BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25261144 · Received May 22, 2026

    Report

    Report Number
    1220648-2026-08136
    Event Type
    Death
    Date Received
    May 22, 2026
    Date of Event
    May 15, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    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

    D10 UPDATED. THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 0

    A 71-YEAR-OLD MALE WITH A PRE-SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE D UNDERWENT HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) WITH PLANNED IMPELLA CP SUPPORT VIA LEFT AXILLARY ARTERY DIRECT STICK ACCESS WITHOUT GRAFT PLACEMENT FOLLOWING MULTIDISCIPLINARY RISK-BENEFIT DISCUSSION. DURING THE PROCEDURE, FOLLOWING DRUG-COATED BALLOON (DCB) TREATMENT OF THE RIGHT CORONARY ARTERY (RCA), THE PATIENT DEVELOPED PULSELESS ELECTRICAL ACTIVITY REQUIRING CARDIOPULMONARY RESUSCITATION WITH RETURN OF SPONTANEOUS CIRCULATION (ROSC). POST-INTERVENTION, LOSS OF FLOW IN THE RCA WAS NOTED AND TRANSIENTLY IMPROVED WITH INTRACORONARY EPINEPHRINE; HOWEVER, THE PATIENT EXPERIENCED A SECOND CARDIAC ARREST WITH ROSC ACHIEVED. DUE TO CLINICAL INSTABILITY, THE DECISION WAS MADE TO MAINTAIN IMPELLA SUPPORT, ADVANCE A REPOSITIONING SHEATH INTO THE AXILLARY ARTERY, AND PROCEED WITH TRANSFER. SIGNIFICANT ACCESS SITE BLEEDING FROM THE AXILLARY ARTERIOTOMY OCCURRED FOLLOWING PEEL-AWAY REMOVAL, IN THE SETTING OF ANTICOAGULATION (BIVALIRUDIN, ACT VALUES 320¿350) AND UNDERLYING COAGULOPATHY, REQUIRING SURGICAL INTERVENTION, SUTURING, PLACEMENT OF A JP DRAIN, PRESSURE DRESSING, BLOOD PRODUCT ADMINISTRATION (INCLUDING FFP), AND EVENTUAL EMERGENT OPERATIVE MANAGEMENT AT THE RECEIVING FACILITY. HEMOSTASIS WAS ULTIMATELY PURSUED SURGICALLY. THROUGHOUT SUPPORT, THE IMPELLA CP FUNCTIONED AS INTENDED AT P-6 DELIVERING APPROXIMATELY 2.6 L/MIN WITH SODIUM BICARBONATE PURGE SOLUTION. DESPITE CONTINUED MANAGEMENT, THE PATIENT¿S CONDITION DETERIORATED, AND THE FAMILY ELECTED TO WITHDRAW CARE ON (B)(6) 2026; THE PATIENT SUBSEQUENTLY EXPIRED WITH THE DEVICE IN PLACE. BASED ON THE AVAILABLE INFORMATION, THE CASE DESCRIBES ACCESS SITE BLEEDING FROM THE AXILLARY ARTERY FOLLOWING DIRECT STICK IMPELLA CP INSERTION WITHOUT GRAFT, REQUIRING SURGICAL INTERVENTION IN THE CONTEXT OF ANTICOAGULATION AND COAGULOPATHY. THE IMPELLA DEVICE FUNCTIONED AS INTENDED WITH NO REPORTED PERFORMANCE ISSUES; HOWEVER, THE PATIENT EXPERIENCED SIGNIFICANT BLEEDING COMPLICATIONS ATTRIBUTED TO THE ACCESS SITE AND ULTIMATELY EXPIRED FOLLOWING WITHDRAWAL OF CARE. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA BUT IS UNLIKELY RELATED AND IS MOST LIKELY ATTRIBUTED TO PATIENTS UNDERLYING CRITICAL CONDITION AS THEY PRESENTED IN ENDING SCAI STAGE D SHOCK ON MULTIPLE INOTROPES AND PRESSORS AND WAS VENTILATED FOR RESPIRATORY SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322401 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027867502 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1