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

Model Number	ETLW1616C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: e tlw1616c93e, serial/lot #: (b)(4), ubd: 21-apr-2022, udi#: (b)(4); product id: etlw1616c124e, serial/lot #: (b)(4), ubd: 20-may-2022, udi#: (b)(4); product id: etlw1616c93e, serial/lot #: (b)(4), ubd: 06-apr-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An aneurx bifurcate stent graft system was implanted in the endovascular treatment of a >50mm abdominal aortic aneurysm.An aortic cuff aexch242440 was also implanted.It was reported that on the date of an angiogram 8 years later , it was noted that the patient had a type ia endoleak.It was reported the aortic cuff aexch242440 had migrated.Intervention took place 6 days later, an endurant cuff etcf2525c49e & endoanchors were implanted to resolve the ia endoleak & migration.It was noted during this intervention, a type iiib endoleak was observed in the aneurx bifurcate main body graft.  the physician realigned and implanted endurant limbs and extended them equally proximally to prevent the leak.  at the end of case there was still a type iii leak but there was significantly less leakage.As per the physician the cause of the ia endoleak was anatomy and noted the aortic neck widened.No cause of the iiib endoleak was reported.No additional clinical sequelae were provided and the patient will be monitored.

• 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 ; IE
• MDR Report Key: 10783696
• Report Number: 9612164-2020-04227
• Device Sequence Number: 4135094
• Product Code: MIH
• UDI-Device Identifier: 00643169467576
• UDI-Public: 00643169467576
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2021
• Device Model Number: ETLW1616C82E
• Device Catalogue Number: ETLW1616C82E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/04/2020
• 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: 83 YR