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

Model Number	PXA230300
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Code "other" was selected as the medical device remains implanted.Return not possible.A severe injury, illness or impairment which requires hospitalization or medical intervention.Problem with all or part of an implanted or invasive device moving from its intended location within the body.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.The device either functioned as intended or a problem was not found.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2011, a patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.Pxa230300 was implanted distally in the left leg.On unknown date, at a follow-up, an enlargement of a left common iliac artery was observed, leading to a migration of the stent graft to distal.On (b)(6) 2021, reintervention was performed.Left internal iliac artery was embolized using coil.Plc141400j was implanted from the flow divider and pla121400j was implanted to extend to a left internal iliac artery.The patient tolerated the procedure.The physician stated that it had been ten years since the initial treatment, this event occurred as an inevitable.

• Brand Name: GORE EXCLUDERAAA 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
• MDR Report Key: 12568061
• Report Number: 2953161-2021-01096
• Device Sequence Number: 17167526
• Product Code: MIH
• UDI-Device Identifier: 00733132609871
• UDI-Public: 00733132609871
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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: 03/31/2014
• Device Model Number: PXA230300
• Device Catalogue Number: PXA230300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR