BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWAN-GANZ CATHETER UNKNOWN

    MDR report key: 12085692 · Received June 29, 2021

    Report

    Report Number
    2015691-2021-03817
    Event Type
    Death
    Date Received
    June 29, 2021
    Date of Event
    April 15, 2021
    Report Date
    September 23, 2021
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K040287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    9/22/21: CORRECTION TO H1 FROM SERIOUS INJURY TO DEATH. THIS CORRECTION IN THIS SUPPLEMENTAL IS BEING DONE BECAUSE THE PATIENT EXPIRED FROM PROFOUND HYPOTENSION. THE INITIAL MDR HAD SECTION H1 MARKED AS SERIOUS INJURY, BUT THE PATIENT ULTIMATELY EXPIRED. IT IS KNOWN THAT THE SUTURES FOR THE VALVE WERE SEWN INTO THE CATHETER, WHICH CAUSED BLEEDING UPON REMOVAL OF THE CATHETER. IT IS NOT KNOWN IF THE BLEEDING FROM THE REMOVAL OF THE CATHETER WAS RESPONSIBLE FOR THE DEATH OF THE PATIENT. DUE TO THE DEATH OF THE PATIENT A CORRECTION IS BEING SUBMITTED TO CONVEY THE CORRECT INFORMATION THAT HAPPENED TO THE PATIENT IN SECTION H1.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION; IT WAS DISCARDED AT THE HOSPITAL. WITHOUT THE RETURN OF THE PRODUCT, IT IS NOT POSSIBLE TO DETERMINE IF DAMAGES OR DEFECTS EXISTED ON THE PRODUCT. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    PER RECEIVED MEDICAL RECORDS, THE PATIENT PRESENTED WITH WORSENING SHORTNESS OF BREATH. PRE-OP TEE SHOWED AN EJECTION FRACTION OF 50%, MODERATE AS, THE VALVE WAS ROCKING WITH SEVERE PVL, AND MODERATE-SEVERE MR. THE PATIENT UNDERWENT REDO AORTIC VALVE REPLACEMENT AND MITRAL VALVE REPAIR WITH A NON-EW RING. DIRECT INSPECTION OF THE AORTIC VALVE FOUND IT WAS ONLY HELD BY APPROXIMATELY HALF THE SUTURES. THE ENTIRE LEFT COMMISSURE AND THE RIGHT LEFT COMMISSURE HAD DEHISCED. THE VALVE WAS EXCISED, A 23MM INSPIRIS VALVE WAS IMPLANTED AND TIED DOWN WITH THE COR-KNOT DEVICE. POST-OP ECHO SHOWED GOOD EJECTION FRACTION, TRIVIAL PERIVALVULAR LEAK, AND NOT MUCH REGURGITATION. THERE WERE SIGNIFICANT DIFFICULTIES AT THE END OF THE CASE AS THE SWAN GANZ CATHETER WAS SEWN ON AS THE INNOMINATE VEIN WAS OVERSEWED. UPON REMOVAL OF THE CATHETER SIGNIFICANT BLEEDING OCCURRED. OVERALL, THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. POSTOPERATIVELY THE PATIENT HAD COMPLICATIONS OF AKI, ARDS, AND RESPIRATORY FAILURE. ON POD # 4, THE PATIENT DEVELOPED PROFOUND HYPOTENSION, CODED AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982555 SWAN-GANZ CATHETER UNKNOWN SWAN-GANZ CATHETER DYG EDWARDS LIFESCIENCES, PR SWAN GANZ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| L| R