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

Model Number	ETBF2816C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis conclusion: the reported type ib endoleak of the right limb was confirmed on the films provided; however the type ia endoleak could not be confirmed.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.Angiograms (including endoleak interrogation) could allow for a more comprehensive determinations of the endoleak source/cause.It most likely that the proximal endoleak was a type ia, but this could not be fully confirmed from the limited films available.Disease progression, as noted per the physician, with aneurysm morphology changes over the time of implant of the devices may have been a factor in the occurrence of the reported events.It is also possible that the aneurysmal right common iliac artery was being pressurized via the marginal distal seal.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft was implanted in a patient for the endovascular treatment of an 30mm iliac aortic aneurysm it was reported follow up ct identified a type ib endoleak with aneurysm growth in the internal iliac.Intervention was completed with coiling of the hypogastric artery and the limb was extended into the internal artery and the endoleak was resolved.It was reported that a type ia endoleak was also identified on the bifurcate graft on the same day of the intervention.Endoanchors were implanted at rao of 35 and lao on both sides of graft and the endoleak resolved.The physician believes that the graft was properly sized during the initial procedure during initial procedure and the cause of the type ia endoleak was due to progression of aneurysmal disease.Per physician the cause of the type ib endoleak was anatomy related where the aneurysm grew.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT II BIFURCATED 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: 13891525
• Report Number: 9612164-2022-01158
• Device Sequence Number: 1713740
• Product Code: MIH
• UDI-Device Identifier: 00613994991133
• UDI-Public: 00613994991133
• 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: 2014
• 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): 03/24/2022

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: 05/21/2016
• Device Model Number: ETBF2816C166E
• Device Catalogue Number: ETBF2816C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2014
• 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