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

Model Number	ETLW1620C146E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2021
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 the patient for the endovascular treatment of a 83 mm abdominal aortic aneurysm.It was reported that during the index procedure, the patient had a large aneurysm with minimal neck below renals artery.The physician then decided to perform bilateral chimneys for this procedure.Final angiogram was performed, where it was noted what appeared to be a gutter leak.An angiogram was performed about 6 weeks later and it was determined the patient had a type 1b endoleak from the right limb etlw1620c146e (b)(4).Intervention was performed for the ib endoleak where another endurant limb etlw1620c156e was implanted down to the right hypogastric artery.This resolved the ib endoleak.As per the physician there appeared to be no gutter endoleak present.As per the physician, the cause of the gutter endoleak event was anatomy related due to a short aortic neck below the renals artery.The physician stated the reason for the ib endoleak was due to not having enough graft in the right iliac artery no additional clinical sequalae were provided and the patient is fine.

• 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 ; EI
• MDR Report Key: 11632824
• Report Number: 9612164-2021-01355
• Device Sequence Number: 3547213
• Product Code: MIH
• UDI-Device Identifier: 00763000388997
• UDI-Public: 00763000388997
• 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: 2021
• 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): 04/08/2021

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: 11/18/2022
• Device Model Number: ETLW1620C146E
• Device Catalogue Number: ETLW1620C146E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/08/2021
• 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: 85 YR