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

Model Number	ETCF3232C49E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An aneurx bifurcated stent graft system was implanted in the patient for the endovascular treatment of an unknown sized aaa.Under 13 years later, an angiogram showed a possible type ia endoleak.A ct was performed afterwards and showed the ia endoleak and that the graft had migrated distally.It was reported intervention was performed where an etuf3232c49e was implanted, it was reported the endoleak was still present so an additional etuf3232c49e was extended proximally 4mm more to the lowest renal artery.After ballooning there was still a small type 1a endoleak.The physician decided to stop the procedure.Per the physician, the cause of the event was patient anatomy due to an angled neck no additional clinical sequalae were reported and the patient will be monitored.

• Brand Name: ENDURANT II EXTENSION CUFF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12364443
• Report Number: 9612164-2021-03280
• Device Sequence Number: 17137298
• Product Code: MIH
• UDI-Device Identifier: 00613994991454
• UDI-Public: 00613994991454
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2023
• Device Model Number: ETCF3232C49E
• Device Catalogue Number: ETCF3232C49E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR