BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24424565 · Received February 23, 2026

    Report

    Report Number
    1220648-2026-03860
    Event Type
    Death
    Date Received
    February 23, 2026
    Date of Event
    October 24, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    D4: CORRECTED UDI. H6: OMITTED CODE E2321 AND F1903. INVESTIGATION SUMMARY: PPAE (FEVER): THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1840649. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE PUMP SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D4 CATALOG NUMBER AND SERIAL NUMBER UPDATED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D1 (BRAND NAME). H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA RP FLEX DEVICE WAS INSERTED INTO THE RIGHT FEMORAL VEIN IN A 69-YEAR-OLD MALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS) IN SCAI STAGE E SHOCK, ON MULTIPLE INOTROPES, VASOPRESSORS, VENTILATOR SUPPORT, AND IMPELLA CP DEVICE (INSERTED INTO THE RIGHT FEMORAL ARTERY) PRIOR TO INITIATION OF SUPPORT. THE IMPELLA RP FLEX DEVICE WAS INSERTED FOR ADDITIONAL VENTRICULAR SUPPORT FOLLOWING RIGHT CORONARY ARTERY (RCA) PERFORATION AND IDENTIFICATION OF VENTRICULAR SEPTAL DEFECT (VSD) DURING HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RCA. WHILE IN THE INTENSIVE CARE UNIT (ICU), AWAITING TRANSFER TO ANOTHER HOSPITAL FOR A HIGHER LEVEL OF CARE, THE PATIENT¿S HEMODYNAMICS INITIALLY IMPROVED. THE PATIENT SUBSEQUENTLY BECAME ACIDOTIC WITH A TEMPERATURE OF 105. THE PATIENT¿S CONDITION CONTINUED TO WORSEN DESPITE SUPPORT WITH IMPELLA CP, IMPELLA RP FLEX, AND MULTIPLE PRESSORS. CARE WAS WITHDRAWN AND THE POST-PROCEDURE OUTCOME WAS EXPIRED AT EXPLANT. THE DEVICE IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S FEVER OR DEATH, WHICH WAS MOST LIKELY DUE TO THE CLINICAL CONDITION OF A CRITICALLY ILL PATIENT WITH AMI COMPLICATED BY CGS AS THEY PRESENTED IN SCAI STAGE E SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512248 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 RP FLEX W SMART ASSIST SET, US 2025548235 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death| R