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

Model Number ETLW1620C146E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Rupture (2208)

Event Date 01/21/2022

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant bifurcated stent graft was implanted during 90 mm abdominal aortic aneurysm.It was reported the patient presented to the emergency room under a year later, a ct was carried out and evidence of a type i endoleak and ruptured abdominal aortic aneurysm was observed.The physician carried out emergency surgery and the patient expired during the procedure.It was reported that both type ia and type ib endoleak were observed.It is believed that the type lb endoleak is coming around the etlw1613c156e sn (b)(4) as per the physician the cause of death was as a result of a pulmonary embolism.No additional clinical sequalae was provided and the patient had expired.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Type of Device: 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: 13590056
• MDR Text Key: 286041480
• Report Number: 9612164-2022-00768
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00763000388997
• UDI-Public: 00763000388997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: ETLW1620C146E
• Device Catalogue Number: ETLW1620C146E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/24/2022
• Date Device Manufactured: 11/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death; Other
• Patient Age: 69 YR
• Patient Sex: Female