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

Catalog Number	PXT261416
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Atrial Perforation (2511)
Date of Event	07/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient¿s medications include; gleevec, coumadin, atorvastatin, aspirin, metoprolol, and finasteride.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to component migration, aneurysm enlargement and rupture.
Event or Problem Description
On (b)(6) 2006, the patient underwent endovascular treatment of an abdominal aortic aneurysm with four gore® excluder® aaa endoprostheses.On (b)(6) 2018, the patient presented to the hospital emergency department with a ruptured aortic aneurysm.Imaging revealed the proximal aortic neck had dilated over time due to disease progression.Reportedly, the trunk-ipsilateral leg component had loss circumferential wall apposition and had migrated distally (~5cm).It was reported, the aneurysm had enlarged (amount unknown), resulting in rupture.That same day, an emergent procedure was performed whereby two medtronic aortic extenders were implanted for proximal extension to the level of the renal arteries.On (b)(6) 2018, a post-implant ultrasound identified evidence of a type iii endoleak/disconnect between the gore trunk-ipsilateral leg component and the medtronic devices.An additional procedure was performed, whereby an aptus endoanchor system was used to fixate the previously implanted gore and medtronic devices to the proximal aortic wall.Final angiography showed resolution of the rupture, good patency of all devices and the patient was reported to have tolerated the procedure.

• 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: 7692579
• Report Number: 2953161-2018-00065
• Device Sequence Number: 2643272
• Product Code: MIH
• UDI-Device Identifier: 00733132610235
• UDI-Public: 00733132610235
• 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: 2006
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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: 06/30/2009
• Device Catalogue Number: PXT261416
• Device Lot Number: 04487374
• 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: 07/16/2018
• 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: 85 YR
• Patient Weight: 80