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

Model Number	ETLW1616C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/02/2022
Type of Reportable Event	Death
Event or Problem Description
An endurant iis bifurcated stent graft was implanted during an endovascular procedure for the treatment of a ruptured 50mm abdominal aortic aneurysm.  it was reported via the post procedure angiogram that there was a presence of a type ia endoleak.The physician re-ballooned the proximal aorta but the type ia persisted.  it was reported 2 days later, the patient underwent an open exploratory abdominal repair.The blood loss and prolonged hypotension led to multi-system failure and the patient expired.No cause of the type ia endoleak was provided.No cause of the type ia endoleak was provided.  no additional clinical sequelae was provided and the patient is fine.
Additional Manufacturer Narrative
Concomitant medical products other relevant device(s) are: product id: e tlw1613c156e, serial/lot #: (b)(4), ubd: 14-jan-2023, udi#: (b)(4); product id: etlw1613c146e, serial/lot #: (b)(4), ubd: 17-aug-2023, udi#: (b)(4); product id: etlw1613c146e, serial/lot #: (b)(4), ubd: 29-jun-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• 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: 14511996
• Report Number: 9612164-2022-02015
• Device Sequence Number: 16799067
• Product Code: MIH
• UDI-Device Identifier: 00643169467675
• UDI-Public: 00643169467675
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/26/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2023
• Device Model Number: ETLW1616C124E
• Device Catalogue Number: ETLW1616C124E
• 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: 05/04/2022
• Initial Report FDA Received Date: 05/26/2022
• Date Device Manufactured: 10/29/2021
• 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: Other; Required Intervention; Death
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 95 KG