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

Model Number	PXC201000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).It should be noted the gore® excluder® aaa endoprosthesis instructions for use (ifu) state ¿adverse events that may occur and / or require intervention include, but are not limited to, endoleak.¿.
Event or Problem Description
On (b)(6) 2011, a patient underwent endovascular treatment of an abdominal aortic aneurysm using a non-gore manufactured stent graft as a main body, and a gore® excluder® contralateral leg component implanted distally on each side.On unknown date, a follow-up examination reportedly revealed bilateral distal type i endoleaks.Additional event information, including the cause of the endoleaks, was requested but not available.On (b)(6) 2022, a reintervention was performed to treat both type i endoleaks.The right internal iliac artery was coil embolized, and an additional gore® excluder® component was implanted to extend the stent graft system distally on the right side.An intra-operative angiograph at the left leg revealed no distal type i endoleak, but the physician reportedly elected to implant an additional gore® excluder® iliac branch endoprosthesis on the left side.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code 213: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: conclusion coding updated.It should be noted the gore® excluder® aaa endoprosthesis instructions for use (ifu) state ¿adverse events that may occur and / or require intervention include, but are not limited to, endoleak.¿.

• 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 WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14340246
• Report Number: 2017233-2022-02911
• Device Sequence Number: 6256223
• Product Code: MIH
• UDI-Device Identifier: 00733132610037
• UDI-Public: 00733132610037
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 06/01/2022

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: 10/31/2013
• Device Model Number: PXC201000
• Device Catalogue Number: PXC201000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female