BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 24028989 · Received January 9, 2026

    Report

    Report Number
    1220648-2026-00492
    Event Type
    Death
    Date Received
    January 9, 2026
    Date of Event
    November 20, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT INVESTIGATION CLOSURE. INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED. DEVICE IN WRONG POSITION: THE CAUSE OF THE POSITIONING ISSUE WAS DETERMINED TO BE AN UNINTENTIONAL USE ERROR AS THE PUMP WAS PULLED OUT OF POSITION SINCE INTERMITTENT IMPELLA IN AORTA ALARM OCCURRED DURING EMS GROUND TRANSPORT. DEVICE HISTORY LOT: DEVICE LOT: 1920537. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: DEVICE (SN: (B)(6)) PASSED ALL POST STERILE INSPECTION CHECKS.

    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

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT DURING EMERGENCY MEDICAL SERVICES (EMS) GROUND TRANSPORT, THERE WERE INTERMITTENT ¿IMPELLA IN AORTA¿ ALARMS. THEN UPON ARRIVAL IN ICU, ECHOCARDIOGRAM WAS PERFORMED AND IMPELLA INLET LOCATED AT ATRIOVENTRICULAR (AV) ANNULUS. THE DEVICE WAS ADVANCED AT 2CM, AND ADEQUATE WAVEFORMS AND FLOWS ACHIEVED. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED CRUSHING CHEST PAIN AT THE EMERGENCY DEPARTMENT. EKG REVEALED ANTERIOR ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). THE DOCTOR TOOK PATIENT TO CCL AFTER REVOKING DO NOT RESUSCITATE (DNR). FINDINGS SHOWED THAT 100% PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) OCCLUSION. THROMBECTOMY WAS PERFORMED AND 1 STENT WAS PLACED. AFTER THE PROCEDURE THE PATIENT EXPERIENCED HYPOTENSION AND RESPIRATORY DISTRESS, AN EMERGENT INTUBATION WAS PERFORMED, AND DURING INTUBATION THE PATIENT LOST PULSE THEN CARDIO PULMONARY RESUSCITATION (CPR) WAS INITIATED. IN ADDITION IMPELLA WAS PLACED PER BEST PRACTICE DURING CPR, 30 MINUTES OF CPR WAS PERFORMED AND 13 AMPOULES OF EPINEPHRINE WAS ADMINISTERED, AND RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED. PATIENT WAS TRANSPORTED TO INTENSIVE CARE UNIT (ICU), AND NOTED THAT IMPELLA IN AORTAA ALARMS INTERMITTENTLY ACTIVE. IN ECHOCARDIOGRAM THE IMPELLA APPEARED SHALLOW. THE DOCTOR ADVANCES IMPELLA AT 2CM, MEASURING 4.7 CM FROM AV ANNULUS. DUE TO ANATOMY, POSITION CONSIDERED EITHER DEEP OR SHALLOW; IC ELECTED TO LEAVE IT DEEP. NO ALARMS, WAVEFORMS GOOD. TB LOCKED AT 93 CM. THE ACCESS SITE WAS DRY, CLEAN AND INTACT, WITH NO OOZING OR HEMATOMA, AND PULSES OBTAINED BY DOPPLER. IT WAS PLANNED TO GIVE 24¿48 HOURS TO ASSESS NEUROLOGICAL RECOVERY BEFORE MAKING DECISIONS. IT WAS REPORTED THAT THE PATIENT EXPIRED AT EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89997 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026659277 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention| D