BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24780560 · Received April 3, 2026

    Report

    Report Number
    1220648-2026-06390
    Event Type
    Death
    Date Received
    April 3, 2026
    Date of Event
    March 27, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENT THE IMPELLA CP AND ANOTHER REPORT WILL BE SUBMITTED TO REPRESENT THE INTRODUCER. 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 INFORMATION REGARDING THE RELATED DEVICE. H10: ADDED THE DEVICE REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D3 AND E1. UPON REVIEW, IT WAS IDENTIFIED THAT THESE INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4. UPON REVIEW, THE SERIAL AND PRIMARY UDI NUMBER HAVE BEEN UPDATED. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF PUMP WRONG POSITION WAS MOST LIKELY PATIENT RELATED SINCE PER CLINICAL THE PUMP WAS UNABLE TO BE PROPERLY POSITIONED DUE TO PATIENT LARGE BODY HABITUS AND PEEL AWAY LEFT IN PLACE.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE 14FR INTRODUCER SHEATH AT THE FEMORAL ARTERY TO SUPPORT THE 50 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. THE PATIENT'S UNDERLYING MEDICAL HISTORY WAS NOT SHARED, BUT THE PATIENT WAS KNOWN TO HAVE HAD A CARDIAC ARREST WITH CPR PRIOR, AND WAS PREVIOUSLY SUPPORTED BY INOTROPES, VASOPRESSORS, AND A VENT FOR RESPIRATORY NEEDS PRIOR TO PUMP IMPLANT. THE TEAM PLACED THE CP BUT, DID NOT FOLLOW THE INSTRUCTIONS FOR USE AND DID NOT REMOVE THE 14FR INTRODUCER. THE 14FR WAS RETAINED WITHIN THE ARTERY DUE TO THE LARGE BODY HABITUS. THE CP WAS SUPPORTING WHEN THERE WAS OBSERVED HEMATURIA. THE TEAM WOULD NOT REPOSITION THE PUMP TO REDUCE THE HEMATURIA AND CHANCE OF HEMOLYSIS DEVELOPING. THE POSITIONAL ISSUES WERE ATTRIBUTED TO THE PATIENT'S ANATOMY. AFTER 2 DAYS ON THE SUPPORT THE DECISION WAS MADE TO WITHDRAW CARE AND ALLOW THE PATIENT TO EXPIRE. 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 E.

    Description of Event or Problem · 0

    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 IMPELLA INTRODUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63620 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027821944 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1