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

Model Number	ETTF3636C70E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
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 abdominal stent graft was implanted in an unknown endovascular procedure.It was reported that during a follow-up, approximately 159 months post index procedure, it was noted that the aneurx abdominal stent graft had migrated, which resulted in a type 1a endoleak and aneurysm expansion.The physician implanted an endurant ettf3636c70e to the level of the native left renal to attempt to treat the event, however the type i endoleak was not resolved.As per the physician, cause of the event was anatomy, due to aortic neck dilatation 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 TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 10656498
• Report Number: 9612164-2020-03870
• Device Sequence Number: 14245096
• Product Code: MIH
• UDI-Device Identifier: 00613994991515
• UDI-Public: 00613994991515
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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: 06/12/2021
• Device Model Number: ETTF3636C70E
• Device Catalogue Number: ETTF3636C70E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR