BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 25028371 · Received April 29, 2026

    Report

    Report Number
    1220648-2026-07229
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    December 5, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G3 AFTER A CROSS-FUNCTIONAL REVIEW, IT WAS DETERMINED THAT A REPORT AGAINST THE PUMP WAS NEEDED AS IT MAY HAVE CONTRIBUTED TO THE REPORTED PLACEMENT SIGNAL ISSUE. THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENTS THE PUMP AND ANOTHER REPORT WAS SUBMITTED TO REPRESENT THE AUTOMATED IMPELLA CONTROLLER. THE PATIENT'S DEATH WAS REPORT ON THE AUTOMATED IMPELLA CONTROLLER REPORT. RELATED REPORT NUMBER WAS ADDED. 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

    CLINICAL NARRATIVE: AN 82-YEAR-OLD MALE WITH A MEDICAL HISTORY SIGNIFICANT FOR CORONARY ARTERY BYPASS GRAFT SURGERY AND DIABETES MELLITUS UNDERWENT IMPLANTATION OF AN IMPELLA CP DEVICE FOR TEMPORARY MECHANICAL CIRCULATORY SUPPORT. THE INDICATION FOR USE WAS CARDIOGENIC SHOCK SECONDARY TO AN ACUTE MYOCARDIAL INFARCTION. THE IMPELLA CP DEVICE WAS PERCUTANEOUSLY IMPLANTED VIA THE LEFT FEMORAL ARTERY AS A BAILOUT STRATEGY DURING CORONARY INTERVENTION. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION TO THE CIRCUMFLEX ARTERY, (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, STENT PLACEMENT, AND INTRAVASCULAR ULTRASOUND). PRIOR TO INITIATION OF IMPELLA CP SUPPORT, THE PATIENT REQUIRED MULTIPLE INOTROPIC AND VASOPRESSOR THERAPIES (GREATER THAN THREE AGENTS) AS WELL AS RESPIRATORY SUPPORT. THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) SHOCK CLASSIFICATION AT THE TIME OF IMPELLA CP INITIATION WAS STAGE E. FOLLOWING IMPELLA INSERTION, THE PLACEMENT SIGNAL AND LEFT VENTRICULAR (LV) SIGNAL WERE OBSERVED TO BE ELEVATED BEYOND THE CALIBRATED DISPLAY RANGE ON THE AUTOMATED IMPELLA CONTROLLER (AIC) CONSOLE. DEVICE ADJUSTMENT WAS PERFORMED, AFTER WHICH THE SIGNALS RETURNED TO AN ACCEPTABLE RANGE, AND NO FURTHER SIGNAL ABNORMALITIES WERE REPORTED. NO ALARMS WERE NOTED ON THE CONSOLE, AND NO DISRUPTION TO PATIENT CARE OCCURRED. THE PATIENT CONTINUED TO EXPERIENCE PROGRESSIVE HYPOTENSION WITH BLOOD PRESSURE DECREASING TO 40/30 MMHG DESPITE ADMINISTRATION OF INTRAVENOUS PUSH EPINEPHRINE EVERY FIVE MINUTES. ECHOCARDIOGRAPHY WAS PERFORMED TO REASSESS THE IMPELLA DEVICE POSITION AND CONFIRMED APPROPRIATE IMPELLA POSITIONING; HOWEVER, THE LEFT VENTRICLE DEMONSTRATED MINIMAL TO NO CONTRACTILE ACTIVITY. THE PATIENT REMAINED ON IMPELLA SUPPORT AT A PUMP PERFORMANCE LEVEL OF P-8 WITH REPORTED FLOWS OF APPROXIMATELY 3.5 L/MIN. THE FAMILY ELECTED TO DISCONTINUE FURTHER AGGRESSIVE CARE. THE PATIENT WAS DESIGNATED DO NOT RESUSCITATE AND SUBSEQUENTLY EXPIRED WHILE ON IMPELLA CP SUPPORT. THE DEVICE-RELATED COMPLAINT INVOLVING THE AUTOMATED IMPELLA CONTROLLER (AIC) IS CONSERVATIVELY REPORTED AS DEATH. THE TRANSIENT ABNORMAL DISPLAY RESOLVED FOLLOWING ADJUSTMENT WITH NO RECURRENCE, NO INTERRUPTION OF HEMODYNAMIC SUPPORT, AND NO DEVICE EXCHANGE PERFORMED. IN THIS CASE, BASED ON THE AVAILABLE INFORMATION, THE PATIENT¿S DEMISE IS PRIMARILY ATTRIBUTABLE TO THE PATIENT'S UNDERLYING CONDITION, INCLUDING ONGOING HEMODYNAMIC DETERIORATION IN THE SETTING OF PROFOUND CARDIOGENIC SHOCK (SCAI STAGE E), PERSISTENT HYPOTENSION, AND THE REQUIREMENT FOR MULTIPLE INOTROPIC AND VASOPRESSOR THERAPIES (GREATER THAN THREE AGENTS) PRIOR TO AND DURING IMPELLA SUPPORT. WITH RESPECT TO THE IMPELLA CP PUMP, NO EVIDENCE OF DEVICE MALFUNCTION OR INADEQUATE PUMP PERFORMANCE WAS IDENTIFIED. DEVICE POSITION WAS CONFIRMED TO BE APPROPRIATE BY ECHOCARDIOGRAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207582 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026775597 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1