BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO PGLA HLX

    MDR report key: 24020345 · Received January 9, 2026

    Report

    Report Number
    2029214-2026-00032
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    November 5, 2025
    Report Date
    January 9, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536045125
    PMA / PMN Number
    K090046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS AS FOUND CONDITION (CONDITION OF RETURNED DEVICE): THE CONCERTO DEVICES WERE ALL RETURNED WITHIN A SHIPPING BOX, INSIDE OF INDIVIDUAL OPENED CONCERTO OUTER CARTONS, OPENED INDIVIDUAL INNER POUCHES, AND WITH (B)(4) RETURNED ALONGSIDE A NON-MEDTRONIC MICROCATHETER. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE INTRODUCER SHEATH WAS FOUND TO BE APPLIED CORRECTLY WITH THE WAVELOCK FACING TOWARDS THE PROXIMAL END OF THE PUSHWIRE. THE PUSHWIRE WAS FOUND TO BE BENT WITHIN THE INTRODUCER SHEATH AT ~113.6CM AND BENT AT ~8.6CM FROM THE DISTAL END OF THE IMPLANT COIL. THE CONCERTO IMPLANT COIL WAS FOUND TO BE STRETCHED AND DAMAGED WITHIN THE INTRODUCER SHEATH. THE CONCERTO IMPLANT COIL WAS FOUND TO BE INTACT WITH THE PUSHWIRE DETACH ELEMENT; IN ADDITION, THE POLYPROPYLENE FILAMENT FOUND TO BE BROKEN OFF OF THE IMPLANT COIL; ALTHOUGH, STILL INTACT WITH THE PUSHWIRE DETACH ELEMENT. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS (INCLUDING SEM REPORTS):DURING TESTING, THE CONCERTO IMPLANT COIL WAS UNABLE TO ADVANCE OUTSIDE OF THE INTRODUCER SHEATH, DUE TO RESISTANCE ENCOUNTERED. DUE TO THE DAMAGED CONDITION OF THE IMPLANT COIL NO FURTHER TESTING WAS ABLE TO BE PERFORMED. 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 DEVICE WAS RETURNED DAMAGED WITH THE PUSHWIRE BENT IN MULTIPLE LOCATIONS. THE DAMAGE FOUND IS CONSISTENT WITH ADVANCEMENT AGAINST RESISTANCE. A FEW POSSIBLE CAUSES OF ¿ COIL RESISTANCE/STUCK IN CATHETER¿ ARE BUT NOT LIMITED TO TORTUOUS ANATOMY, INCOMPATIBLE CATHETER, AND DAMAGE OR KINK TO PUSHWIRE; HOWEVER, THE ROOT CAUSE FOR RESISTANCE COULD NOT BE DETERMINED. THE TRUSELECT MICROCATHETER USED IN THE PROCEDURE WAS RETURNED FOR ASSESSMENT. NO RESISTANCE WAS ABLE TO BE REPRODUCED WITHIN THE NON-MEDTRONIC MICROCATHETER, WHILE ADVANCING A 0.0165¿ MANDREL THOUGHT THE MICROCATHETER BODY. NO DETAILS (REF, LOT NUMBERS) WERE PROVIDED FOR THE MICROCATHETER; THEREFORE, COMPATIBILITY WAS UNABLE TO BE VERIFIED. IN ADDITION, THE SAME NON-MEDTRONIC MICROCATHETER WAS USED TO FINISH THE PROCEDURE WITHOUT FURTHER ISSUES. NO MENTION OF THE PATIENTS VESSEL TORTUOSITY WAS MENTIONED IN THE REPORT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. 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 THREE CONCERTO HELIX COILS (N=1 NV-2-8-HELIX, N=2 NV-3-8-HELIX) AND ONE CONCERTO 3D COIL (PV-3-8-3D) MET RESISTANCE\BECAME STUCK IN THE PROXIMAL END OF A NON-MEDTRONIC MICROCATHETER AND WERE UNABLE TO BE ADVANCED. THE IMPLANT COILS PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH AND THERE WAS NO DAMAGE TO THE COILS OR THE CATHETER. ADDITIONALLY, A CONCERTO HELIX COIL (NV-6-20-HELIX) MET RESISTANCE FROM THE POINT OF INITIAL ADVANCEMENT THROUGH THE SAME NON-MEDTRONIC MICROCATHETER AND WAS UNABLE TO BE ADVANCED PAST THE MIDDLE SECTION OF THE MICROCATHETER. UPON REMOVAL OF THE COIL, IT WAS OBSERVED THAT THE MIDDLE SEGMENT OF THE DELIVERY PUSHWIRE WAS KINKED. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE SAME MICROCATHETER WAS USED TO FINISH THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN ENDOLEAK. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED TRUSELECT¿ MICROCATHETER. ADDITIONAL INFORMATION RECEIVED THAT THE PROCEDURE WAS COMPLETED BY REPLACING WITH MEDTRONIC AND BOSTON COILS. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE CAUSE OF THE PUSHWIRE KINK WAS NOT DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE PLI30-NV-6-20-HELIX COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85735 CONCERTO PGLA HLX DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 PV-3-8-3D B796221 00847536045125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown