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

Model Number	ETBF2516C124E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant iis bifurcated stent graft was implanted for the endovascular treatment of an abdominal aortic aneurysm.  it was reported during the index procedure the endurant iis was implanted with no issues.The physician then attempted to implant a limb but instead began implanting a 25x16x124 endurant ii bifurcated stent graft as the wrong device was opened by the rep. the bifurcated graft was placed in the gate as if it were the correct limb.Too much of the graft had been deployed to recapture or pull it out before the physician noticed it was the wrong graft.The physician decided to continue deploying the bifurcated graft inside the gate of the original graft(23x14x103).The suprarenal struts we¿re about 7mm about the level of the graft bifurcation.The gate opened inside the common iliac artery.A 10x37 bare metal stent was placed in the ipsilateral limb of the 25x16x124 graft at the level of the contra lateral gate.The gate was crushed against the common iliac wall.This left the ipsilateral limb patent.The other limb of the original graft was deployed with no issue.After ballooning both common iliac limbs an angiogram was performed.Both limbs were patent and no endoleak was present.As per the physician the cause of the event was due to the wrong graft being opened and not realizing until it had been deployed no additional clinical sequalae 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 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: 15201537
• Report Number: 9612164-2022-03017
• Device Sequence Number: 17755142
• Product Code: MIH
• UDI-Device Identifier: 00613994991256
• UDI-Public: 00613994991256
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/10/2022

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: 04/22/2023
• Device Model Number: ETBF2516C124E
• Device Catalogue Number: ETBF2516C124E
• 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: 08/03/2022
• Initial Report FDA Received Date: 08/10/2022
• Date Device Manufactured: 04/22/2021
• 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: 75 YR
• Patient Sex: Male