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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The medical device remains implanted.Return not possible.(b)(4).Tubular support placed inside a blood vessel, canal, or duct to aid healing or relieve an obstruction.The investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.The investigation involved communication/interviews (either interpersonal or through technical means, e.G.Phone, e-mail) with persons close to the adverse event, e.G.Healthcare professionals (doctors, nurses etc.), the affected patient(s) or other users including, where appropriate, relatives or others engaged in caring for the affected patient.The actual device involved in the adverse event was not returned for testing despite requests by manufacturer.Medical device remains implanted.Investigation is ongoing, and results are not yet available.A conclusion has yet to be established as the investigation is incomplete.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2013, this patient underwent an endovascular treatment for an abdominal aortic aneurysm and right common iliac arterial aneurysm using gore® excluder® aaa endoprostheses.The patient tolerated the procedure.During the follow-up period, new aneurysms were formed in the left common iliac and internal iliac arteries.Therefore, an additional procedure was indicated for a possible type ib endoleak.On (b)(6) 2022, gore® excluder® iliac branch endoprostheses (ibe) were additionally implanted into the left iliac artery.The iliac branch component was deployed without problems.Two internal iliac components were placed in the internal iliac artery; however, type ib endoleak was found and the internal iliac artery was embolized eventually.During the additional procedure, it was found that the proximal end of the trunk-ipsilateral leg which implanted in the initial procedure was a little bit migrated distally though no type ia endoleak was noted.Therefore, an aortic extender was also additionally implanted into the aortic neck to prevent potential type ia endoleak.The final angiography showed no endoleak.The patient tolerated the procedure.
Additional Manufacturer Narrative
Codes were updated to reflect the investigational findings.

• 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 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14403805
• Report Number: 3007284313-2022-01913
• Device Sequence Number: 12164195
• 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: 2013
• 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): 10/26/2022

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: 12/31/2015
• 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: 04/15/2022
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 05/15/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2013
• 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: 83 YR
• Patient Sex: Male