BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24474295 · Received February 27, 2026

    Report

    Report Number
    1220648-2026-04260
    Event Type
    Death
    Date Received
    February 27, 2026
    Date of Event
    February 18, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A4 WEIGHT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    HEMODYNAMIC INSTABILITY: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PLACEMENT SIGNAL ISSUE: THE CAUSE OF THE PLACEMENT SIGNAL ISSUE COULD NOT BE DETERMINED WITHOUT THE RETURNED PRODUCT FOR INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOG. DEVICE IN WRONG POSITION: THE CAUSE OF THE POSITIONING ISSUE COULD NOT BE DETERMINED WITHOUT THE RETURNED PRODUCT FOR INVESTIGATION AND SUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    B1. BRAND NAME UPDATED. H6. MEDICAL DEVICE PROBLEM CODE ADDED.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA CP DEVICE WAS INSERTED INTO THE LEFT FEMORAL ARTERY IN A 71-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) AND DIABETES, PRESENTING IN AN OUT-OF-HOSPITAL CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR), IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), AND IN SCAI STAGE C SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. DURING THE PROCEDURE, THE PATIENT WAS IN CARDIAC ARREST AND CPR WAS INITIATED. AN IMPELLA CP WAS THEN INSERTED, BUT STARTED TO HAVE IMPELLA IN AORTA AND IMPELLA IN VENTRICLE ALARMS. THE PHYSICIAN ATTEMPTED TO REPOSITION THE IMPELLA UNDER FLUOROSCOPY, BUT WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO REPLACE THE IMPELLA CP WITH A NEW IMPELLA CP. CPR CONTINUED, BUT THE PATIENT EXPIRED ON SUPPORT IN THE PROCEDURE ROOM. THE DEVICE IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, AS THE PATIENT WAS ALREADY IN CARDIAC ARREST, PRIOR TO THE IMPELLA PLACEMENT. THE DEATH WAS MOST LIKELY DUE TO THE PATIENT'S PRE-EXISTING CONDITION OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK, ALONG WITH THE COMPLICATIONS OF STAGE C SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541907 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027820510 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| D