BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25299568 · Received May 27, 2026

    Report

    Report Number
    1220648-2026-08179
    Event Type
    Death
    Date Received
    May 27, 2026
    Date of Event
    May 16, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CODING WAS CORRECTED AND AS A RESULT H6 HEALTH EFFECT - CLINICAL/IMPACT AND MEDICAL DEVICE PROBLEM CODING WAS UPDATED, CORRECTED ACCORDINGLY. ADDITIONALLY, THE CLINICAL NARRATIVE WAS UPDATED AND CAPTURED TO B5 EVENT DESCRIPTION. NOTE: TYPE OF REPORTABLE EVENT REMAINS UNCHANGED. B7 MEDICAL HISTORY/PREEXISTING CONDITION FIELD WAS UPDATED ACCORDINGLY.

    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

    UPDATED CLINICAL NARRATIVE: ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE INDICATING THAT TWO INTERVENTIONAL CARDIOLOGISTS ATTEMPTED TO TREAT A LARGE, CALCIFIED RIGHT CORONARY ARTERY LESION WITHOUT SUCCESS. THE PATIENT WAS NOT CONSIDERED A SURGICAL CANDIDATE, AND BASED ON THE OVERALL CLINICAL CONDITION AND LACK OF REVASCULARIZATION OPTIONS, THE FAMILY ELECTED TO WITHDRAW CARE. THE FIELD REPRESENTATIVE REPORTED THAT THE IMPELLA DEVICE WAS NOT CONSIDERED A CONTRIBUTING FACTOR IN THE PATIENT¿S DEATH. PREVIOUS CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY IN A 49-YEAR-OLD MALE PATIENT FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT HAD A KNOWN HISTORY OF CORONARY ARTERY DISEASE (CAD) AND THE CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS CONSISTENT WITH SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE C CARDIOGENIC SHOCK. IMAGING ASSESSMENT WAS LIMITED DUE TO POOR ECHOCARDIOGRAPHIC WINDOWS. DURING THE COURSE OF CARE, THE PATIENT WAS TRANSFERRED FROM THE CARDIAC CATHETERIZATION TABLE TO AN INTENSIVE CARE UNIT BED. AN ECHOCARDIOGRAM WAS PERFORMED TO CONFIRM DEVICE POSITIONING; HOWEVER, DURING REPOSITIONING, THE IMPELLA CP WAS INADVERTENTLY PULLED BACK ACROSS THE AORTIC VALVE, REPRESENTING A DEVICE DISPLACEMENT EVENT. DEVICE SUPPORT AT THE TIME WAS REPORTED AT APPROXIMATELY PERFORMANCE LEVEL P-5 WITH FLOWS OF 2.4 L/MIN. DUE TO THE PATIENT¿S CLINICAL DETERIORATION, A SECOND IMPELLA CP DEVICE WAS PLACED AND SUPPORT WAS CONTINUED. DESPITE THESE INTERVENTIONS, THE PATIENT¿S CONDITION PROGRESSED, AND A DECISION WAS MADE TO WITHDRAW CARE. THE PATIENT SUBSEQUENTLY EXPIRED WHILE SUPPORTED ON THE SECOND IMPELLA CP DEVICE. THE PATIENT¿S OUTCOME IS MOST CONSISTENT WITH THE SEVERITY OF THE UNDERLYING ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, IN THE SETTING OF KNOWN CORONARY ARTERY DISEASE, HEMODYNAMIC INSTABILITY, AND LIMITED IMAGING CAPABILITY FOR OPTIMAL DEVICE MANAGEMENT DUE TO POOR ECHOCARDIOGRAPHIC WINDOWS. THESE FACTORS REFLECT A CRITICALLY ILL CLINICAL PRESENTATION WITH REDUCED MYOCARDIAL FUNCTION, IMPAIRED CARDIAC OUTPUT, AND ONGOING CARDIOGENIC COMPROMISE DESPITE MECHANICAL CIRCULATORY SUPPORT. THE DEATH IS CONSERVATIVELY BEING REPORTED ON THE FIRST IMPELLA CP DEVICE, GIVEN THE TEMPORAL ASSOCIATION WITH THE DISPLACEMENT EVENT REQUIRING DEVICE REPLACEMENT. NO ADVERSE EVENTS ARE CODED TO THE SECOND IMPELLA CP DEVICE, AS THERE WERE NO ADDITIONAL REPORTED DEVICE-RELATED PERFORMANCE CONCERNS FOLLOWING REINSERTION.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY IN A 49-YEAR-OLD MALE PATIENT FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT HAD A KNOWN HISTORY OF CORONARY ARTERY DISEASE (CAD) AND THE CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS CONSISTENT WITH SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE C CARDIOGENIC SHOCK. IMAGING ASSESSMENT WAS LIMITED DUE TO POOR ECHOCARDIOGRAPHIC WINDOWS. DURING THE COURSE OF CARE, THE PATIENT WAS TRANSFERRED FROM THE CARDIAC CATHETERIZATION TABLE TO AN INTENSIVE CARE UNIT BED. AN ECHOCARDIOGRAM WAS PERFORMED TO CONFIRM DEVICE POSITIONING; HOWEVER, DURING REPOSITIONING, THE IMPELLA CP WAS INADVERTENTLY PULLED BACK ACROSS THE AORTIC VALVE, REPRESENTING A DEVICE DISPLACEMENT EVENT. DEVICE SUPPORT AT THE TIME WAS REPORTED AT APPROXIMATELY PERFORMANCE LEVEL P-5 WITH FLOWS OF 2.4 L/MIN. DUE TO THE PATIENT¿S CLINICAL DETERIORATION, A SECOND IMPELLA CP DEVICE WAS PLACED AND SUPPORT WAS CONTINUED. DESPITE THESE INTERVENTIONS, THE PATIENT¿S CONDITION PROGRESSED, AND A DECISION WAS MADE TO WITHDRAW CARE. THE PATIENT SUBSEQUENTLY EXPIRED WHILE SUPPORTED ON THE SECOND IMPELLA CP DEVICE. THE PATIENT¿S OUTCOME IS MOST CONSISTENT WITH THE SEVERITY OF THE UNDERLYING ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, IN THE SETTING OF KNOWN CORONARY ARTERY DISEASE, HEMODYNAMIC INSTABILITY, AND LIMITED IMAGING CAPABILITY FOR OPTIMAL DEVICE MANAGEMENT DUE TO POOR ECHOCARDIOGRAPHIC WINDOWS. THESE FACTORS REFLECT A CRITICALLY ILL CLINICAL PRESENTATION WITH REDUCED MYOCARDIAL FUNCTION, IMPAIRED CARDIAC OUTPUT, AND ONGOING CARDIOGENIC COMPROMISE DESPITE MECHANICAL CIRCULATORY SUPPORT. THE DEATH IS CONSERVATIVELY BEING REPORTED ON THE FIRST IMPELLA CP DEVICE, GIVEN THE TEMPORAL ASSOCIATION WITH THE DISPLACEMENT EVENT REQUIRING DEVICE REPLACEMENT. NO ADVERSE EVENTS ARE CODED TO THE SECOND IMPELLA CP DEVICE, AS THERE WERE NO ADDITIONAL REPORTED DEVICE-RELATED PERFORMANCE CONCERNS FOLLOWING REINSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324773 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027868747 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1