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

Model Number	ENBF2820C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	03/05/2020
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 bifurcate stent graft system was implant for the endovascular treatment of a unknown size abdominal aortic aneurysm.It was reported that 8 years and 8 days post the index procedure, a ct was performed which showed a type ia endoleak and type iib endoleak.The patient was also complaining of abdominal pain.It was reported that the physician decided it was best to explant the graft.The graft was explanted on the same date.As per the physician the cause of the event can not be determined.No additional clinical sequalae were provided 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 ; IE
• MDR Report Key: 9824187
• Report Number: 9612164-2020-01148
• Device Sequence Number: 11530231
• Product Code: MIH
• UDI-Device Identifier: 00613994762450
• UDI-Public: 00613994762450
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

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: 05/17/2013
• Device Model Number: ENBF2820C166E
• Device Catalogue Number: ENBF2820C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/12/2020
• 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: Other; Required Intervention
• Patient Age: 72 YR