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

Model Number ESBF2814C103E

Device Problem No Apparent Adverse Event (3189)

Patient Problems Death (1802); Disseminated Intravascular Coagulation (DIC) (1813); Blood Loss (2597)

Event Date 05/23/2020

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: etlw1620c124e, serial/lot #: (b)(4), ubd: 11-feb-2022, udi#: (b)(4); product id: etlw1620c124e, serial/lot #: (b)(4), ubd: 05-mar-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant iis stent graft system was implanted in the patient for the endovascular treatment of an unknown sized abdominal aortic aneurysm.It was reported that the family of the patient was notified the next day that the patient was losing a lot of blood and would be going back to surgery.The family was later informed that the patient died from complications.The patients registration card had a misprint in the patient's date of birth.The cause of the events was not determined.No additional clinical sequelae were reported.

Manufacturer Narrative

It was reported as per the physician that the blood loss was not related to the endograft, it was reported the patient possibly went into dic, as per the physician none of the implanted devices or procedure were related to the blood loss or pt death.Cause of death per physician was hemorrhage.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: 10199615
• MDR Text Key: 196552254
• Report Number: 9612164-2020-02331
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439979
• UDI-Public: 00643169439979
• Combination Product (y/n): N
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2022
• Device Model Number: ESBF2814C103E
• Device Catalogue Number: ESBF2814C103E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2020
• Date Device Manufactured: 02/25/2020
• 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: 83 YR