BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24715621 · Received March 30, 2026

    Report

    Report Number
    1220648-2026-06048
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 20, 2026
    Report Date
    April 15, 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
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: CLINICAL CODE E0303 CHANGED TO E1302.

    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.

    Additional Manufacturer Narrative · 0

    UPON REVIEW, IT WAS IDENTIFIED THAT THE MANUFACTURER FAX (D3) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE FAX NUMBER HAS NOW BEEN PROVIDED. CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 SERIAL NUMBER. CORRECTED INFORMATION HAS BEEN PROVIDED IN WAS THIS DEVICE SERVICED BY 3RD PARTY (D8) FROM UNKNOWN TO NO. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF CARDIAC ARREST CAN NOT BE DETERMINED AS INSUFFICIENT CLINICAL DETAILS WERE PROVIDED. THE CAUSE OF HEMATURIA CAN NOT BE DETERMINED AS INSUFFICIENT CLINICAL DETAILS WERE PROVIDED. THE CAUSE OF LOW OR BLOCKED PUMP FLOW WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE PUMP IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 62-YEAR-OLD MALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN AN OUT-OF-HOSPITAL CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR), ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WAS HEMOLYSIS IN THE URINE. THE PATIENT RECEIVED INTEGRILLIN, ANGIOMAX, AND HEPARIN FOR THE PCI. THERE WAS POSSIBLE TRAUMATIC FOLEY INSERTION. THE PATIENT ALSO HAD SUCTION EVENTS WHILE THE PATIENT WAS BEING CODED IN THE CATH LAB REQUIRING CPR. THREE DAYS AFTER IMPELLA INSERTION, THE DEVICE WAS SUCCESSFULLY WEANED. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-4 AT 2.4L/MIN AS INTENDED. HEMOLYSIS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, AND POTENTIAL DEVICE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607076 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027837903 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1