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

Model Number	PXC121000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On an unspecified date in 2002 the patient was implanted with a non-gore aortic trunk device (ancure) for treatment of an abdominal aortic aneurysm.On (b)(6) 2011 the patient was implanted with a gore® excluder® aaa endoprosthesis iliac extender (pxl161407).On (b)(6) 2013 a reintervention occurred in which the existing configuration, including the gore® excluder® aaa endoprosthesis iliac extender, was relined with the following gore devices: 3 gore® excluder aortic extender endoprosthesis (pxa230300), 1 gore® excluder contralateral leg endoprosthesis (pxc121000), and 1 gore® iliac extender endoprosthesis (pxl161207).The specific reason for the reintervention is unknown.On (b)(6) 2021 the patient underwent endovascular treatment for a type ib endoleak.It is unknown when the endoleak was first identified.The cause of the endoleak is unknown.As reported there was observed dilation on the left common iliac.Coil embolization of the left internal iliac was performed and a gore® excluder® aaa endoprosthesis contralateral leg component (plc121400) was landed in the left external iliac in order to address the endoleak and extend coverage.A lack of circumferential seal was noted in the right common iliac so coverage was also extended on the right with a gore® excluder® aaa endoprosthesis iliac extender (plc161000).
Additional Manufacturer Narrative
H6: code 213: no device problem found.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Code 4315: cause not established.Code 22: known inherent risk of device.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require additional intraoperative procedure time or intervention include, but are not limited to endoleak and aneurysm enlargement.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13048830
• Report Number: 2953161-2021-01109
• Device Sequence Number: 13849130
• Product Code: MIH
• UDI-Device Identifier: 00733132609918
• UDI-Public: 00733132609918
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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: 08/31/2015
• Device Model Number: PXC121000
• Device Catalogue Number: PXC121000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 86 KG