BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 21692843 · Received March 25, 2025

    Report

    Report Number
    1220648-2025-26951
    Event Type
    Death
    Date Received
    March 25, 2025
    Date of Event
    February 27, 2025
    Report Date
    April 25, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF VASCULAR DAMAGE - PERIPHERAL VESSEL HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT ADDITIONAL CLINICAL DETAILS, THE ROOT CAUSE OF THE REPORTED ISSUES COULD NOT BE DETERMINED. E4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26951 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. G1 REPORTING CONTACT FACILITY NAME AND FAX NUMBER WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26951. H6 HEALTH EFFECT - IMPACT CODE 4641 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26951.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 25 MAR 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. THE COMPLAINT OF "SPONTANEOUS XXX ETCO2 MODULE ON SCREEN" REGARDING PARTS 301-5107ET AND 301-5707F-SE WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED BUT COULD POSSIBLY BE A RESULT OF USER ERROR. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE ESCALATION TO THE CAPA REVIEW BOARD. THERE HAVE BEEN 9 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WILL NOT BE RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. THE INSTRUCTIONS FOR USE FOR THE IMPELLA 5.5 WITH SMART ASSIST FOR USE DURING CARDIOGENIC SHOCK STATES THE FOLLOWING: SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES) ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION)¿.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED VIA ABIOMED¿S LONG-TERM OUTCOME AND QUALITY INDICATOR (LOQI) IMPELLA REGISTRY THAT THE PATIENT ENDURED AN ACUTE KIDNEY INJURY (AKI) DURING IMPELLA SUPPORT. THE AKI WAS BELIEVED TO HAVE A POSSIBLE RELATIONSHIP TO THE IMPELLA DEVICE. CONTINUOUS RENAL REPLACEMENT THERAPY WAS INITIATED TO TREAT THE CONDITION.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 64 YEAR OLD MALE PATIENT DEVELOPED A GASTROINTESTINAL BLEED DURING IMPELLA 5.5 SUPPORT. HEPARIN WAS BEING RUN THROUGH THE PURGE LINE AT THE TIME OF THE BLEED AND ANTICOAGULANTS WERE HALTED TO MANAGE THE CONDITION. SUPPORT CONTINUED UNINTERRUPTED. NINE DAYS LATER, THE FAMILY MADE THE DECISION TO WITHDRAW CARE AND THE PATIENT PASSED AWAY. THERE IS NOT ENOUGH EVIDENCE TO DISASSOCIATE THE DEATH WITH THE USE OF THE IMPELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695700 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025539647 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death| R