BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIUM HELIX

    MDR report key: 20216872 · Received September 13, 2024

    Report

    Report Number
    9617601-2024-00179
    Event Type
    Death
    Date Received
    September 13, 2024
    Date of Event
    June 8, 2023
    Report Date
    September 13, 2024
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    KRD
    UDI-DI
    00847536037458
    PMA / PMN Number
    K081465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT A PATIENT DEATH. THE PATIENT WAS UNDERGOING ANEURYSM TREATMENT, IMPLANTED SPRING COIL AND BLOOD FLOW DIVERSION DENSE MESH STENT. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNKNOWN ANEURYSM. ANEURYSM DIMENSIONS, BLOOD FLOW AND TORTUOSITY WAS UNKNOWN. THE CAUSE OF THE PATIENT¿S DEATH WAS UNKNOWN. IT WAS UNKNOWN IF DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS UNKNOWN. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DATE OF DEATH WAS UNKNOWN. THE CAUSE OF THE PATIENT¿S DEATH WAS UNKNOWN. NO EQUIPMENT MALFUNCTION DURING THE OPERATION WAS IDENTIFIED. IT WAS UNKNOWN IF THE PATIENT FOLLOWED THE DOCTOR'S INSTRUCTIONS AND TAKE RELEVANT MEDICATIONS AFTER THE OPERATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS BEING TREATED FOR AN INTERNAL CAROTID ARTERY ANEURYSM NEAR THE INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY. THE CAUSE OF DEATH WAS UNKNOWN. THE FULL PROCEDURE, COMPLICATIONS DURING THE PROCEDURE AND WHEN THE PATIENT DIED WAS UNKNOWN. THE POST PROCEDURE ANGIOGRAPHIC RECORD WAS NOT AVAILABLE. IT WAS UNKNOWN IF ANY MEDTRONIC DEVICES WERE RESPONSIBLE FOR THE PATIENT¿S DEATH, DOCTORS FOLLOWING ORDER OR IF WAS DAPT TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101486 AXIUM HELIX DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MEDTRONIC MEXICO S. DE R.L. DE CV QC-7-30-HELIX 225062439 00847536037458

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Death