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

Model Number	ETLW1610C156E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted during an endovascular procedure for the treatment of a 36mm x 34mm right common iliac aneurysm sac. the right internal iliac artery was first plugged and coiled.It was reported the patient returned for a follow-up ct , a type ib endoleak was discovered on the endurant limb etlw1610c156e.It was observed that the limb had retracted back up into the right common iliac artery aneurysm.The physician implanted a limb at the level of the flow divider and down into the reia which resolved the endoleak.As per the physician the cause of the type ib endoleak was due to patients own anatomy as the physician stated that the graft lost seal because the rcia aneurysm was so large that it eventually pulled the limb out of the right external iliac artery back into the rcia causing the type ib endoleak.No additional clinical sequelae was provided and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 12967016
• Report Number: 9612164-2021-04774
• Device Sequence Number: 4332330
• Product Code: MIH
• UDI-Device Identifier: 00643169467637
• UDI-Public: 00643169467637
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

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: 07/16/2021
• Device Model Number: ETLW1610C156E
• Device Catalogue Number: ETLW1610C156E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/09/2021
• Date Device Manufactured: 07/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 78 KG