MAUDE Adverse Event Report: MEDTRONIC ENDURANT ENDOGRAFT

Model Number ENBF3616C166E

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Test Result (2695)

Event Date 06/30/2015

Event Type  Injury  

Event Description

Pt had endurant endograft placed (b)(6) 2011 for abdominal aneurysm.Presented to ed w/severe rt lower quadrant abdominal pain.Ct scan revealed that the endograft had migrated caudally, requiring emergent operative repair.

• Brand Name: ENDURANT ENDOGRAFT
• Type of Device: ENDURANT ENDOGRAFT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4905739
• MDR Text Key: 17580959
• Report Number: MW5043910
• Device Sequence Number: 1
• Product Code: MIH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/06/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2013
• Device Model Number: ENBF3616C166E
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Weight: 100