BEUDAMED
    FDA Adverse Event Death Summary report: N

    APERTA NSE CORONARY DILATATION CATHETER

    MDR report key: 22049479 · Received May 20, 2025

    Report

    Report Number
    3007835716-2025-00051
    Event Type
    Death
    Date Received
    May 20, 2025
    Manufacturer
    GOODMAN CO., LTD.
    Product Code
    NWX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED AND THERE WAS NOT ENOUGH INFORMATION AVAILABLE. THEREFORE, IT WAS NOT POSSIBLE TO CONDUCT A DETAILED INVESTIGATION OF THE PRODUCT OR TO CHECK THE MANUFACTURING AND INSPECTION RECORDS. IT IS CONSIDERED THAT THE CONDITION OF THE LESION INFLUENCED THIS INCIDENT, LEADING TO DAMAGE TO THE BLOOD VESSELS WHEN THE PRODUCT WAS EXPANDED, BUT THE DETAILED CAUSE COULD NOT BE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDE GENERAL INSTRUCTIONS FOR USE, WARNINGS AND PRECAUTIONS RELATED TO THE DEVICE, AND INFORMATION TO MAKE USERS AWARE OF POTENTIAL COMPLICATIONS AND OTHER EVENTS SIMILAR TO THIS EVENT THAT MAY OCCUR. THIS REPORT DOES NOT IMPLY AN ADMISSION BY ANYONE THAT THE PRODUCTS MENTIONED IN THIS REPORT ARE DEFECTIVE.

    Description of Event or Problem · 0

    THE PATIENT WITH A SYMPTOM OF CHEST PAIN AT REST, AN EMERGENT CAG WAS DONE, AND IT REVEALED A SEVERE STENOSIS OF THE RIGHT CORONARY ARTERY WITH DELAYED FLOW AND A SEVERE STENOSIS OF THE MIDDLE PART OF THE LEFT ANTERIOR DESCENDING AND THE OBTUSE MARGIN BRANCH. THE RIGHT CORONARY ARTERY LESION WAS JUDGED TO BE THE CULPRIT SITE, AND THE REVASCULARIZATION FOR THE RIGHT CORONARY ARTERY WAS PERFORMED. BECAUSE THE CARDIAC FUNCTION OF THE PATIENT WAS VERY LOW AND THE SYMPTOM OF HEART FAILURE WAS PERSISTENT, THE ADDITIONAL INTERVENTION FOR THE MIDDLE PART OF THE LEFT ANTERIOR DESCENDING AND OBTUSE MARGINAL BRANCH WAS PERFORMED 2 DAYS AFTER THE FIRST INDEX PROCEDURE. A DRUG-COATED BALLOON (DCB) WAS USED FOR TREATING THE LEFT ANTERIOR DESCENDING LESION AND A GOOD ANGIOGRAPHICAL RESULT WAS OBTAINED. THEN, PCI FOR THE OBTUSE MARGINAL BRANCH WAS PERFORMED, AND THE PRE-PROCEDURAL IVUS IMAGE SHOWED AN ECCENTRIC, APPROXIMATELY 270-DEGREE, CALCIFIED PLAQUE AND A THIN PLAQUE AT THE RESIDUAL SITE, WHOSE LENGTH WAS 6.1 MM. PRE-DILATION USING A APERTA NSE CORONARY DILATATION CATHETER (APN25013) WAS PERFORMED AT NOMINAL PRESSURE AND THE VASCULAR RUPTURE WAS SEEN. THEREFORE, THE COVERED STENT WAS IMMEDIATELY IMPLANTED IN THE OBTUSE MARGINAL BRANCH. FINALLY, A COMPLETE REVASCULARIZATION FOR THE LEFT ANTERIOR DESCENDING AND OBTUSE MARGINAL BRANCH WERE ACCOMPLISHED, THE PATIENT DIED OF NON-OCCLUSIVE MESENTERIC ISCHAEMIA DURING THE PERIOD OF HOSPITALIZATION. A TEMPORARY DECREASE IN BLOOD PRESSURE DURING PCI MAY PARTIALLY EXPLAIN THIS DEVASTATING EVENT. THIS INFORMATION IS TAKEN FROM THE LITERATURE. (EUROPEAN HEART JOURNAL - CASE REPORTS (2023) 7, 1-5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050084 APERTA NSE CORONARY DILATATION CATHETER Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring NWX GOODMAN CO., LTD. APN25013 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D