BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24702528 · Received March 26, 2026

    Report

    Report Number
    1220648-2026-06008
    Event Type
    Death
    Date Received
    March 26, 2026
    Date of Event
    March 17, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    UPON REVIEW, IT WAS IDENTIFIED THAT THE . MANUFACTURER FAX (D3) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE FAX NUMBER HAS NOW BEEN PROVIDED. CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 SERIAL NUMBER. CORRECTED/UPDATED A CONCOMITANT PRODUCT. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA¿CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 71-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE¿C, WITH A HISTORY OF DIABETES MELLITUS AND RENAL INSUFFICIENCY. A HEMATOMA DEVELOPED AT THE GROIN ACCESS SITE, UNCLEAR WHETHER SECONDARY TO IMPELLA¿CP PLACEMENT OR ECMO CANNULATION, AS THE PATIENT WAS ALSO CANNULATED FOR ECMO IN THE SAME LEG. ANTICOAGULATION WAS HELD. A SIGNIFICANT HEMOTHORAX WAS NOTED FOLLOWING CARDIOPULMONARY RESUSCITATION (CPR) IN THE SETTING OF PRESUMED HYPOVOLEMIA. ANTICOAGULATION CONTINUED TO BE HELD DUE TO ONGOING CHEST-TUBE OUTPUT. CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. THE REPORTED HEMATOMA IS CONSISTENT WITH ACCESS-SITE COMPLICATIONS AND MAY BE INFLUENCED BY MULTIPLE CANNULATIONS IN THE SAME LIMB, ANTICOAGULATION NEEDS, AND UNDERLYING CRITICAL ILLNESS. THE REPORTED HYPOVOLEMIA IS CONSISTENT WITH SEVERE HEMODYNAMIC INSTABILITY ASSOCIATED WITH CARDIOGENIC SHOCK AND MAY BE EXACERBATED BY BLEEDING COMPLICATIONS. THE REPORTED CARDIAC ARREST IS CONSISTENT WITH THE PATIENT¿S UNDERLYING AMI/CGS PHYSIOLOGY AND PROFOUND HEMODYNAMIC COMPROMISE. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTABLE TO THE SEVERITY OF THE UNDERLYING AMI/CGS AND MULTI-SYSTEM INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027824394 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Death| R EXTRACORPOREAL MEMBRANE OXYGENATION