BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24574329 · Received March 11, 2026

    Report

    Report Number
    1220648-2026-04995
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    March 2, 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
    AR, 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.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D1 (BRAND NAME). UPON REVIEW, IT WAS IDENTIFIED THAT THE SECTION D BRAND NAME HAS NOW BEEN UPDATED. CORRECTED INFORMATION WAS PROVIDED IN D3, G1 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN E1 (ZIP CODE EXTENSION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN E3 (INITIAL REPORTER OCCUPATION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY SUBMITTED IN ERROR IN THE INITIAL REPORT. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED AS NO PRODUCT OR LOGS WERE RETURNED AND INSUFFICIENT CLINICAL INFORMATION WAS PROVIDED

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS BEING SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE CONFIRMING THAT THERE IS NO DEVICE AVAILABLE FOR RETURN. THIS INFORMATION IS CONSISTENT WITH THE INITIAL MDR, WHICH REPORTED THAT THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. AS NO DEVICE IS AVAILABLE, DEVICE EVALUATION COULD NOT BE PERFORMED. NO ADDITIONAL INFORMATION IMPACTING THE PREVIOUSLY REPORTED DEVICE RETURN STATUS IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    CLINICIAN NARRATIVE AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 64-YEAR-OLD MALE WHO PRESENTED WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK WITH KNOWN CORONARY ARTERY DISEASE. AT THE TIME OF INSERTION, THE PATIENT WAS CLASSIFIED AS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS STAGE D CARDIOGENIC SHOCK AND REQUIRED INOTROPES, VASOPRESSORS, AND MECHANICAL VENTILATION FOR RESPIRATORY SUPPORT. THE PATIENT ALSO UNDERWENT LEFT ANTERIOR DESCENDING CORONARY ANGIOPLASTY, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WITH STENT PLACEMENT, AND THROMBECTOMY. FOLEY CATHETER INSERTION IN THE INTENSIVE CARE UNIT, THE PATIENT¿S URINE OUTPUT BECAME PINK TO RED. A BEDSIDE ECHOCARDIOGRAM WAS PERFORMED AND IMPELLA POSITION WAS ASSESSED, WITH THE DEVICE NOTED TO BE FREE FROM VENTRICULAR STRUCTURES AND WELL POSITIONED IN THE LEFT VENTRICLE. DURING THIS TIME, MEAN ARTERIAL PRESSURE WAS SUSTAINED IN THE 115 TO 120 RANGE FOR MULTIPLE HOURS. THE CARE TEAM INITIATED A MILRINONE INFUSION, THERAPEUTICALLY LOWERED THE MEAN ARTERIAL PRESSURE TO THE 80 RANGE, AND WEANED IMPELLA SUPPORT TO P-5 WITH 2.8 LITERS PER MINUTE OF FLOW. FOLLOWING THESE MEASURES, THE URINE BEGAN TO CLEAR. PATIENT EXPERIENCE WAS REPORTED AS HEMOLYSIS AND MEDICATION REQUIRED. A COMPREHENSIVE REVIEW OF THE AVAILABLE INFORMATION INDICATES THAT THE REPORTED HEMOLYSIS IS MOST CONSISTENT WITH THE PATIENT¿S CRITICAL UNDERLYING CONDITION, ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK, HYPERTENSION, AND THE NEED FOR COMPLEX INTERVENTIONAL AND MECHANICAL CIRCULATORY SUPPORT, WHICH ARE RECOGNIZED FACTORS ASSOCIATED WITH HEMOLYSIS IN THIS PATIENT POPULATION. THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15698 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027835889 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1