MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ENBF2816C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that a ct carried out 8 years later showed the graft was not apposed on the posterior aspect at the level of the top of the graft and angulated angiography showed a type ia endoleak.The bifurcated stent graft was fully expanded and sealed on the anterior surface, but not the posterior surface.The aorta was measuring 30mm at the level of the posterior graft marker.A 32mm cuff (etcf3232c49e) was implanted up to the level of the right renal artery gaining approximately 6mm of graft above the bifurcated stent graft on the posterior aspect.Eight endoanchors were then implanted, mainly on the posterior lateral side.After ballooning, the angiography showed a persistent type ia endoleak with much diminished rate of flow.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported, and the patient is being monitored.

• Brand Name: ENDURANT BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8539166
• Report Number: 2953200-2019-00536
• Device Sequence Number: 1730964
• Product Code: MIH
• UDI-Device Identifier: 00613994762498
• UDI-Public: 00613994762498
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2013
• Device Model Number: ENBF2816C145E
• Device Catalogue Number: ENBF2816C145E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/23/2019
• 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: Required Intervention
• Patient Age: 67 YR