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

Model Number	ETTF2828C70E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/16/2020
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 aneurx stent graft system (bifurcate and 4 limbs) were implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.An endurant cuff was implanted approximately 7 years post the index procedure in the then 120mm aaa for the treatment of a type ia endoleak.It was reported approximately 10 years post the index procedure, follow up ct demonstrated a type iiia endoleak where the endurant cuff and aneurx main body separated.Intervention was completed where a valiant navion stent graft was implanted and the endoleak confirmed as resolved.Per the physician the cause of the type iiia endoleak was due to tortuous anatomy and angled neck.No additional sequelae were reported and the patient is fine.

• Brand Name: ENDURANT II EXTENSION CUFF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 10641122
• Report Number: 9612164-2020-03799
• Device Sequence Number: 11674789
• Product Code: MIH
• UDI-Device Identifier: 00613994991492
• UDI-Public: 00613994991492
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

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: 05/08/2019
• Device Model Number: ETTF2828C70E
• Device Catalogue Number: ETTF2828C70E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/07/2020
• 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: Required Intervention
• Patient Age: 88 YR