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

Model Number	ETLW1616C93E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2021
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
Endurant ii stent graft system was implanted during an endovascular procedure for the treatment of a 50mm abdominal aortic aneurysm.It was reported during a follow-up visit approximately 5 years post the index procedure that the right limb had pulled out of the common iliac artery with loss of seal and the left limb had loss of seal with roughly 1cm of seal and no endoleaks seen.Intervention was completed.The physician placed a 16 x 13 x 156 limb extending the right side from the flow divider all the way down to seal in the right external iliac artery.The right hypogastric artery was coiled prior to the limb implant.The left side was also extended completely to the left hypogastric artery with a 16 x 24 x 124 limb.The final angio showed perfect results.As per the physician the cause of the event cannot be determined.No additional clinical sequelae was provided and the patient is fine.

• 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: 12932682
• Report Number: 9612164-2021-04706
• Device Sequence Number: 17554575
• Product Code: MIH
• UDI-Device Identifier: 00643169467569
• UDI-Public: 00643169467569
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 12/06/2021

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: 07/05/2018
• Device Model Number: ETLW1616C93E
• Device Catalogue Number: ETLW1616C93E
• 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: 11/15/2021
• Initial Report FDA Received Date: 12/06/2021
• Date Device Manufactured: 07/05/2016
• 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: 84 YR
• Patient Sex: Male