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	Injury (2348)
Date of Event	03/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An aneurx stent graft was implanted in a patient for the endovascular treatment an abdominal aortic aneurysm.It was reported that the aneurx stent graft has migrated distally with a proximal type i endoleak.The physician elected to implant an endurant aortic cuff.The migration and type i endoleak were resolved.It was reported that the patient presented emergently.The ct revealed that there was a proximal type i endoleak and a contained aneurysm rupture.The physician elected to implant an endurant aortic cuff, snorkel the renal arteries and implant aptus endoanchors.Three aptus endoanchors were successfully implanted in the patient however, when the physician attempted to load the 4th endoanchor in the heli-fx applier there was a double beep sound and the endoanchor would not load.The physician changed to another heli-fx applier and the same exact event occurred.The final angiogram revealed that the proximal type i endoleak was not resolved.The patient is being evaluated for open repair.Per the physician, the cause of the stent graft migration, proximal type i endoleak and aneurysm rupture were related to patient anatomy of disease progression and the cause of the heli-fx event cannot be determined.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 6446561
• Report Number: 2953200-2017-00484
• Device Sequence Number: 16404474
• Product Code: MIH
• UDI-Device Identifier: 00613994991515
• UDI-Public: 00613994991515
• 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,Followup
• Report Date (Section B): 03/08/2017

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: 12/01/2018
• Device Model Number: ETTF3636C70E
• Device Catalogue Number: ETTF3636C70E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: 83 YR