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	03/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An aneurx stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that a ct demonstrated that the aneurx stent graft had migrated distally with a proximal type i endoleak.The patient presented with abdominal pain.The aneurysm is currently 7.6 cm in diameter.The ct revealed that the aneurx stent graft has migrated distally 3 cm, the aortic neck is currently 29 mm in diameter at the renal arteries and 33 mm in diameter 25 mm distal to the renal arteries.The physician elected to implant an endurant 36x36x70 aortic cuff and aptus endoanchors and the migration was resolved, however there was still a slight type i endoleak present.The physician stated that the cause of the event is related to the patient's anatomy and there was disease progression with aortic neck dilatation.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that, per the physician, the cause for the residual type ia endoleak after the secondary intervention was due to a short reverse funnel neck.
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: 6455349
• Report Number: 2953200-2017-00509
• Device Sequence Number: 11107131
• Product Code: MIH
• UDI-Device Identifier: 00613994991515
• UDI-Public: 00613994991515
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2017

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: 11/02/2018
• Device Model Number: ETTF3636C70E
• Device Catalogue Number: ETTF3636C70E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: Not provided; 05/10/2017
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 06/01/2017; 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: 70 YR