BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24578672 · Received March 12, 2026

    Report

    Report Number
    1220648-2026-05134
    Event Type
    Death
    Date Received
    March 12, 2026
    Date of Event
    March 4, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Removal / Correction Number
    95129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 REVISED.

    Additional Manufacturer Narrative · 0

    D4 (PRIMARY UDI NUMBER) HAS BEEN UPDATED. HYPOTENSION/CARDIAC ARREST: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. ACCESS SITE ADVERSE EVENT/HEMATOMA/MAJOR BLEED: SINCE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND LIMITED CLINICAL DETAILS WERE PROVIDED, THE CAUSE OF THE ACCESS SITE ADVERSE EVENT COULD NOT BE DETERMINED. LOW OR BLOCKED PUMP FLOW: BASED ON THE CLINICAL DETAILS PROVIDED THAT THE PATIENT HAD A MAJOR BLEED AT THE TIME OF THE COMPLICATION, THE CAUSE OF THE LOW PUMP FLOWS WAS MOST LIKELY A RESULT OF THE PATIENT'S CONDITION.

    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

    THIS SUPPLEMENTAL REPORT CORRECTS INFORMATION PREVIOUSLY REPORTED IN SECTION H9. UPON REVIEW, THE EVENT WAS DETERMINED TO HAVE BEEN INCORRECTLY ASSOCIATED WITH A RECALL. BASED ON THE CURRENT EVALUATION, THE EVENT IS NOT ASSOCIATED WITH ANY RECALL.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D1. HYPOTENSION/CARDIAC ARREST: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. ACCESS SITE ADVERSE EVENT/HEMATOMA/MAJOR BLEED: SINCE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND LIMITED CLINICAL DETAILS WERE PROVIDED, THE CAUSE OF THE ACCESS SITE ADVERSE EVENT COULD NOT BE DETERMINED. LOW OR BLOCKED PUMP FLOW: BASED ON THE CLINICAL DETAILS PROVIDED THAT THE PATIENT HAD A MAJOR BLEED AT THE TIME OF THE COMPLICATION, THE CAUSE OF THE LOW PUMP FLOWS WAS MOST LIKELY A RESULT OF THE PATIENT'S CONDITION.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 85 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE AND WITH PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). PRIOR TO THE SUPPORT THE PATIENT WAS ON INOTROPES AND VASOPRESSORS, AND HAD PRESENTED IN SCAI STAGE D SHOCK. THE OTHER MEDICAL HISTORY WAS NOT SHARED. THE PCI WAS PERFORMED AND THE PATIENT WAS SENT TO THE ICU ON THE CP FOR CONTINUED SUPPORT. THE PATENT CONDITION DETERIORATED IN THE ICU AS THE PATIENT BECAME HYPOTENSIVE, LOST PULSATILITY, AND SUCTION OCCURRED. VOLUME WAS GIVEN TO TROUBLESHOOT BUT, CONDITION DID NOT IMPROVE AS WITH EACH INFUSION THE ISSUE WOULD ONLY RESOLVE TEMPORARILY. THE TEAM SENT THE PATIENT FOR CT IMAGING TO LOCATE A POSSIBLE BLEED AND DISCOVERED A HEMATOMA UNDER THE MUSCULATURE THAT WAS NOT FELT/APPRECIATED AT THE GROIN. THEY GAVE 8 UNITS OF BLOOD, PUMP WAS EXPLANTED, AND MANY ROUNDS OF ACLS WERE APPLIED. THE PATIENT CONTINUED TO CODE AND EXPIRED AFTER THE PUMP EXPLANT. HEMOSTASIS WAS NOT ACHIEVED. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING, SUCH AS THIS HEMATOMA. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28391 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026781967 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Death