BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24208648 · Received January 29, 2026

    Report

    Report Number
    1220648-2026-01824
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    January 19, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO DOCUMENT THE FINAL INVESTIGATION CONCLUSIONS. H6 COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT INVESTIGATION CLOSURE. INVESTIGATION SUMMARY ==> ISCHEMIA: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. MAJOR BLEED/ACCESS SITE ADVERSE EVENT: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS

    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 63 YEAR OLD FEMALE WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK UNDERWENT PLACEMENT OF AN IMPELLA CP (SERIAL (B)(6), (B)(4); GU CASE (B)(4)) VIA RIGHT FEMORAL ARTERIAL, PERCUTANEOUS ACCESS. THE DEVICE WAS IMPLANTED ON (B)(6) 2026 AT 18:39. DURING THE COURSE OF SUPPORT, THE PATIENT DEVELOPED LIMB ISCHEMIA AND MAJOR ACCESS SITE BLEEDING. ACCORDING TO THE CLINICAL TEAM, THE PATIENT WAS ON FOUR PRESSORS/INOTROPES AND HAD KNOWN PAD/PVD AND OBESITY. PULSES IN THE AFFECTED LIMB WERE LOST FOLLOWING REPOSITIONING UNIT INSERTION, WITH ASSOCIATED COLOR CHANGE NOTED THE MORNING OF (B)(6) 2026. BASED ON THE INFORMATION PROVIDED, THE PATIENT EXPERIENCED MAJOR ACCESS SITE BLEEDING AND RIGHT LOWER EXTREMITY ISCHEMIA DURING IMPELLA CP SUPPORT. THESE EVENTS OCCURRED IN THE CONTEXT OF MULTIPLE CONTRIBUTING FACTORS, INCLUDING PAD/PVD, HIGH VASOPRESSOR REQUIREMENTS, AND ANTITHROMBOTIC THERAPY. THE CLINICAL TEAM ATTRIBUTED BOTH INJURIES (BLEEDING AND LIMB ISCHEMIA) TO THE IMPELLA DEVICE AND ELECTED TO REMOVE THE PUMP, SUBSEQUENTLY UPSIZING TO A 17 FR VA ECMO CANNULA VIA THE SAME ACCESS SITE. HEMOSTASIS REQUIRED REMOVAL OF THE IMPELLA DEVICE AND UPSIZING OF THE ACCESS SITE TO A 17 FR VA ECMO CANNULA. FOUR UNITS OF PRBCS WERE ADMINISTERED. FORWARD SUTURING AND GAUZE WERE UTILIZED; INTRODUCER PEEL AWAY OCCURRED OUTSIDE THE BODY. THESE COMPLICATIONS OF BLEEDING AND ISCHEMIA ARE CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT SURVIVED THE EVENT AND THE IMPELLA EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274714 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026770836 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention