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

Model Number	PXA230300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pxa260300/ 05109118 udi (b)(4).
Event or Problem Description
On (b)(6) 2007, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The patient tolerated the procedure.It was reported that angiogram images, dated (b)(6) 2021, revealed a possible proximal type i endoleak.It is unknown if there was aneurysm sac enlargement.On (b)(6) 2021 there was a reintervention.The physician implanted a gore® excluder® aaa endoprosthesis aortic extender in the proximal seal zone from the original procedure.The endoleak was resolved.The patient tolerated the reintervention procedure.
Additional Manufacturer Narrative
Addition h6: code 213.Addition h6: code 22-the gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to endoleak.
Additional Manufacturer Narrative
H6: added component code 515.

• 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
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12411554
• Report Number: 2953161-2021-01089
• Device Sequence Number: 20156685
• Product Code: MIH
• UDI-Device Identifier: 00733132609871
• UDI-Public: 00733132609871
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2021

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: 08/31/2009
• Device Model Number: PXA230300
• Device Catalogue Number: PXA230300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 08/03/2021; 12/17/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 11/10/2021; 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 100 KG