BEUDAMED
    FDA Adverse Event Death Summary report: N

    P9 IMPELLA SWAN CL

    MDR report key: 22554479 · Received July 21, 2025

    Report

    Report Number
    MW5172995
    Event Type
    Death
    Date Received
    July 21, 2025
    Date of Event
    October 15, 2023
    Report Date
    July 16, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023, 76-YEAR-OLD (B)(6) WALKED INTO (B)(6) HOSPITAL, LOCATED AT (B)(6) COMPLAINING OF SHORTNESS OF BREATH. WITHIN MINUTES HE WAS DIAGNOSED WITH A CONGESTIVE HEART FAILURE EXACERBATION AND WAS SCHEDULED FOR A CATHETERIZATION THE NEXT DAY DUE TO FLUID SURROUNDING HEART AND LUNGS. HE WAS GIVEN THE DRUG LASIX TO HELP. IT WAS DELAYED ANOTHER DAY DUE TO WAITING FOR FLUID TO DRAIN. DR. (B)(6) PERFORMED THE CATHETERIZATION AROUND 11AM AND CAME TO THE CONCLUSION THERE WERE NO BLOCKAGES, AND IT WAS NOT A "HEART PROBLEM." HIS HOSPITALIZATION THEN BECAME COMPLICATED BY CARDIOGENIC SHOCK AND TRANSFERRED TO INTENSIVE CARE UNIT. ON (B)(6), NEPHROLOGY WAS CONSULTED, DIURETICS WERE STOPPED, AND THEY ARE STARTED CRRT AND PRESSOR THERAPY. THIS DIALYSIS WAS SUPPOSED TO BE TEMPORARY. HE HAD SUSTAINED V TACH ON (B)(6) REQUIRING BRIEF CPR, SUBSEQUENT DEFIBRILLATION, THEN INTUBATION; ALSO TEMPORARY. HE WENT IN FOR ANOTHER CATHETERIZATION WITH DR. (B)(6), WHO FOUND FIVE BLOCKAGES AND PLACED FIVE STENTS. HE THEN PLACED THE IMPELLA SUPPORTED PCI. ON (B)(6) HIS COLORING WAS GOOD AND ACCORDING TO THE NURSE ON DUTY, HE WAS TRENDING POSITIVE. WHEN I ARRIVED ON (B)(6) HIS COLORING WAS GRAY, HIS BLOOD WAS PURPLE/BROWN, AND I HAD NOTICED THAT HIS BANK OF MONITORS HAD BEEN CHANGED AND WERE PLUGGED IN ON THE OTHER SIDE OF THE ROOM. SOON AFTER, THE DOCTORS WERE LEADING ME BY THE ARM TO A QUIET PLACE TO TELL ME I NEEDED TO MAKE A DECISION OF WHETHER OR NOT TO TAKE HIM OFF OF LIFE SUPPORT, AS HE WAS GETTING WORSE, AND THERE WAS NO HOPE FOR HIM. AFTER CONSULTING WITH FAMILY, THE DECISION WAS MADE TO TAKE HIM OFF OF LIFE SUPPORT. HE DIED WITHIN MINUTES ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037403 P9 IMPELLA SWAN CL TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death ALOGLIPTIN, | ALTORVASTATIN| EZETIMIBE| GLIMEPIRIDE| ISOSORBIDE MONONITRATE| MEPOTROLO SUCCINATE | MEPOTROLO SUCCINATE, ANDISOSORBIDE MONONITRATE| METFORMIN