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

Model Number	ENCF3232C49E
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Death (1802); Rupture (2208)
Date of Event	02/22/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An aneurx stent graft system was implanted in the patient for the endovascular treatment of a ruptured unknown diameter abdominal aortic aneurysm and subsequent implantation of another aneurx stent graft and endurant stent graft was also performed.It was reported that the patient presented emergently with a ruptured abdominal aortic aneurysm.The patient was receiving treatment with the attempted implantation of an aui device but then expired during this procedure.As per the physician, the cause of the event was due to migration of the stent graft.No additional clinical sequelae were reported.

• Brand Name: ENDURANT EXTENSION CUFF STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7353686
• Report Number: 2953200-2018-00398
• Device Sequence Number: 2024030
• Product Code: MIH
• UDI-Device Identifier: 00613994762085
• UDI-Public: 00613994762085
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/20/2018

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: 11/14/2012
• Device Model Number: ENCF3232C49E
• Device Catalogue Number: ENCF3232C49E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/20/2018
• 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: Death; Required Intervention
• Patient Age: 70 YR