BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24816951 · Received April 8, 2026

    Report

    Report Number
    1220648-2026-06516
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    March 29, 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
    GA, 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.

    Description of Event or Problem · 0

    THE PATIENT A 65-YEAR-OLD FEMALE HAD AN INDICATION FOR USE OF TEMPORARY MECHANICAL CIRCULATORY SUPPORT DUE TO ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK, WITH A PRE SUPPORT CLINICAL CONDITION CONSISTENT WITH SCAI SHOCK STAGE E. AN IMPELLA CP WAS PLACED PERCUTANEOUSLY VIA THE RIGHT FEMORAL ARTERY. DURING SUPPORT, THE BEDSIDE NURSE REPORTED INTERMITTENT LOW PLACEMENT SIGNAL ALARMS ON THE AUTOMATED IMPELLA CONTROLLER (AIC). THE PHYSICIAN REPOSITIONED THE DEVICE, WHICH TEMPORARILY RESOLVED THE ALARMS. SUBSEQUENTLY, THE AIC AGAIN ALARMED INTERMITTENTLY FOR ¿PLACEMENT SIGNAL LOW,¿ ¿IMPELLA IN THE AORTA,¿ AND ¿IMPELLA IN THE VENTRICLE.¿ TRANSTHORACIC ECHOCARDIOGRAPHY CONFIRMED THAT THE IMPELLA WAS ACROSS THE AORTIC VALVE; HOWEVER, IMAGING QUALITY WAS SUBOPTIMAL FOR PRECISE MEASUREMENTS. THE PHYSICIANS WERE PRESENT AT THE BEDSIDE AND MANIPULATED THE DEVICE UNTIL ALARMS RESOLVED AND ELECTED TO LEAVE THE DEVICE IN THAT POSITION. LATER, THE PATIENT WAS NOTED TO HAVE LOSS OF PULSE AND DEVELOPMENT OF A PALE, COOL LIMB, CONSISTENT WITH LIMB ISCHEMIA, WHICH WAS DIAGNOSED BY LOSS OF DISTAL PULSES. THE DEVICE WAS SUBSEQUENTLY REMOVED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED LIMB ISCHEMIA OCCURRED IN TEMPORAL ASSOCIATION WITH IMPELLA CP SUPPORT AND DEVICE REPOSITIONING. THE EVENT REQUIRED DEVICE REMOVAL AND WAS CONSIDERED A PATIENT INJURY ATTRIBUTED TO IMPELLA SUPPORT; HOWEVER, A DEFINITIVE DEVICE MALFUNCTION COULD NOT BE CONFIRMED. CONTRIBUTING PATIENT SPECIFIC FACTORS, INCLUDING CARDIOGENIC SHOCK, PERIPHERAL VASCULAR DISEASE, FEMORAL ARTERIAL ACCESS, AND CRITICAL ILLNESS, MAY HAVE PLAYED A ROLE. THE DEVICE WILL NOT BE RETURNED. DEVICE INVOLVEMENT CANNOT BE FULLY ASSESSED WITHOUT PRODUCT EVALUATION AND DEVICE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37284 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027853080 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention