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	11/10/2017
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 iis stent graft system was implanted in a patient for the endovascular treatment of a 50 mm diameter abdominal aortic aneurysm.Final angiogram showed a successful evar.However, it was reported that, when the physician attempted to remove the guidewire from the main body side (left) some resistance was encountered.When fluoroscopic imaging was re-established, the bifurcated stent graft was no longer in its original position but was sitting in the aaa sac.It was reported that a secondary intervention was performed three days later to treat malposition of the endurant stent graft.During the re-intervention an endurant aui and endurant limb extension were implanted and a left to right fem-fem bypass performed.It was reported that post the implant of the aui a type ia endoleak was observed.Ten (10) aptus endoanchors were implanted.It was reported that the type ia endoleak was resolved with no follow up necessary.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information received on this case reported that as per the physician, the reason for the type 1a leak after the implantation of the aui device was caused by a collapsed suprarenal fixation constraining a portion of the aui device.As per the investigator, ballooning and implantation of endoanchors resolved the leak.No additional clinical sequelae were reported and the patient is fine.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: 7094681
• Report Number: 2953200-2017-01933
• Device Sequence Number: 903623
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2018

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: 07/13/2019
• Device Model Number: ETUF3214C102E
• Device Catalogue Number: ETUF3214C102E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/05/2018
• 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