BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CPSA C9+ SET, OUS

    MDR report key: 24631595 · Received March 18, 2026

    Report

    Report Number
    1220648-2026-05490
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    February 24, 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

    A4 WEIGHT IS UNKNOWN. 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

    ACCESS SITE ADVERSE EVENT/ MAJOR BLEED: THE CAUSE OF THE BLEEDING ISSUE WAS MOST LIKELY USE RELATED DUE PATIENT MOVEMENT SINCE THE PATIENT WAS NON-COMPLIANT IN BED AND MOBILIZED THE LEG ON THE IMPELLA INSERTION SIDE AND LED TO ACCESS-SITE BLEEDING.

    Additional Manufacturer Narrative · 0

    D4 CATALOG NUMBER AND D4 SERIAL NUMBER WERE UPDATED, CORRECTED ACCORDINGLY.

    Description of Event or Problem · 0

    CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA LEFT FEMORAL ARTERY IN A 68 YEAR OLD MALE FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. ON DAY 3 OF SUPPORT, WHILE IN THE INTENSIVE CARE UNIT, THE PATIENT WAS NON-COMPLIANT IN BED AND MOBILIZED THE LEG ON THE IMPELLA INSERTION SITE, WHICH LED TO BLEEDING AT THE ACCESS SITE. DUE TO THE NEED FOR CONTINUED HEMODYNAMIC SUPPORT, THE DECISION WAS MADE TO ESCALATE FROM IMPELLA CP TO IMPELLA 5.5. BRIDGE TO 5.5 WAS SUCCESSFULLY PERFORMED AND AN IMPELLA 5.5. INSERTED VIA LEFT AXILLARY ARTERY. THE PATIENT RECEIVED 2 UNITS OF PACKED RED BLOOD CELLS. THE FEMORAL ACCESS SITE WAS CLOSED USING A MANTA CLOSURE DEVICE. BLEEDING IS A KNOWN RISK ASSOCIATED WITH IMPELLA CP AS DESCRIBED IN THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28869 IMPELLA CPSA C9+ SET, OUS TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026760259 00813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1