BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25001557 · Received April 27, 2026

    Report

    Report Number
    1220648-2026-07150
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    April 17, 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
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). 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 FOR ANALYSIS.

    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

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN AN 86-YEAR-OLD MALE PATIENT FOR HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI), WITH A HISTORY OF KNOWN CORONARY ARTERY DISEASE. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE B. THE REGISTERED NURSE NOTED A CONTINUOUS SUCTION ALARM AT P2. IMPELLA FLOW READING WAS 0.0 REGARDLESS OF ANY PERFORMANCE LEVEL. MOTOR CURRENT WAS 203/184 AND FLAT. A 250 ML LACTATED RINGER¿S BOLUS WAS GIVEN. THE PATIENT REMAINED STABLE, AND PARTIAL THROMBOPLASTIN TIME (PTT) WAS THERAPEUTIC. A STAT ECHOCARDIOGRAM WAS ADVISED. THE DEVICE WAS REMOVED AND THE PATIENT SURVIVED TO EXPLANT. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR SERIOUS INJURY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE DEVICE REMOVAL; HOWEVER, THE REMOVAL WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT AND THE PATIENT REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316360 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027837657 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1