BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 371 14F LT CMR SET

    MDR report key: 24283212 · Received February 6, 2026

    Report

    Report Number
    1220648-2026-02485
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 6, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. THE EVENT WAS DETERMINED TO BE RELATED TO CHALLENGING PATIENT ANATOMY¿SPECIFICALLY SEVERE CALCIFICATION OF THE AORTA¿WHICH PREVENTED ADEQUATE DEVICE POSITIONING. NO DEVICE MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. THE PATIENT SURVIVED EXPLANT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO DOCUMENT THE FINAL INVESTIGATION CONCLUSIONS AND TO CORRECT A PREVIOUSLY REPORTED H6 MEDICAL DEVICE PROBLEM CODE. THE PROBLEM CODE A150202 (MALPOSITION OF DEVICE) REPORTED ON THE INITIAL MDR WAS NOT APPLICABLE TO THE EVENT AND HAS BEEN CORRECTED TO A050201 (POSITIONING FAILURE). H6 COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT INVESTIGATION CLOSURE. INVESTIGATION SUMMARY: HEMODYNAMIC INSTABILITY: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. UNABLE TO PLACE OR POSITION: THE CAUSE OF THE UNABLE TO PLACE OR POSITION IS MOST LIKELY PATIENT CONDITION RELATED TO SEVERE CALCIFICATION PER CLINICAL DETAILS.

    Description of Event or Problem · 0

    A (B)(6) FEMALE WITH UNKNOWN COMORBIDITIES AND A PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE D UNDERWENT IMPELLA CP INSERTION FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. ALTHOUGH THE DEVICE WAS INITIALLY ADVANCED, THE CLINICAL TEAM WAS UNABLE TO REPOSITION IT BACK INTO PROPER POSITION DESPITE MULTIPLE ATTEMPTS. THE CP WAS REMOVED AND INTRA AORTIC BALLOON PUMP (IABP) WAS PLACED. THE EVENT WAS DETERMINED TO BE RELATED TO CHALLENGING PATIENT ANATOMY¿SPECIFICALLY SEVERE CALCIFICATION OF THE AORTA¿WHICH PREVENTED ADEQUATE DEVICE POSITIONING. NO DEVICE MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. THE PATIENT SURVIVED EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46865 PUMP 371 14F LT CMR SET TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. PUMP 371 14F LT CMR SET 2026685915 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention