BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25276694 · Received May 26, 2026

    Report

    Report Number
    1220648-2026-08148
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    May 18, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013368
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. SECTION A WAS LEFT BLANK. 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

    AN IMPELLA CP WAS INSERTED TO SUPPORT A PATIENT WHO HAD BEEN ADMITTED IN WITH A ST-ELEVATION MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK PRESENTING IN SCAI STAGE E SHOCK. THE ACCESS SITE, AGE, AND GENDER WERE NOT SHARED BY THE TEAM IN SOUTH KOREA, NOR WERE ANY MEDICAL HISTORY AND COMORBIDITIES. THE TEAM UTILIZED THE CP FOR SUPPORT AND PERFORMED A PERCUTANEOUS CORONARY INTERVENTION. THE TEAM THEN OBSERVED SIGNS OF LIMB ISCHEMIA AS THE DISTAL PERFUSION WAS SEVERELY COMPROMISED AND THE EJECTION FRACTION WAS 10%. THE DECISION WAS MADE TO ADD EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO) TO FURTHER SUPPORT THE PATIENT. DURING THE CANNULATION OF THE ECMO THE PATIENT HAD CPR TO MAINTAIN CARDIAC AND END-ORGAN PERFUSION. WHEN THE ECMO SUPPORT INITIATION WAS COMPLETED THE CP WAS EXPLANTED. THE PATIENT REMAINED ON ECMO SUPPORT, AND NO FURTHER PATIENT OUTCOME DETAILS WERE PROVIDED. AS NO PATIENT HISTORY WAS SHARED, THERE IS NO INFORMATION ON ANY COMORBIDITIES THAT CAN CONTRIBUTE TO THE LIMB ISCHEMIA. LIMB ISCHEMIA IS A KNOWN RISK WITH LARGE BORE ACCESS SHEATHS AND HAS AN INCREASED RISK OF OCCURRENCE IN PATIENTS IN SCAI SHOCK STAGE C,D, AND E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506958 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026802478 00813502013368

    Patients

    Seq Age Sex Outcome Treatment
    1