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

Model Number	PLC201400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Patient medications: aspirin 81mg; atorvastatin 40mg; biktarvy; fluoxetine 20mg; hydrochlorothiazide 12.5mg; lisinopril 10mg; tiotropium 18 mcg; vit d3 5000 units.
Event or Problem Description
On (b)(6) 2020, the patient reported emergently with a ruptured abdominal aortic aneurysm.The physician implanted a gore® excluder® aaa endoprosthesis featuring c3® delivery system and three gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2020, the patient was treated for a type ii endoleak.A gore® excluder® aaa endoprosthesis was used to resolve the endoleak.The reintervention was done due to the risk of serious injury caused by the previous rupture.The patient tolerated the procedure.

• 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: 10483714
• Report Number: 3013164176-2020-01032
• Device Sequence Number: 16847986
• Product Code: MIH
• UDI-Device Identifier: 00733132618552
• UDI-Public: 00733132618552
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: 01/01/2023
• Device Model Number: PLC201400
• Device Catalogue Number: PLC201400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/02/2020
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 84