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

Model Number	PLC231000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medical history incudes but is not limited to: thombocytopenia, gerd w/out esophagitis, popliteal aneurysm, perforated nasal septum, mixed hyperlipidemia, arterial aneurysm, hypertension, etd.Patient medications include but are not limited to: losartan, prilosec, plavix, tylenol, multivitamin.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: endoleaks.
Event or Problem Description
On (b)(6) 2017, this patient underwent treatment for an abdominal aortic aneurysm and a right common iliac artery aneurysm (rciaa) and was implanted with gore® excluder® aaa endoprostheses and gore® excluder® lliac branch endoprostheses.The patient tolerated the procedure.On (b)(6) 2021, the patient underwent reintervention to treat a distal type i endoleak associated with a 23 contralateral leg component used to extend coverage on the left side due to elongation of the internal iliac artery and a full occlusion of the left internal iliac artery.Two additional contralateral leg components were placed distally on the left side.The endoleak was resolved.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: 12081722
• Report Number: 2953161-2021-01068
• Device Sequence Number: 3503311
• Product Code: MIH
• UDI-Device Identifier: 00733132618576
• UDI-Public: 00733132618576
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

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: 12/01/2019
• Device Model Number: PLC231000
• Device Catalogue Number: PLC231000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 84