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

Model Number	ENLW1610C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	07/01/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant bifurcate stent graft system was implanted in the endovascular treatment of a unknown sized abdominal aortic aneurysm.It was reported that approximately 8 years and 5 months post implant the patient had a ib endoleak of the left limb.Intervention was performed and the physician placed coils behind the limb of the graft and the endoleak appeared to be resolved.Approximately 5 months later, the patient presented with a ruptured aneurysm.The patient was reported as very unstable.There appeared to be ia endoleak observed on angio and an endurant aortic cuff was implanted.An endurant limb was being prepped to be implanted next but as this was being done, the patient became pulseless.Cpr was performed but the patient did not respond and the patient expired.As per the physician the cause of the endoleaks are unknown.The cause of the rupture was reportedly due to the ib endoleak.No additional clinical sequalae were reported and the patient is expired.

• Brand Name: ENDURANT ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11035888
• Report Number: 9612164-2020-04984
• Device Sequence Number: 1086943
• Product Code: MIH
• UDI-Device Identifier: 00613994762009
• UDI-Public: 00613994762009
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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: 01/17/2014
• Device Model Number: ENLW1610C124E
• Device Catalogue Number: ENLW1610C124E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2020
• Initial Report FDA Received Date: 12/18/2020
• 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: Death; Required Intervention
• Patient Age: 85 YR