BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CPSA C9+ SET, OUS

    MDR report key: 24512780 · Received March 4, 2026

    Report

    Report Number
    1220648-2026-04475
    Event Type
    Injury
    Date Received
    March 4, 2026
    Date of Event
    February 23, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 ADDED PRIMARY UDI NUMBER AS IT WAS OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENTS THE IMPELLA CP AND ANOTHER REPORT WILL BE SUBMITTED TO REPRESENT THE IMPELLA 5.5. 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

    ISCHEMIA/THROMBOSIS/PPAE: THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA CP DEVICE WAS INSERTED INTO THE FEMORAL ARTERY IN A 55-YEAR-OLD FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT DURING A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THREE DAYS AFTER THE IMPELLA INSERTION, THE IMPELLA CP WAS REMOVED WITH AN ESCALATION OF THERAPY TO AN IMPELLA 5.5. THE IMPELLA FUNCTIONED AT P-9 AS INTENDED. AFTER THE IMPELLA CP WAS REMOVED, IT WAS NOTED THAT THERE WAS THROMBUS IN THE LEFT FEMORAL ARTERY, RESULTING IN LIMB ISCHEMIA. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A THROMBECTOMY PROCEDURE. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. LIMB ISCHEMIA MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS THE PATIENT'S SEVERE PERIPHERAL VASCULAR DISEASE, UNDERLYING CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, AND VASCULAR ACCESS CHARACTERISTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24796 IMPELLA CPSA C9+ SET, OUS TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026812188 00813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1