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

Catalog Number	PXT261218
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2005, this patient underwent endovascular treatment of an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2019, follow-up computed tomography illustrates approximately 18mm distal migration of the device.On an unknown date, the patient underwent reintervention and a medtronic cuff was placed proximally.On (b)(6) 2019, computed tomography images show a type iii endoleak and a slight separation of the excluder device and the medtronic device.On (b)(6) 2019, the patient underwent reintervention and a gore® aortic extender component was placed proximally to regain proximal seal and treat the endoleak.Additionally, two contralateral leg components were placed on either side to ensure coverage of the disconnect area of the type iii endoleak.It was reported that degeneration of the patient's proximal aortic neck was also a factor.The patient tolerated the procedure and the endoleak was resolved.
Additional Manufacturer Narrative
B6: corrected/additional information.

• 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: 9587858
• Report Number: 3013164176-2020-00005
• Device Sequence Number: 19667481
• Product Code: MIH
• UDI-Device Identifier: 00733132610204
• UDI-Public: 00733132610204
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2019

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: 07/31/2008
• Device Catalogue Number: PXT261218
• Device Lot Number: 03868498
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 01/15/2020
• 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; Other; Required Intervention
• Patient Age: 86 YR