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

Model Number ESBF2814C103EE

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/21/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e tlw1624c93ee, serial/lot #: (b)(6), ubd: 15-feb-2026, udi#: (b)(4) ; product id: etlw1620c124ee, serial/lot #: (b)(6), ubd: 28-feb-2026, udi#: (b)(4).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

An endurant ii/iis stent graft system was implanted as part of the advance study for the treatment of abdominal aortic aneurysm.It was reported during the index procedure, left percutaneous access site bleeding occurred approx blood loss of 100cc.There was left access site complication due to incomplete hemostasis caused by the narrow and calcified femoral artery.No perforation was reported and no open conversion was required.The adverse event was resolved at the end of the procedure without prolonging hospitalization duration.No were no patient symptoms or injuries related to the event.The site and sponsor assessed the left percutaneous access site bleeding as having a causal relationship to the index procedure and not related to the study device or any underlying condition or disease.No additional clinical sequalae were provided and the patient is fine.

• Brand Name: ENDURANT IIS BIFURCATED 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: 19211326
• MDR Text Key: 341353880
• Report Number: 9612164-2024-02048
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

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 Model Number: ESBF2814C103EE
• Device Catalogue Number: ESBF2814C103EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/30/2024
• Date Device Manufactured: 01/10/2024
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 85 KG