BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24604188 · Received March 16, 2026

    Report

    Report Number
    1220648-2026-05306
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    March 9, 2026
    Report Date
    March 19, 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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6B UPDATED. THE INVESTIGATION IS STILL ONGOING.

    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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. CORRECTED INFORMATION HAS BEEN PROVIDED IN B1(S PRODUCT PROBLEM); D1; D4(SERIAL) D1: TICKED TO CAPTURE PRODUCT MALFUNCTION. THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED AS NO PRODUCT OR LOGS WERE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY FOR THE SUPPORT OF A 52 YEAR OLD FEMALE PATIENT WHO HAD BEEN ADMITTED INTO THE MEDICAL CENTER WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE C SHOCK. THE PATIENT WAS ON INOTROPES/VASOPRESSORS AND A VENT FOR RESPIRATORY NEEDS PRIOR TO THE PUMP INSERTION. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PUMP WAS SUPPORTING WHEN ON THE 2ND DAY OF THE SUPPORT THERE WAS CONCERNS OF HEMOLYSIS. THE TEAM OBSERVED TINGED URINE AND SO THE TEAM REDUCED THE P LEVEL AND CHECKED THE POSITION OF THE PUMP ON ECHO IMAGING. THE PUMP REMAINS ON FOR SUPPORT DESPITE THE HEMOLYSIS CONCERNS AND URINE COLOR IS IMPROVING WITH THE TROUBLESHOOTING. HEMOLYSIS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, RENAL FUNCTION, ANTICOAGULATION STATUS, AND POTENTIAL DEVICE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605911 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026734125 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1