BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO PGLA HLX

    MDR report key: 24618934 · Received March 17, 2026

    Report

    Report Number
    2029214-2026-00452
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    December 8, 2025
    Report Date
    March 17, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536045071
    PMA / PMN Number
    K090046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 PRODUCT ANALYSIS: AS FOUND CONDITION (CONDITION OF RETURNED DEVICE): THE CONCERTO DEVICE WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, A SEALED PLASTIC BIOHAZARD POUCH, AN OPENED CONCERTO OUTER (B801365) CARTON, AN OPENED CONCERTO INNER POUCH (B801365), A RESEALABLE PLASTIC BAG, AND WITHIN AN INTRODUCER SHEATH. NO MICROCATHETER WAS RETURNED. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: NO INTRODUCER SHEATH WAS RETURNED. THE PUSHWIRE WAS FOUND TO BE BENT AT ~6.1M, DAMAGED (TWISTED) AT ~153.6CM, AND DAMAGED DISTAL TO THE DETACH ELEMENT FROM THE PROXIMAL END. THE CONCERTO IMPLANT COIL WAS FOUND TO BE BROKEN OFF AND NOT RETURNED. THE DETACH ELEMENT WAS FOUND TO BE STILL INTACT WITH THE PUSHWIRE. THE SHIELD COIL WAS FOUND TO BE DAMAGED. THE COIN WAS FOUND TO BE RETRACTED FROM THE LUMEN STOP. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS (INCLUDING SEM REPORTS): NONE. CONCLUSION: BASED ON THE DEVICE ANALYSIS AND THE REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿COIL RESISTANCE/STUCK IN CATHETER¿ WAS ABLE TO BE CONFIRMED, AS THE CONCERTO DEVICE WAS RETURNED WITH THE PUSHWIRE BENT, DAMAGED, AND THE IMPLANT COIL BROKEN OFF AND NOT RETURNED. THE DAMAGE FOUND WITH THE CONCERTO DEVICE WAS FOUND TO BE CONSISTENT WITH ADVANCEMENT AGAINST RESISTANCE. NO IMPLANT COIL WAS RETURNED FOR ASSESSMENT; THEREFORE, ANY CONTRIBUTION THE IMPLANT COIL HAD TOWARDS THE RESISTANCE/BREAK WAS UNABLE TO BE ASSESSED. A FEW POSSIBLE CAUSE OF CATHETER RESISTANCE ARE BUT NOT LIMITED TO, INCOMPATIBLE CATHETER, DAMAGE OR KINK TO PUSHWIRE, AND/OR USER DOES NOT MAINTAIN CONTINUOUS FLUSH; HOWEVER, THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. BASED ON THE DEVICE ANALYSIS AND THE REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿COIL RESISTANCE/STUCK IN SHEATH¿ WAS UNABLE TO BE CONFIRMED. NO INTRODUCER SHEATH WAS RETURNED FOR ASSESSMENT. ANY CONTRIBUTION THE INTRODUCER SHEATH HAD TOWARDS THE RESISTANCE/BREAK WAS UNABLE TO BE ASSESSED. THE REPORT NOTES THAT ¿CONCERTO COIL HAD RESISTANCE/WAS STUCK IN THE SHEATH. FURTHERMORE, IT WAS REPORTED THAT THE COIL BECAME ENTANGLED WITH THE MICROCATHETER AND DAMAGED IT.¿. THE NON-MEDTRONIC (PROGRADE 2.4 FR) MICROCATHETER MENTIONED IN THE PROCEDURE WAS NOT RETUR NED; THEREFORE, THE CONDITION OF THE CATHETER WAS UNABLE TO BE ASSESSED. ANY CONTRIBUTION THE CATHETER HAD TOWARDS THE DAMAGE/RESISTANCE WAS UNABLE TO BE VERIFIED. COMPATIBILITY CANNOT BE CONFIRMED AS NO LOT OR REFERENCE NUMBERS WERE PROVIDED FOR THE NON-MEDTRONIC CATHETER. IT WAS REPORTED THAT THE CONCERTO COIL WAS PREPARED; ALTHOUGH, DURING PREPARATION, THE INTRODUCER SHEATH WAS NOT HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION; THE DEVICE WAS HELD HORIZONTALLY. 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 REPORT REGARDING CONCERTO COIL THAT HAD RESISTANCE/WAS STUCK IN THE SHEATH. FURTHERMORE, IT WAS REPORTED THAT THE COIL BECAME ENTANGLED WITH THE MICROCATHETER AND DAMAGED IT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. (B)(6) 2026 E1 (REP, HCP, FOR): ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING PREPARATION, THE INTRODUCER SHEATH WAS NOT HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION; THE DEVICE WAS HELD HORIZONTALLY. THE COIL NEVER ENTERED THE MICROCATHETER OR THE PATIENT'S BODY. THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ANCILLARY DEVICE: TERUMO PROGREAT 2.4F CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677309 CONCERTO PGLA HLX DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 PV-2-2-3D B801365 00847536045071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown