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

Model Number	PXT281218
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: pxa280300/05209812 udi: (b)(4).Pxa230300/7347562 udi: (b)(4).According to the instructions for use (ifu) for the gore® excluder® aaa endoprosthesis; adverse events that may occur include, but are not limited to: endoleak a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2010, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.On (b)(6) 2020, the patient presented emergently and underwent treatment for a rupture of the aneurysm caused by a type iii endoleak.It was reported that the main body (trunk ipsilateral leg component) had migrated distally and there was a disconnect to the aortic extender components originally placed to extend coverage.A gore® tag® conformable thoracic stent graft with active control system was placed to successfully treat and resolve the type iii endoleak.The patient tolerated the procedure.Additionally, it was reported that the patient had been monitored for a type ii endoleak with unknown enlargement, but had not been seen within the past year and a half.

• 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: 10009793
• Report Number: 2953161-2020-00011
• Device Sequence Number: 2896784
• Product Code: MIH
• UDI-Device Identifier: 00733132610280
• UDI-Public: 00733132610280
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 07/31/2012
• Device Model Number: PXT281218
• Device Catalogue Number: PXT281218
• Device Lot Number: 7044360
• 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: 04/29/2020
• Supplement Report FDA Received Date: 04/29/2020
• 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: 81 YR
• Patient Weight: 107