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

Model Number	PXC201200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2012, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses (pxt261412 and pxc201200).Two endurant legs were additionally implanted to the ipsilateral side.The patient tolerated the procedure.On (b)(6) 2020, the patient underwent an additional procedure to treat a type ib endoleak of the ipsilateral endurant legs.A gore® excluder® aaa endoprosthesis (plc271200j) was added in the ipsilateral side.On (b)(6) 2022, the patient underwent an additional procedure as the left (ipsilateral) type ib endoleak was confirmed to remain.Two contralateral legs (plc141400j and plc141200j) were implanted into the left side and the treatment area was extended to the external iliac artery.Also, the left internal iliac artery was coil-embolized.The patient tolerated the procedure.A minor type ib endoleak of the contralateral excluder leg was also found, and an additional procedure was planned for it.The reporting physician commented as follows: during the initial procedure, the ipsilateral leg seemed to be undersized but preserving internal iliac artery was prioritized.The additional procedure in 2020 was performed in the same strategy.Therefore, type ib endoleak was not surprised.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
The medical device remains implanted.Return not possible.(b)(4).
Event or Problem Description
The following information was reported to gore: on (b)(6) 2012, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses (pxt261412 and pxc201200).Two endurant legs were additionally implanted to the ipsilateral side.The patient tolerated the procedure.On (b)(6) 2020, the patient underwent an additional procedure to treat a type ib endoleak of the ipsilateral endurant legs.A gore® excluder® aaa endoprosthesis (plc271200j) was added in the ipsilateral side.On (b)(6) 2022, the patient underwent an additional procedure as the left (ipsilateral) type ib endoleak was confirmed to remain.Two contralateral legs (plc141400j and plc141200j) were implanted into the left side and the treatment area was extended to the external iliac artery.Also, the left internal iliac artery was coil-embolized.The patient tolerated the procedure.A minor type ib endoleak of the contralateral excluder leg was also found, and an additional procedure was planned for it.The reporting physician commented as follows: during the initial procedure, the ipsilateral leg seemed to be undersized but preserving internal iliac artery was prioritized.The additional procedure in 2020 was performed in the same strategy.Therefore, type ib endoleak was not surprised.
Additional Manufacturer Narrative
Added g3/g4, h1/h2.Added h6: investigation findings and conclusions.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13583570
• Report Number: 2017233-2022-02756
• Device Sequence Number: 12173377
• Product Code: MIH
• UDI-Device Identifier: 00733132610044
• UDI-Public: 00733132610044
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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: 02/28/2015
• Device Model Number: PXC201200
• Device Catalogue Number: PXC201200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2012
• 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: 71 YR
• Patient Sex: Male