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

Model Number	PXT261414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2012, this patient underwent endovascular treatment using gore® excluder® aaa endoprosthesis for abdominal aortic aneurysm.Non-gore bare metal stents (luminexx) were implanted to reline bilateral legs.The patient tolerated the procedure.On (b)(6) 2021, it was reported that bilateral common iliac became aneurysmal in the treated area.Endoleaks were noted bilaterally.The bilateral internal iliac arteries were embolized, and additional stent grafts were deployed to extend the device to bilateral external iliac artery.The patient tolerated the procedure.(this was reported on mfr report # 2017233-2021-02392) on (b)(6) 2021, a type iii disconnect endoleaks between the trunk-ipsilateral leg endoprosthesis and contralateral leg endoprostheses was discovered by postoperative computer tomography image.On (b)(6) 2021, the patient underwent reintervention.Bilateral limbs were relined with additional stent grafts.The type iii endoleaks were resolved.During the procedure, a slight type ii endoleak was observed, and the endoleak will be monitored.The patient tolerated the procedure.The physician stated as follows; the bms (luminex 14mm-60mm) on both sides that implanted in initial procedure had been deployed from a higher position than expected.The physician speculated that the endoleak occurred because the proximal portion of the contralateral leg endoprostheses implanted august 19 did not achieve sufficient overlap seal with the luminex devices.
Additional Manufacturer Narrative
H6: investigation findings and investigation conclusion codes.

• 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 PHOENIX 1; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12507697
• Report Number: 2017233-2021-02393
• Device Sequence Number: 5159317
• Product Code: MIH
• UDI-Device Identifier: 00733132610228
• UDI-Public: 00733132610228
• 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: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2022

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: 11/30/2014
• Device Model Number: PXT261414
• Device Catalogue Number: PXT261414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 08/23/2021; 03/11/2022
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 09/23/2021; 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2011
• 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: 81 YR
• Patient Sex: Male