BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24852111 · Received April 11, 2026

    Report

    Report Number
    1220648-2026-06631
    Event Type
    Injury
    Date Received
    April 11, 2026
    Date of Event
    April 3, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. RELATED MEDICAL DEVICE REPORTS: THIS IMPELLA CP DEVICE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE INTRODUCER.

    Additional Manufacturer Narrative · 0

    B5: ADDED ADDITIONAL INFORMATION REGARDING THE RETURN OF THE DEVICE FOR EVALUATION.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE 14FR INTRODUCER TO SUPPORT THE 65 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. THE PATIENT WAS KNOWN TO HAVE HAD A CARDIAC ARREST WITH CPR AND WAS ON INOTROPES AND VASOPRESSORS PRIOR TO THE PUMP PLACEMENT. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE CP WAS PLACED AFTER THE ANGIOPLASTY WAS PERFORMED AND PATIENT WAS INTUBATED. SHORTLY AFTER THE PATIENT MOVED AND SAT UPRIGHT AND CAUSED A HEMATOMA TO DEVELOP AT THE PUMP ACCESS SITE. THE PHYSICIAN PEELED AWAY THE 14FR AND ADVANCED THE PUMP AND SECURED THE REPOSITIONING SHEATH. THE HEMATOMA AND BLEED CONTINUED AND CONSULT MADE WITH VASCULAR SURGERY. THE DECISION WAS MADE TO EXPLANT THE CP PUMP ENTIRELY. THE HEMOSTASIS WAS ACHIEVED BY 2 PROGLIDES AND HOLD OF 1 HOUR. PATIENT SURVIVED. THE ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING, HOWEVER IN THIS CASE THE BLEED OCCURRED WITH THE OFF-LABEL MOVEMENT OF THE PATIENT. THE BEST PRACTICES FOR A SUPINE PATIENT WERE NOT FOLLOWED. THE PATIENT HAS SURVIVED.

    Description of Event or Problem · 0

    THE PRODUCT IS NOT AVAILABLE FOR RETURN; IT WAS DISPOSED OF BY THE CATHETERIZATION LABORATORY STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209979 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027843437 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1