BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25183332 · Received May 15, 2026

    Report

    Report Number
    1220648-2026-07887
    Event Type
    Death
    Date Received
    May 15, 2026
    Date of Event
    May 6, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011371
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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.

    Additional Manufacturer Narrative · 0

    B5: ADDED ADDITIONAL INFORMATION. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY: PDI (THROMBOEMBOLISM/RENAL FAILURE): THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    B2: ADDED DEATH AND DEATH DATE. B5: ADDED CLINICAL REVIEW. D6B: CORRECTED THE EXPLANT DATE. H1: CORRECTED TO DEATH. H6: OMITTED CODE E0506, F2303. ADDED E050304, F02.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 86 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE C SHOCK. PRIOR TO THE CP DELIVERY THE PATIENT WAS SUPPORTED BY AN INTRA-AORTIC BALLOON PUMP.THE PATIENT WAS KNOWN TO HAVE A GASTROINTESTINAL BLEED WITH SMALL AMOUNTS OF BLOOD STOOLS DUE TO RADIATION THERAPY. THE BLEED WAS PRE-EXISTING AND NOT ALLEGED DUE TO THE PUMP. THE PUMP PURGE DID NOT INCLUDE THE ANTICOAGULANT HEPARIN, RATHER SODIUM BICARBONATE. BLEEDING MAY BE EXACERBATED BY USE OF HEPARIN IN THE IMPELLA PURGE SYSTEM, BUT NOT IN THIS CASE.IT WAS NECESSARY TO ADD DIALYSIS TEMPORARILY DURING THE SUPPORT AND INFUSE BLOOD PRODUCTS BACK TO THE PATIENT. THE EXACT QUANTITY OF THE BLOOD PRODUCTS WAS NOT SHARED BY THE MEDICAL TEAM IN JAPAN, NOR HOW LONG THE DIALYSIS WAS DEEMED NECESSARY FOR RENAL FAILURE.THE PUMP REMAINS ON FOR SUPPORT. THE PATIENT HAS SURVIVED.

    Description of Event or Problem · 0

    HEPARIN WAS NOT ADDED TO THE PURGING SOLUTION. BLOOD TRANSFUSIONS WERE LISTED IN RELATION TO THE GI BLEED; HOWEVER, THIS WAS RELATED TO THE PATIENT'S ORIGINAL CONDITION.

    Description of Event or Problem · 0

    AT THE TIME OF REMOVAL, A THROMBUS WAS ATTACHED TO THE ENTIRE CP, BUT THE THROMBUS HAD NOT DISLODGED. AFTER THE IMPELLA REMOVAL AND WAS SHOWING SIGNS OF RECOVERY, BUT DIED OF VT ON MAY 12 WITH THE DOCTOR'S COMMENT THAT THE CAUSE OF VT IS UNKNOWN. (TRANSFUSION WAS NOTED BUT GI BLEED WAS PREEXISTING). THE PATIENT WAS ALIVE AT THE TIME OF EXPLANT, BUT THE OUTCOME WAS DEATH. THE DEATH IS BEING CONSERVATIVELY REPORTED; HOWEVER, BASED ON THE AVAILABLE INFORMATION, THE PATIENT¿S OUTCOME IS MOST CONSISTENT WITH THE UNDERLYING ACUTE MYOCARDIAL INFARCTION, CARDIOGENIC SHOCK, AND PRE-EXISTING GASTROINTESTINAL BLEEDING. CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 86 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE C SHOCK. PRIOR TO THE CP DELIVERY THE PATIENT WAS SUPPORTED BY AN INTRA-AORTIC BALLOON PUMP. THE PATIENT WAS KNOWN TO HAVE A GASTROINTESTINAL BLEED WITH SMALL AMOUNTS OF BLOOD STOOLS DUE TO RADIATION THERAPY. THE BLEED WAS PRE-EXISTING AND NOT ALLEGED DUE TO THE PUMP. THE PUMP PURGE DID NOT INCLUDE THE ANTICOAGULANT HEPARIN, RATHER SODIUM BICARBONATE. BLEEDING MAY BE EXACERBATED BY USE OF HEPARIN IN THE IMPELLA PURGE SYSTEM, BUT NOT IN THIS CASE. THE EVENT IS NOT REPORTABLE WITH INFORMATION KNOWN TO DATE. THE PUMP REMAINS ON FOR SUPPORT. THE PATIENT HAS SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329525 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027852269 00813502011371

    Patients

    Seq Age Sex Outcome Treatment
    1