BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24114879 · Received January 20, 2026

    Report

    Report Number
    1220648-2026-01114
    Event Type
    Death
    Date Received
    January 20, 2026
    Date of Event
    January 12, 2026
    Report Date
    March 14, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    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

    A6 IS UNKNOWN. 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

    UPDATED INFORMATION: D4 CATALOG NUMBER UPDATED. H6 CLINICAL CODE E0303 REMOVED AND ADDED E1302.

    Additional Manufacturer Narrative · 0

    B5 REVISED TO INCLUDE CLINICAL RATIONALE.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: H6 COMPONENT CODES UPDATED. THE INVESTIGATION FOR THE HEMATURIA AND ACCESS SITE BLEEDING HAS BEEN COMPLETED. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND NO DEVICE RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA 5.5 HAD HEMATURIA THAT BEGAN PRIOR TO IMPLANTATION OF THE PUMP AND CONTINUED AFTER IMPLANTATION. THE PATIENT ALSO HAD BLEEDING FROM THE ACCESS SITE AND COMPARTMENT SYNDROME IN THE CHEST. CARE WAS WITHDRAWN AND THE PATIENT EXPIRED.

    Description of Event or Problem · 0

    A 21-YEAR-OLD MALE WITH ACUTE MYOCARDIAL INFARCTION/ CARDIOGENIC SHOCK WAS SUPPORTED WITH AN IMPELLA 5.5 DEVICE IMPLANTED VIA RIGHT AXILLARY/SUBCLAVIAN SURGICAL ARTERIAL ACCESS ON (B)(6) 2026 AT 11:37 PM EXPERIENCED HEMOLYSIS, ACCESS SITE BLEED AND EXPIRED BASED ON THE LIMITED INFORMATION AVAILABLE, THE PATIENT HAD HEMATURIA (PINK/RED URINE) PRIOR TO IMPLANTATION OF THE IMPELLA 5.5, INDICATING A PRE-EXISTING CLINICAL CONDITION. FOLLOWING DEVICE SUPPORT, THE PATIENT CONTINUED TO EXHIBIT PINK/RED URINE. CLINICAL STAFF LATER DOCUMENTED BLEEDING AT THE IMPELLA INSERTION SITE AND REPORTED ¿COMPARTMENT SYNDROME¿ IN THE CHEST, ALTHOUGH NO DETAILS WERE PROVIDED REGARDING IMAGING, INTERVENTIONS, OR SURGICAL EVALUATIONS. THERE WERE NO REPORTED IMPELLA ALARMS, ABNORMAL PUMP BEHAVIOR, OR ABNORMAL PURGE PARAMETERS, AND NO DIAGNOSTICS INDICATING DEVICE MALFUNCTION WERE DESCRIBED. THE PATIENT¿S CONDITION CONTINUED TO DETERIORATE, AND THE FAMILY ELECTED TO WITHDRAW CARE, AFTER WHICH THE PATIENT EXPIRED. THE PRESENCE OF HEMATURIA PRIOR TO DEVICE INSERTION AND THE LACK OF DEVICE ALARMS OR DOCUMENTED MECHANICAL ISSUES LIMIT THE ABILITY TO ATTRIBUTE THE CLINICAL OUTCOME TO DEVICE PERFORMANCE. BLEEDING WAS NOTED AND THIS IS A KNOWN RISK PER OUR IFU BECAUSE OF OUR ANTICOAGULATION AND PURGE REQUIREMENTS. HEMOLYSIS IS NOTED AS A RISK IN OUR IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466205 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026772523

    Patients

    Seq Age Sex Outcome Treatment
    1