BEUDAMED
    FDA Adverse Event Death Summary report: N

    APERTA NSE CORONARY DILATATION CATHETER

    MDR report key: 24797483 · Received April 7, 2026

    Report

    Report Number
    3007835716-2026-00036
    Event Type
    Death
    Date Received
    April 7, 2026
    Date of Event
    March 16, 2026
    Manufacturer
    NIPRO VASCULAR CORPORATION
    Product Code
    NWX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, IT WAS NOT POSSIBLE TO CONDUCT A DETAILED INVESTIGATION OF THE PRODUCT. IT IS CONSIDERED THAT THE REPORTED EVENT WAS ASSOCIATED WITH A CALCIFIED LESION, WHICH MAY HAVE CONTRIBUTED TO BALLOON RUPTURE AND VESSEL DAMAGE DURING PRODUCT EXPANSION. HOWEVER, THE DETAILED ROOT CAUSE COULD NOT BE DETERMINED. NO ABNORMALITIES WERE FOUND ON THE PRODUCTION RECORDS. 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

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE BALLOON WAS USED TO TREAT A 90% STENOTIC, TORTUOUS, AND CALCIFIED LESION IN SEGMENT #2 OF THE RCA AND INITIALLY EXPANDED WITHOUT ANY ISSUES. HOWEVER, WHILE THE BALLOON WAS INFLATED AT 20 ATM, IT RUPTURED, RESULTING IN VASCULAR INJURY, AND THE PATIENT SUBSEQUENTLY EXPERIENCED CARDIAC ARREST. PCPS AND IABP WERE USED, FOLLOWED BY A PERFUSION BALLOON, WHICH WAS THEN INFLATED FOR MORE THAN 20 MINUTES IN AN ATTEMPT TO ACHIEVE HEMOSTASIS. HOWEVER, ADEQUATE HEMOSTASIS COULD NOT BE ACHIEVED. CONSEQUENTLY, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. AT THE RECEIVING HOSPITAL, BYPASS SURGERY WAS PERFORMED FOR RITA-RCA AND LITA-LAD. THE PATIENT'S CONDITION IMPROVED AT THAT POINT; HOWEVER, ON THE FOLLOWING DAY, THE RITA-RCA WAS REOCCLUDED AND THE PATIENT'S CONDITION DETERIORATED AGAIN. ALTHOUGH BYPASS GRAFTING WAS PERFORMED AGAIN, NO IMPROVEMENT WAS OBSERVED, AND PCPS WAS USED. HOWEVER, THE PATIENT'S CONDITION DID NOT IMPROVE THEREAFTER, AND THE PATIENT PASSED AWAY ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858785 APERTA NSE CORONARY DILATATION CATHETER Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring NWX NIPRO VASCULAR CORPORATION APN32513 ANH250403B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| D| H