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

Model Number	ENBF2516C166E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximate date.Year only valid.A good faith effort will be made to obtain the applicable information relevant to the report.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 an 8.0 cm abdominal aortic aneurysm.It was noted that there was 30 degrees of angulation.It was reported that the patient previously had another manufacturer¿s cuff and limb implanted for a type ia and ib, respectively.The type ib reportedly resolved but the type ia remained.The patient then presented emergently with a migration and type ia endoleak.18 heli-fx endoanchors were implanted along with a 32 endurant aortic cuff and another manufacturer¿s stent.A leak still remained but it could not be determined if it was a type ia or a type ii.The physician stated that the cause of the migration and type ia was due to disease progression; and the cause of the type ib was due to under-sizing.No additional clinical sequelae were reported and the patient is being monitored by their physician.

• 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: 6855458
• Report Number: 2953200-2017-01420
• Device Sequence Number: 13640766
• Product Code: MIH
• UDI-Device Identifier: 00613994762221
• UDI-Public: 00613994762221
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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: 01/25/2014
• Device Model Number: ENBF2516C166E
• Device Catalogue Number: ENBF2516C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 09/11/2017
• 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: 85 YR