BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25306515 · Received May 27, 2026

    Report

    Report Number
    1220648-2026-08197
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    May 20, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    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

    AN IMPELLA 5.5 WAS INSERTED VIA THE DIRECT SURGICAL ACCESS TO SUPPORT THE 68 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN FOR AN OFF-PUMP CORONARY ARTERY BYPASS (OPCAB), AND HAD PRESENTED IN SCAI STAGE E AT THE PUMP INSERTION. UNDERLYING MEDICAL HISTORY WAS NOT SHARED, BEYOND THE KNOWN CORONARY ARTERY DISEASE AND DIABETES. THE PATIENT HAD SIGNS OF HEMOLYSIS ON THE DAY OF IMPLANT. THE URINE OUTPUT WAS >30 ML/HR AND WAS RED IN COLOR. THE LABS ALSO WERE SEEN TO HAVE RISEN FROM 214 TO 271 IU/L. THE TEAM TROUBLESHOT BY REDUCTION IN THE PUMP P-LEVEL. AT P-LEVEL OF 5 THE THE FLOWS ARE 3.1 L/MIN. THE ECHO IMAGING WAS PERFORMED, BUT AS POSTOPERATIVE THE IMAGING WAS NOT THE MOST DIAGNOSTIC VIEW. THE CONCERNS FOR HEMOLYSIS PERSIST AND THE P-LEVEL IS BEING KEPT LOWER PER PHYSICIAN REQUEST DUE TO THE SUSPICION OF HEMOLYSIS. NO FURTHER INTERVENTION HAS BEEN SHARED TO DATE. HEMOLYSIS MAY OCCUR IN THE SETTING OF PURGE-RELATED ANTICOAGULATION REQUIREMENTS, THE PATIENT IS ADDITIONALLY ON PLAVIX, AND MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551844 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027868899 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1