BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25229954 · Received May 20, 2026

    Report

    Report Number
    1220648-2026-08022
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    May 14, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    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

    B2: IS DEATH AND DATE OF DEATH ADDED. B5: ADDITIONAL EVENT DESCRIPTION ADDED. D6B: EXPLANTATION DAY, MONTH AND YEAR ADDED. H6: HEALTH EFFECT - IMPACT CODE ADDED.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED REPORTED SOME EPISODIC VT STORMING, IS ON LIDOCAINE AND AMIODARONE. EPISODES REPORTED TO BE SELF LIMITING AND NO SHOCKS REQUIRED. THEY DECLINED TO GET AN ECHO TO SEE IF THERE WAS ANY IMPLICATION OF THE IMPELLA. BEDSIDE RN REPORTS 1 UNIT PRBC OVERNIGHT. NO OVERT SIGNS OF BLEEDING. NO IMPLICATION OF IMPELLA. PATIENT EXPIRED AFTER WITHDRAWING CARE. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA 5.5 BUT IS UNLIKELY RELATED AND IS MOST LIKELY ATTRIBUTED TO PATIENTS UNDERLYING CRITICAL CONDITION AS THEY PRESENTED IN SCAI STAGE D SHOCK ON MULTIPLE INOTROPES AND PRESSORS AND WAS VENTILATED FOR RESPIRATORY SUPPORT.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 75-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT HAD A HISTORY OF DIABETES MELLITUS AND RENAL INSUFFICIENCY. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE D. DURING THE NIGHT SHIFT, EPISODIC VENTRICULAR TACHYCARDIA (VT) STORMING WAS REPORTED. THE PATIENT HAD A HISTORY OF VENTRICULAR TACHYCARDIA AND WAS ON LIDOCAINE AND AMIODARONE. THE EPISODES WERE SELF-LIMITING AND NO SHOCKS WERE REQUIRED. THE PHYSICIAN WAS ASKED IF IMAGING HAD BEEN PERFORMED TO ENSURE THE IMPELLA WAS NOT CAUSING ANY OF THE VENTRICULAR TACHYCARDIA BUT DECLINED TO OBTAIN AN ECHOCARDIOGRAM. THE PATIENT REMAINED ON SUPPORT. VENTRICULAR TACHYCARDIA MAY HAVE BEEN RELATED TO THE PATIENT'S UNDERLYING CARDIAC CONDITION AND HISTORY OF VENTRICULAR ARRHYTHMIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613041 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027882940

    Patients

    Seq Age Sex Outcome Treatment
    1