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

Model Number	ETUF3214C102E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/09/2019
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
An endurant aui stent graft system was implanted in a patient for the endovascular treatment of a 90mm abdominal aortic aneurysm.It was reported during the index procedure after the aui stent and fem- fem by pass was completed a type ia endoleak was identified.The physician re-ballooned with a reliant balloon.The physician then elected to implant 10 heli-fx endoanchors and while the endoleak improved it was not fully resolved.The procedure was completed at this time.Per the physician the cause of the endoleak was anatomy related due to an angulated infrarenal neck.No additional clinical sequelae were reported, and the patient will be monitored.
Additional Manufacturer Narrative
Additional information received reported that 10 additional endoanchors were implanted approximately one month post index procedure to treat the type 1a endoleak, however the endoleak did not resolve.A chevar procedure was then carried out on both renal arteries and a endurant aortic cuff was used to extend proximally to the sma to treat the endoleak.It was reported that the endoleak was much improved but not completely resolved.The patient will continue to be monitored.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: 9191742
• Report Number: 9612164-2019-04365
• Device Sequence Number: 17076524
• Product Code: MIH
• UDI-Device Identifier: 00643169232617
• UDI-Public: 00643169232617
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 05/13/2021
• Device Model Number: ETUF3214C102E
• Device Catalogue Number: ETUF3214C102E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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: 71 YR