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

Model Number	RLT311415
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Ruptured Aneurysm (4436)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, this patient underwent an endovascular procedure and was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.Several follow-up computed tomography (ct) scans were performed over the next two years with the physician reportedly noting a small possible type ii endoleak causing minor sac expansion during this time.The physician continued to monitor the patient.On (b)(6) 2021, the patient presented with a slow rupture and a type 1a endoleak.However, it was reported that the physician suspected the type ii endoleak having led to the sac expansion and the rupture.Also on (b)(6) 2021, all endoprostheses were explanted.Reportedly, the patient is currently recovering.
Additional Manufacturer Narrative
H6: component code: added code 515.H6: investigation findings: code 213 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.H6: investigation conclusions: added codes 4315, 22.Code 22: 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: endoleak, aneurysm enlargement, aneurysm rupture, surgical conversion.The explanted endoprotheses as well as images were requested but reportedly not available.H6: health effect - clinical code: code 1708 was retracted.

• 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: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12492140
• Report Number: 3007284313-2021-01589
• Device Sequence Number: 19899436
• Product Code: MIH
• UDI-Device Identifier: 00733132619085
• UDI-Public: 00733132619085
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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: 11/07/2021
• Device Model Number: RLT311415
• Device Catalogue Number: RLT311415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2018
• 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: Required Intervention
• Patient Sex: Male