 00733132622474
• UDI-Public: 00733132622474
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2020

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: 10/31/2017
• Device Model Number: RLT261418
• Device Catalogue Number: RLT261418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 93