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

Model Number	ETCF2828C49E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: e ttf2828c70e, serial/lot #: (b)(4), ubd: 13-sep-2018, udi#: (b)(4); product id: etcf2525c49e, serial/lot #: (b)(4), ubd: 02-oct-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Three endurant aortic cuffs were implanted during an unknown endovascular procedure.It was reported that a type ia endoleak was observed on an unknown date and re-intervention was carried out.An endurant lls stent graft system was implanted during an unknown endovascular procedure approximately 2.5 years post implant of the endurant cuffs.A valiant navion was then implanted at a different facility during an unknown endovascular procedure approximately 11 days later.No cause for the type ia as per the physician was provided.No additional clinical sequelae was provided and the patient will be monitored.

• Brand Name: ENDURANT II AORTIC 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: 14914463
• Report Number: 9612164-2022-02519
• Device Sequence Number: 17686216
• Product Code: MIH
• UDI-Device Identifier: 00613994991447
• UDI-Public: 00613994991447
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/05/2022

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: 07/06/2019
• Device Model Number: ETCF2828C49E
• Device Catalogue Number: ETCF2828C49E
• 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: 06/08/2022
• Initial Report FDA Received Date: 07/05/2022
• Date Device Manufactured: 07/06/2017
• 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: 87 YR
• Patient Sex: Female