BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24764905 · Received April 2, 2026

    Report

    Report Number
    1220648-2026-06290
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 25, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4 CATALOG NUMBER WAS CORRECTED. SECTION D4 SERIAL NUMBER WAS CORRECTED. SECTION D4 PRIMARY UDI NUMBER HAS BEEN UPDATED. INVESTIGATION SUMMARY: HEMATURIA: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE IN WRONG POSITION: THE CAUSE OF THE DEVICE IN WRONG POSITION WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    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

    AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 67-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE C, WITH A HISTORY OF KNOWN CORONARY ARTERY DISEASE, DIABETES MELLITUS, AND RENAL INSUFFICIENCY. WHEN THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS PLUGGED INTO A WALL POWER OUTLET, STAFF HEARD A LOUD "POP" AND OBSERVED A FLASH OF LIGHT. THE AIC SUBSEQUENTLY FAILED TO CHARGE WHEN CONNECTED TO AC POWER, AND STAFF NOTED A LOOSE WIRE WITHIN THE AC PLUG. THE AIC WAS REPLACED. FOLLOWING THE CONTROLLER EXCHANGE, RED-TINGED URINE WAS NOTED. ECHOCARDIOGRAPHY DEMONSTRATED THE IMPELLA POSITIONED IN THE CHORDAE, AND THE DEVICE WAS REPOSITIONED BY THE PHYSICIAN. AFTER REPOSITIONING, THE ISSUE RESOLVED. THE PATIENT SURVIVED TO EXPLANT. THE AIC WILL BE CONSERVATIVELY REPORTED FOR SERIOUS INJURY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE; HOWEVER, THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT, AND SUPPORT WAS RESUMED. THE REPORTED HEMATURIA REQUIRING DEVICE REPOSITIONING IS CONSISTENT WITH HEMOLYSIS-ASSOCIATED FINDINGS THAT MAY OCCUR IN THE SETTING OF SUBOPTIMAL DEVICE POSITION AND UNDERLYING AMI/CGS PHYSIOLOGY AND RESOLVED FOLLOWING CORRECTION OF IMPELLA POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608851 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027843300 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1