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

Model Number	ENLW1620C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis conclusion: the reported type ia and ib endoleak could not be confirmed on films provided; therefore, the cause of the events could not be determined.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.The post implant ct's received were non-contrast; therefore, no assessment of any endoleak, stent graft patency or thrombus could be performed.Angiograms (including endoleak interrogation) could allow for a more comprehensive determinations of the endoleak source/cause.It was reported by the physician that anatomical considerations , such as dilation of the aortic neck and iliac arteries were the cause of the reported endoleaks.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant bifurcated stent graft was implanted during an endovascular procedure for the treatment of an abdominal aortic aneurysm.  it was reported the the patient returned for a follow-up and a ct showed the presence of type ia and type ib endoleaks.  it was reported that the limb model model enlw1620c124e, implanted during the index procedure also contained an endoleak type ib, as per the physician.As per the physician, the cause of the type ia and ib endoleaks is due to continued dilatation of the aortic neck and common iliac arteries.No additional clinical sequelae was provided and the patient will be monitored.

• Brand Name: ENDURANT 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: 13976638
• Report Number: 9612164-2022-01282
• Device Sequence Number: 6370610
• Product Code: MIH
• UDI-Device Identifier: 00613994761910
• UDI-Public: 00613994761910
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2022

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: 03/30/2014
• Device Model Number: ENLW1620C124E
• Device Catalogue Number: ENLW1620C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2012
• 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
• Patient Age: 80 YR
• Patient Sex: Male