MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	RLT281216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concominant medical devices: pt medications: aspirin, atorvastatin, clopidogrel, and losartan.(b)(4).
Event or Problem Description
On (b)(6) 2018, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that the patient had a proximal type i endoleak.There is no aneurysm sac enlargement reported.The cause for the type i endoleak is unknown.On (b)(6) 2020, the physician reintervened and snorkeled the renal arties bilaterally and implanted three gore® excluder® aaa aortic extender endoprostheses proximally to the superior mesenteric artery.The endoleak was diminished but not completely resolved at the end of the case.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition h6 code 2.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9665274
• Report Number: 3007284313-2020-00028
• Device Sequence Number: 14181282
• Product Code: MIH
• UDI-Device Identifier: 00733132622504
• UDI-Public: 00733132622504
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: 01/14/2021
• Device Model Number: RLT281216
• Device Catalogue Number: RLT281216
• Device Lot Number: 17653117
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/17/2020
• 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; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 74