BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24939300 · Received April 21, 2026

    Report

    Report Number
    1220648-2026-06999
    Event Type
    Death
    Date Received
    April 21, 2026
    Date of Event
    April 14, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013344
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2 AND A4 ARE UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    D4. CATALOG, SERIAL AND PRIMARY UDI NUMBER CORRECTED.

    Description of Event or Problem · 0

    AN IMPELLA CPSA C9 DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A MALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), TRIPLE VESSEL CORONARY ARTERY DISEASE (CAD), ELEVATED LACTATE LEVELS, HYPOTENSIVE, IN SCAI STAGE D SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI) AND AS A BRIDGE TO A HEART TRANSPLANT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) FOR ABOUT TWO DAYS POST IMPELLA IMPLANT, THE PATIENT WAS SEDATED AND INTUBATED FOR RESPIRATORY SUPPORT. THE PATIENT HAD MULTIPLE DIAGNOSTIC STUDIES, INCLUDING CHEST X-RAYS AND TOTAL BODY COMPUTED TOMOGRAPHY (CT) SCANS, AS PART OF THE TRANSPLANT WORK-UP. IT WAS NOTED THAT THERE WAS A CRACKED PURGE RESERVOIR CAUSING ALARMS. TROUBLESHOOTING WAS ATTEMPTED BY USING A NEEDLE AND AN AMBER COLORED CABLE TO CREATE AN ALTERNATIVE PURGE SYSTEM. DURING TROUBLESHOOTING, THE PURGE PRESSURE, WHICH HAD PREVIOUSLY INCREASED TO APPROXIMATELY 900 MMHG, DECREASED TO APPROXIMATELY 400¿500 MMHG, WITH A REPORTED PURGE FLOW OF ABOUT 11 ML/HR. THE PUMP SUPPORT LEVEL WAS REDUCED TO P-5 TO P-6 IN ORDER TO DECREASE MOTOR CURRENT. PURGE FLOW WAS TEMPORARILY RE-ESTABLISHED AND THE ALARMS RESOLVED. APPROXIMATELY SIX HOURS LATER, THE PUMP SUDDENLY STOPPED AND TRANSITIONED TO P-0. AT THAT POINT, THE PHYSICIAN DECIDED TO REPLACE THE PUMP. ONE HOUR LATER, THE IMPELLA WAS EXCHANGED FOR A NEW IMPELLA CP. AT THE TIME OF RE-IMPLANTATION, THE PATIENT WAS REPORTED TO HAVE NO NATIVE CARDIAC ACTIVITY WITH A SIGNIFICANT DETERIORATION OF RENAL FUNCTION. SHORTLY AFTER, THE PATIENT PASSED AWAY. THE IMPELLA IS CONSERVATIVELY BEING REPORTED FOR DEATH; HOWEVER, IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE UNDERLYING CLINICAL CONDITION OF A CRITICALLY ILL PATIENT IN ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, COMPLICATED BY STAGE D SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270583 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026751516 00813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death