BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK NEO¿

    MDR report key: 23598617 · Received November 19, 2025

    Report

    Report Number
    2024168-2025-11617
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 19, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    UDI-DI
    08717648232510
    PMA / PMN Number
    K220634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. THERE WAS NO LEAK NOTED DURING PREPARATION, WHICH SUGGESTS A PRODUCT QUALITY ISSUE DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IN THIS CASE, IT IS LIKELY THAT THE BALLOON INTERACTED WITH THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ANATOMY RESULTING IN THE REPORTED BALLOON RUPTURE DURING INFLATION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, 90% STENOSED, MODERATELY CALCIFIED, MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. DILATION WAS THEN PERFORMED USING A WOLVERINE 2.75X10MM. SUBSEQUENTLY, A 3.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED WITH NO RESISTANCE FELT DURING DELIVERY, HOWEVER, UPON THE FIRST INFLATION TO APPROXIMATELY 6 ATMOSPHERES, A RUPTURE WAS OBSERVED. IT IS BELIEVED THAT THE RUPTURE MAY HAVE BEEN CAUSED BY CONTACT WITH RESIDUAL NODULAR CALCIFICATION. THE DEVICE WAS REPLACED WITH A TASUKI 3.0X10MM, AND A 3.0X15MM XIENCE SKYPOINT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2556795 NC TREK NEO¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. 1400300-12 50430G1 08717648232510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown