BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24876736 · Received April 14, 2026

    Report

    Report Number
    1220648-2026-06780
    Event Type
    Death
    Date Received
    April 14, 2026
    Date of Event
    April 8, 2026
    Report Date
    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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN 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.

    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. CORRECTED INFORMATION WAS PROVIDED IN B1 AND E4. UPON REVIEW, IT WAS IDENTIFIED THAT THESE WERE INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4. UPON REVIEW, THE PRIMARY UDI NUMBER HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D4. MAJOR BLEED: THE CAUSE OF MAJOR BLEED WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW. LOW OR BLOCKED PUMP FLOW: THE CAUSE OF LOW OR BLOCKED PUMP FLOW WAS MOST LIKELY PATIENT CONDITION RELATED SINCE THE CLINICAL TEAM CONFIRMED THE ISSUE WAS DUE TO LACK OF PRELOAD AND HEMORRHAGIC SHOCK.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CPSA C9 DEVICE WAS INSERTED INTO THE LEFT FEMORAL ARTERY IN A 83-YEAR-OLD FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI STAGE C SHOCK, AND ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WAS A SUCTION ALARM DUE TO LACK OF VOLUME AND HEMORRHAGIC SHOCK. THERE WAS ALSO BLEEDING FROM THE NON-IMPELLA GROIN FROM THE CARDIAC CATHETERIZATION. AFTER 11 HOURS ON SUPPORT, THE FAMILY WITHDREW CARE AND THE PATIENT EXPIRED ON SUPPORT. THE IMPELLA FUNCTIONED AT P-6 AT 2.5L/MIN AS INTENDED. THE IMPELLA CP WAS REMOVED ON SITE AND DISCARDED, AS THE DOCTOR STATED THAT THE PUMP WAS NOT THE CAUSE OF THE PROBLEM. 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 CLINICAL CONDITION OF A CRITICALLY ILL PATIENT IN ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, COMPLICATED BY STAGE C SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261790 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMPP OZD ABIOMED, INC. - 1220648 2026757342 00813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1