BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 371 14F LT CMR SET

    MDR report key: 24326797 · Received February 12, 2026

    Report

    Report Number
    1220648-2026-03063
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    December 21, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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.

    Description of Event or Problem · 0

    A 67-YEAR-OLD MALE PATIENT WAS ADMITTED VENTILATED TO THE HOSPITAL WITH ACUTE MYOCARDIAL INFARCTION CARDIOGENIC SHOCK (AMICS) WITH A MEAN ATRIAL PRESSURE OF 120 MMHG (UNDER 1 CATECHOLAMINE AND RESPIRATORY SUPPORT) WITH AN ARTERIAL LACTATE OF 12.0 MMOL/L IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK STAGE E. HE HAD A KNOWN HISTORY OF DIABETES MELLITUS. IMPELLA CP WAS PLACED INSERTED FOR HEMODYNAMIC STABILIZATION WITH ULTRASOUND-GUIDED MICRO-PUNCTURE VIA THE RIGHT FEMORAL ARTERY AND THE SUPPLIED 14 FRENCH X 25 CM PEEL-AWAY SHEATH WITHOUT A PERCUTANEOUS CORONARY INTERVENTION PERFORMED AND TRANSFERRED TO THE INTENSIVE CARE UNIT. WHEN ARRIVED THE INTENSIVE CARE UNIT FOR CHECK-IN, THE COMPLAINT APPEARED AS NO PULSES IN BOTH FEET WERE DETECTED BY DOPPLER ECHO. BESIDES, THE SURGICAL TEAM DECIDED TO TAKE THE PATIENT TO THE OPERATING ROOM TO REPAIR HIS VENTRICULAR SEPTUM DEFECT (VSD), WHICH WAS APPARENTLY THE REASON FOR THE AMICS. ADDITIONALLY, A VASCULAR SURGEON WAS CONSULTED TO ASSESS VASCULATURE IN BILATERAL EXTREMITIES. SUBSEQUENTLY, DECISION WAS MADE TO REMOVE IMPELLA CP WITH A VASCULAR SURGERY TO ATTEMPT TO REVASCULARIZE THE PATIENT POST-VSD REPAIR, SO, IMPELLA WAS IN PLACE DURING THE VSD REPAIR FOR LEFT VENTRICULAR UNLOADING OF THE FAILING HEART BUT REMOVED BEFORE THE REVASCULARIZATION. IMPELLA CP WAS REMOVED WITHOUT DIFFICULTIES BY SURGICAL CUTDOWN TECHNIQUE WITH PRIMARY CLOSER WITH VASCULAR SURGERY. NO COMPLICATIONS WITH REMOVAL OR CLOSURE AND NO BLEEDING POST-REMOVAL OCCURRED AND THE PATIENT SURVIVED. IT WAS DOCUMENTED THAT THE LIMB VESSELS WERE CALCIFIED (ALSO DIABETES MELLITUS MAY HAVE CONTRIBUTERD TO THAT FACT) AND PER INSTRUCTIONS FOR USE, CALCIFIED VESSELS MAY PRECLUDE THE INSERTION OF IMPELLA CP - IT IS TO CAREFULLY WEIGH THE RISKS AND BENEFITS. THE IMPELLA CP IS CODED FOR ISCHEMIA, WHICH IS PROBABLY RELATED TO THE IMPELLA CP INSERTION AND THE UNDERLYING DISEASE OF CARDIOGENIC SHOCK WITH VASOCONSTRICTED VESSELS AND THE PERIPHERAL ARTERY DISEASE, DOCUMENTED AS CALCIFIED VESSELS. MOREOVER, IMPELLA CP WAS CODED FOR THE MEDICAL DEVICE REMOVAL, WHICH ALLOVER CAUSED A SERIOUS INJURY, WHICH EVENTUALLY COULD BE OVERCOME WITH A SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383774 PUMP 371 14F LT CMR SET TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 371 14F LT CMR SET 2026787382 813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention