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

Model Number	ETCF3636C49E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/22/2020
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
A talent bifurcate stent graft was implanted in a patient for the endovascular treatment of an 85 mm pre-rupture abdominal aortic aneurysm it was reported approximately 137 months post index procedure, the patient presented emergently, with complaints of abdominal pain.Ct was performed and showed what appeared to be a type 1a endoleak.It was reported that the physician decided to treat the endoleak by placing a etcf3636c49e cuff and a heli-fx endoanchor system.It was stated that the type 1 endoleak was still noted after the devices were implanted.The physician then decided to place a bilateral chimneys using a non-medtronic stents in the right and left renal artery.Ettf3636c70e was also implanted to treat the event.Final angiography was performed with no endoleak found.As per the physician, cause of the event cannot be determined.No additional clinical 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: 10424296
• Report Number: 9612164-2020-03027
• Device Sequence Number: 2987065
• Product Code: MIH
• UDI-Device Identifier: 00613994991461
• UDI-Public: 00613994991461
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/19/2020

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: 01/14/2021
• Device Model Number: ETCF3636C49E
• Device Catalogue Number: ETCF3636C49E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/19/2020
• 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