BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25191991 · Received May 15, 2026

    Report

    Report Number
    1220648-2026-07926
    Event Type
    Death
    Date Received
    May 15, 2026
    Date of Event
    May 11, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IMPELLA 5.5 WAS INSERTED VIA RIGHT AXILLARY IN A PATIENT OF 68-YEAR-OLD MALE FOR A CARDIOMYOPATHY INDICATION. THE PATIENT¿S COMORBIDITIES WERE PRIOR CORONARY ARTERY BYPASS GRAFT SURGERY, KNOWN CORONARY ARTERY DISEASE, AND RENAL INSUFFICIENCY. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK STAGE D. DURING THE COURSE OF SUPPORT, THE PATIENT EXPERIENCED CONTINUOUS SUCTION ALARMS AT PERFORMANCE LEVELS ABOVE P4. ASSESSMENT OF THE DEVICE CONFIRMED THAT THE IMPELLA POSITION WAS APPROPRIATE. EVALUATION OF PRELOAD STATUS WAS LIMITED, AS A PULMONARY ARTERY CATHETER WAS NOT IN PLACE. THE CLINICAL PRESENTATION WAS FURTHER COMPLICATED BY PRE-EXISTING RIGHT VENTRICULAR DYSFUNCTION AND SEVERE MITRAL REGURGITATION. NO LABORATORY VALUES OR ADDITIONAL DIAGNOSTIC TEST RESULTS WERE PROVIDED. NO SPECIFIC TROUBLESHOOTING ACTIONS OR INTERVENTIONS TO RESOLVE THE SUCTION ALARMS WERE DOCUMENTED. THE POST PROCEDURE OUTCOME WITHDRAWAL OF CARE ON DAY 28 OF SUPPORT, BEYOND THE PUMPS INDICATION OF USE. THE RELATIONSHIP BETWEEN THE IMPELLA 5.5 DEVICE PERFORMANCE AND THE PATIENT OUTCOME CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION AND IS MORE LIKELY ATTRIBUTABLE TO THE PATIENT¿S UNDERLYING CLINICAL CONDITION, INCLUDING ADVANCED CARDIOMYOPATHY, RIGHT VENTRICULAR DYSFUNCTION, AND SEVERE MITRAL REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166078 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026785114 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death| R