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

Model Number	PXA280300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Images were provided to gore and an imaging evaluation showed the following: the length from the proximal end of the device to the proximal end of the lesion appears to be ~11 mm.There appears to be some contrast at the proximal end of the device.The contrast is more visible on the delayed ct.There appears to be a pair of lumbars that are patent.The lumbars appear to communicate with the aneurysmal sac.Possible type ii endoleak.According to the gore excluder® aaa endoprostheses instructions for use, adverse events that may occur and/or require intervention include, but are not limited to: endoleak.
Event or Problem Description
On (b)(6) 2011, this patient was implanted with gore®excluder®aaa endoprostheses to treat an abdominal aortic aneurysm.On (b)(6) 2011, computed tomography (ct) scan revealed a proximal type i endoleak.On (b)(6) 2011, the patient underwent reintervention and an aortic extender component was implanted to treat the endoleak.The patient tolerated the procedure and the endoleak was resolved.On (b)(6) 2021, computed tomography (ct) scan for a suspected proximal type i endoleak.On (b)(6) 2021, the patient underwent reintervention and an aortic extender component was implanted to treat the endoleak.Angiography at this time determined the aneurysm had enlarged to 87mm however, the proximal type i was unable to be confirmed.The patient tolerated the procedure.
Additional Manufacturer Narrative
B7: patient medical history includes but is not limited to: chf, a fib, cad, hld, and of course aaa.D11: patient medications include but are not limited to: goxin, metoprolol, warfarin, furosemide, methimazole, allopurinol a4: corrected information.

• Brand Name: GORE EXCLUDERAAA 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: 12170765
• Report Number: 2953161-2021-01072
• Device Sequence Number: 11168338
• Product Code: MIH
• UDI-Device Identifier: 00733132609895
• UDI-Public: 00733132609895
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 10/31/2013
• Device Model Number: PXA280300
• Device Catalogue Number: PXA280300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 88