MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	PXT281218
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pxa280300/03640548, udi (b)(4).According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events which may occur and require intervention include endoleak.
Event or Problem Description
On (b)(6) 2006, the patient was implanted with five gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that computed tomography (ct) images revealed, (date of images is unknown) the patient had a type iii endoleak, the trunk-ipsilateral leg endoprosthesis migrated distal and separated from the aortic extender endoprosthesis.The reason for the endoleak is a component disconnect between the pxt281218/04175114 and pxa280300/03640548 devices.The physician reintervened and explanted the gore® excluder® aaa endoprostheses and performed a surgical conversion.The patient tolerated the procedure.It is unknown if all implanted devices (implanted but not involved in type iii endoleak pxc141400/03760286, pxc141000/04002548, and pxc141400/04246109) were explanted.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8700835
• Report Number: 2953161-2019-00044
• Device Sequence Number: 11320861
• Product Code: MIH
• UDI-Device Identifier: 00733132610280
• UDI-Public: 00733132610280
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2019

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: 12/31/2008
• Device Catalogue Number: PXT281218
• Device Lot Number: 04175114
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR