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

Model Number	ETUF2514C102E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/24/2017
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 endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 5.3 cm in diameter abdominal aortic aneurysm.The aortic was short in length and calcified.It was reported that during the initial procedure the endurant aui stent graft had a proximal type i endoleak.The physician elected to implant four aptus endoanchors; however, the proximal type i endoleak was not completely resolved.The physician stated that the event is related to the patient¿s anatomy of a short and calcified proximal aortic neck.The physician will continue to monitor the patient.No additional clinical sequelae were reported and the patient is fine.
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 AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6294308
• Report Number: 2953200-2017-00137
• Device Sequence Number: 19083010
• Product Code: MIH
• UDI-Device Identifier: 00643169232570
• UDI-Public: 00643169232570
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/24/2017

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: 12/12/2018
• Device Model Number: ETUF2514C102E
• Device Catalogue Number: ETUF2514C102E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: 84 YR