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

Model Number	RMT261414
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #plc181200/ serial #(b)(4) / udi #(b)(4).Catalog #pla280300/ serial #(b)(4) / udi #(b)(4).Patient weight: asked but unavailable.Concomitant medical products and therapy dates: aspirin 81mg, lisinopril 40mg, oxycodone-acetaminophen 5-325mg, fish oil capsule, bactrim ds 800-160mg.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, endoleak, aneurysm enlargement, and surgical conversion.
Event or Problem Description
On (b)(6) 2014 the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.The initial aneurysm size is reportedly unavailable.On (b)(6) 2017 a reintervention was performed whereby an aortic extender component was placed to treat a proximal type i endoleak.No additional information regarding the endoleak or intervention was available.On (b)(6) 2020 the patient underwent reintervention due to a reported growing abdominal aortic aneurysm.The cause of the aneurysm growth was reportedly unknown.Reportedly the aneurysm measured 10cm.The device system was explanted.The explanted devices were discarded.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: 10667439
• Report Number: 3007284313-2020-01108
• Device Sequence Number: 3960365
• Product Code: MIH
• UDI-Device Identifier: 00733132610631
• UDI-Public: 00733132610631
• 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: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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: 10/31/2014
• Device Model Number: RMT261414
• Device Catalogue Number: RMT261414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/12/2020
• 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: 84 YR