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

Model Number ESBF2814C103E

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 04/15/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

An endurant iis bifurcate stent graft system was implanted in the urgent endovascular treatment of an unknown sized ruptured abdominal aortic aneurysm.It was reported that during the index procedure the patient "coded" as the emergent evar treatment was in progress.The patient expired due to the ruptured aaa.No additional clinical sequelae were provided and the patient is expired.

Manufacturer Narrative

Additional information received.It was reported that the death was not device related as per the physician.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT IIS BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 9976952
• MDR Text Key: 188196648
• Report Number: 9612164-2020-01610
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439979
• UDI-Public: 00643169439979
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2022
• Device Model Number: ESBF2814C103E
• Device Catalogue Number: ESBF2814C103E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2020
• Initial Date FDA Received: 04/20/2020
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 05/25/2020
• Date Device Manufactured: 01/23/2020
• 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): Death
• Patient Age: 87 YR