BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25230916 · Received May 20, 2026

    Report

    Report Number
    1220648-2026-08031
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    May 14, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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: IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 78 YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK STAGE E. DURING INSERTION OF THE CATHETER, THE PHYSICIAN NOTED THAT THE CATHETER WAS KINKED. A DECISION WAS MADE TO EXCHANGE THE CATHETER FOR A NEW DEVICE. EXCESSIVE FORCE DURING PLACEMENT WAS IDENTIFIED AS A CONTRIBUTING FACTOR. THE DEVICE WAS EXCHANGED, AND NO FURTHER ISSUES WERE REPORTED FOLLOWING REPLACEMENT. NO PATIENT HARM WAS NOTED. THE PATIENT SURVIVED TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228742 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027872154 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention