BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24222811 · Received January 30, 2026

    Report

    Report Number
    1220648-2026-01960
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    October 25, 2025
    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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H4 ADDED DEVICE MANUFACTURE DATE AS IT WAS OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED. H6 REVISED MEDICAL DEVICE PROBLEM CODE AS IT WAS REPORTED INCORRECTLY ON THE INITIAL REPORT THAT WAS SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D1 (BRAND NAME) AND D4 (SERIAL). H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE CAUSE OF THE ISCHEMIA WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE DIFFICULT TO PLACE OR POSITION WAS DETERMINED TO BE PATIENT CONDITION AS THE PATIENT HAD SMALL AXILLARY ARTERY ALONG WITH HYPERDYNAMIC SMALL LV PREVENTING THE PUMP FROM MAINTAINING OPTIMAL POSITION.

    Description of Event or Problem · 0

    A EIGHTY-ONE-YEAR-OLD FEMALE WITH A MEDICAL HISTORY INCLUDING LUPUS AND RHEUMATOID ARTHRITIS PRESENTED WITH CHEST PAIN AND SHORTNESS OF BREATH. THE PATIENT WAS INITIALLY PLACED ON BILEVEL POSITIVE AIRWAY PRESSURE AND WAS LATER INTUBATED THAT EVENING. A TRANSTHORACIC ECHOCARDIOGRAM DEMONSTRATED A FLAIL ANTERIOR LEAFLET OF THE MITRAL VALVE WITH A LEFT VENTRICULAR EJECTION FRACTION OF 60%. THE PATIENT WAS TAKEN TO THE CARDIAC CATHETERIZATION LABORATORY, WHERE A LEFT HEART CATHETERIZATION SHOWED CORONARY ARTERIES WITHIN NORMAL LIMITS. AN INTRA-AORTIC BALLOON PUMP WAS PLACED IN AN EFFORT TO STABILIZE THE PATIENT FOR SURGICAL INTERVENTION. THROUGHOUT THE DAY, THE PATIENT REQUIRED INCREASING VASOACTIVE SUPPORT, AND THE DECISION WAS MADE TO PLACE AN IMPELLA 5.5 DEVICE TO ALLOW STABILIZATION PRIOR TO SURGERY. THE PATIENT WAS TAKEN TO THE HYBRID OPERATING ROOM, AND THE LEFT AXILLARY ARTERY WAS EXPOSED. A TEN-MILLIMETER GRAFT WAS ANASTOMOSED, AND A WIRE WAS ADVANCED INTO THE LEFT VENTRICLE. THE IMPELLA 5.5 DEVICE WAS INSERTED BUT WAS UNABLE TO MAKE THE TURN FROM THE AXILLARY ARTERY INTO THE AORTA DESPITE MULTIPLE ATTEMPTS WITH VARIOUS WIRES AND MANIPULATION THROUGH THE SURGICAL INCISION. AN ANGIOGRAM PERFORMED WITH CONTRAST DEMONSTRATED THAT THE AXILLARY ARTERY WAS SMALL IN DIAMETER. THE DECISION WAS MADE TO ABORT PLACEMENT OF THE IMPELLA 5.5 AND PROCEED WITH PLACEMENT OF AN IMPELLA CP DEVICE THROUGH THE AXILLARY APPROACH. FOLLOWING THE PROCEDURE, THE PATIENT HAD LOW HEMOGLOBIN LEVELS ATTRIBUTED TO OR BLOOD LOSS AND RECEIVED MULTIPLE UNITS OF BLOOD. AFTER TRANSFER TO THE INTENSIVE CARE UNIT, THE PATIENT DEVELOPED MOTTLING OF THE LEFT ARM. OVERNIGHT, PULSES WERE LOST AND THE ARM BECAME DISCOLORED AND COOL TO THE TOUCH. THE PATIENT¿S LACTATE LEVELS INCREASED, MOST LIKELY DUE TO ISCHEMIA OF THE LEFT ARM. A DECISION WAS MADE TO REMOVE THE PUMP AND CONSIDER PLACEMENT ON THE RIGHT SIDE. PATIENT SUFFERED A MAJOR BLEED REQUIRING TRANSFUSION AND ARM ISCHEMIA REQUIRING MEDICAL DEVICE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469143 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026763630 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1