BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25174184 · Received May 14, 2026

    Report

    Report Number
    1220648-2026-07839
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    May 8, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED: D3, D6B. 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

    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 INFORMATION WAS PROVIDED IN B2 (IS DEATH AND DATE OF DEATH) AND B5 TO CAPTURE THE NEW INFORMATION. CORRECTED INFORMATION WAS PROVIDED IN E1. UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. H1 TYPE OF REPORTABLE EVENT AND H6 HEALTH EFFECT - IMPACT CODE WERE UPDATED TO CAPTURE DEATH.

    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

    UPDATED CLINICAL NARRATIVE: (FROM AEI). WEEKS LATER AFTER THE REPORTED EVENTS, THE PATIENT SUBSEQUENTLY HAD CARE WITHDRAWN AND EXPIRED. THE DEATH IS CONSERVATIVELY BEING REPORTED; HOWEVER, IT IS MOST LIKELY ATTRIBUTABLE TO THE PATIENT¿S UNDERLYING ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE D), KNOWN CORONARY ARTERY DISEASE, DEVELOPMENT OF A VENTRICULAR SEPTAL DEFECT ASSOCIATED WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, AND ONGOING CRITICAL ILLNESS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA 5.5 WAS SURGICALLY PLACED VIA THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 64-YEAR-OLD FEMALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), WITH A PRE-SUPPORT CLINICAL CONDITION CONSISTENT WITH SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE D SHOCK. THE PATIENT WAS BRIDGED TO IMPELLA 5.5 SUPPORT FOR HEMODYNAMIC STABILIZATION. THE PATIENT¿S MEDICAL HISTORY WAS SIGNIFICANT FOR KNOWN CORONARY ARTERY DISEASE. DURING ONGOING SUPPORT, THE PATIENT REQUIRED TRANSFUSION OF TWO UNITS OF PACKED RED BLOOD CELLS DUE TO SANGUINEOUS OUTPUT FROM A CHEST TUBE PLACED FOR MANAGEMENT OF PLEURAL EFFUSIONS. ADDITIONALLY, A VENTRICULAR SEPTAL DEFECT WAS IDENTIFIED AND CONFIRMED BY IMAGING, WHICH THE TREATING PROVIDER ATTRIBUTED TO THE PATIENT¿S ADMITTING DIAGNOSIS OF ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). AT THE TIME OF THIS REPORT, THE PATIENT REMAINS ON IMPELLA 5.5 SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466489 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027855705 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1