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

Model Number	ETLW1610C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/16/2019
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 stent graft system was implanted in a patient for the endovascular treatment of a 44 mm diameter abdominal aortic aneurysm.The infra-renal neck was small in diameter measuring 14 mm and long measuring 27 mm.Approximately four years later the physician reported that the neck has dilated to 55 mm.It was noted that a non mdt stent that was placed with the endurant bifurcate in the index procedure is not opposed to the stent graft and there is a new type ia endoleak.An intervention was carried out to treat the type ia endoleak with heli-fx endoanchors which were placed posterior and to the right where the endoleak was visualized.It was noted that the endoanchors were not successful in resolving the endoleak.It was also noted during the intervention procedure that a type ib endoleak ws observed at the right side and a non mdt stent graft was added to extend the limb by 15 mm, landing proximal to the riia.This endoleak was resolved.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the type ib endoleak appeared to be coming from the iliac dilating around the vessel.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8981083
• Report Number: 9612164-2019-03839
• Device Sequence Number: 19678276
• Product Code: MIH
• UDI-Device Identifier: 00643169467644
• UDI-Public: 00643169467644
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 01/27/2017
• Device Model Number: ETLW1610C124E
• Device Catalogue Number: ETLW1610C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/02/2019
• 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