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	02/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A talent aaa stent graft was implanted in the patient for endovascular treatment of a 10 cm max diameter abdominal aortic aneurysm.It was reported that a post-operative ct scan revealed bifurcate stent graft had migrated downward, resulting in a proximal type i endoleak.The patient received treatment.The physician implanted an endurant aortic cuff and aptus endoanchors to obtain seal.Imaging done at the end of the procedure still showed a minor proximal type i endoleak.The physician elected not to perform any additional treatment.Per the physician, the cause of stent graft migration leading to proximal type i endoleak was most likely due to patient's anatomy, infrarenal aortic neck dilatation.Per the physician, the cause of the residual type i endoleak, after the aortic cuff was implanted, was due to the patient anatomy of a short infrarenal aortic neck and the amount of heparin that was used during the procedure.The physician believed the residual proximal type i endoleak would self-resolve.No additional clinical sequelae were reported and the patient is being 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: 6411728
• Report Number: 2953200-2017-00403
• Device Sequence Number: 19063689
• Product Code: MIH
• UDI-Device Identifier: 00613994991515
• UDI-Public: 00613994991515
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/21/2017

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: 12/01/2018
• Device Model Number: ETTF3636C70E
• Device Catalogue Number: ETTF3636C70E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 03/16/2017
• 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