BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25232952 · Received May 20, 2026

    Report

    Report Number
    1220648-2026-08039
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    May 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011371
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 73-YEAR-OLD MALE PATIENT FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE NOT REPORTED. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E CARDIOGENIC SHOCK. THE IMPELLA CP DEVICE WAS PLACED PRIOR TO PERCUTANEOUS CORONARY INTERVENTION. FOLLOWING COMPLETION OF THE PROCEDURE, THE 14 FRENCH PEEL-AWAY INTRODUCER SHEATH WAS REMOVED AND REPLACED WITH A REPOSITIONING SHEATH, WHICH WAS SECURED PRIOR TO TRANSFER TO THE INTENSIVE CARE UNIT. SUBSEQUENTLY, BLEEDING WAS OBSERVED AT THE FEMORAL ACCESS SITE. THE PURGE SOLUTION CONSISTED OF DEXTROSE 5 PERCENT IN WATER WITH 6.25 UNITS PER MILLILITER OF HEPARIN. THE PATIENT RECEIVED BLOOD PRODUCT TRANSFUSION; HOWEVER, THE BLEEDING DID NOT IMPROVE. IN THE SETTING OF ONGOING ACCESS-SITE BLEEDING, A CLINICAL DECISION WAS MADE TO REMOVE THE IMPELLA CP DEVICE. THE PATIENT SURVIVED TO EXPLANT. THE REPORTED ACCESS-SITE BLEEDING IS CONSISTENT WITH KNOWN RISKS ASSOCIATED WITH LARGE-BORE FEMORAL ARTERIAL ACCESS AND THE ANTICOAGULATION AND PURGE REQUIREMENTS OF IMPELLA SUPPORT IN THE SETTING OF CARDIOGENIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34934 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026703787 00813502011371

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention