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

Model Number	ENBF2313C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/08/2018
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 ii stent graft system was implanted in a patient for the endovascular treatment of a 50mm diameter abdominal aortic aneurysm.It was reported that, approximately 4 years post index procedure the patient presented with abdominal tenderness.On ct exam there appeared to be a type ia endoleak.The next day, after endoanchors deployment for the type ia endoleak, the angiogram revealed a jetting endoleak from the wall of the main body of the bifurcated device.An aortic cuff was deployed and sealed the hole but on the next angiogram another hole was observed in the contralateral limb.The physician relined the limb with a 16x16x82 endurant limb and the final angiogram showed the endoleak had resolved.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae 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: 7395049
• Report Number: 2953200-2018-00473
• Device Sequence Number: 11070905
• Product Code: MIH
• UDI-Device Identifier: 00613994762313
• UDI-Public: 00613994762313
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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: 02/21/2014
• Device Model Number: ENBF2313C166E
• Device Catalogue Number: ENBF2313C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/04/2018
• 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