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

Model Number	ENBF2316C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/27/2018
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 the patient for the endovascular treatment of an unknown size abdominal aortic aneurysm.Approximately six years later, a type ia endoleak was observed during a follow up ct.It was reported the stent graft was 1cm from the level of the lowest renal but the physician reported there were no previous films so he was unable to tell if the graft had migrated.An intervention procedure was carried out approximately two weeks later to treat the endoleak.An endurant cuff was implanted up to the level of the lowest renals.Four endoanchors were also placed at the proximal end of the cuff to ensure good seal.The event is reported to be resolved with no sign of the type ia endoleak on the angiogram carried out at the end of the procedure.The physician reported the cause of the event to be progressive neck dilation.No additional clinical sequalae were reported and the patient is fine.

• 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: 7973851
• Report Number: 2953200-2018-01476
• Device Sequence Number: 16457480
• Product Code: MIH
• UDI-Device Identifier: 00613994762290
• UDI-Public: 00613994762290
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2013
• Device Model Number: ENBF2316C145E
• Device Catalogue Number: ENBF2316C145E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/17/2018
• 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: Required Intervention
• Patient Age: 70 YR