BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24885887 · Received April 15, 2026

    Report

    Report Number
    1220648-2026-06831
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    April 10, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP IS NOT AVAILABLE FOR RETURN. 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 D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4 (SERIAL, PRIMARY UDI NUMBER). UPON REVIEW, THE SECTION D PRIMARY UDI AND SERIAL NUMBER HAVE NOW BEEN UPDATED. 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 HEMOLYSIS ISSUE COULD NOT BE DETERMINED WITHOUT RETURNED PRODUCT INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOGS.

    Additional Manufacturer Narrative · 0

    D6B: ADDED EXPLANT DATE.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 48-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI STAGE E SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WAS MILD HEMOLYSIS AS EVIDENCED BY PINK URINE AND AN ELEVATED LACTATE DEHYDROGENASE (LDH). DISCUSSION ABOUT DECREASING THE P-LEVEL DEPENDING ON PATIENT HEMODYNAMICS. THE POST-PROCEDURE OUTCOME IS UNKNOWN. THE IMPELLA FUNCTIONED AT P-7 AT 4.4L/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
    953236 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027827103 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Other