BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24617039 · Received March 17, 2026

    Report

    Report Number
    1220648-2026-05428
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    March 9, 2026
    Report Date
    March 17, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. CORRECTED INFORMATION HAS BEEN PROVIDED IN D1; D3(MANUFACTURER FAX); D4(SERIAL); E4 THE CAUSE OF THE BLEEDING ISSUE WAS MOST LIKELY USE RELATED DUE TO THE PHYSICIAN DECIDED NOT TO PLACE FORWARD TENSION SUTURES DESPITE RECOMMENDATION, AND BLEEDING SITE CLEANED, PUMP WAS REPOSITIONED FOR ANGLE MATCHING AND HEMOSTASIS ACHIEVED.

    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 WAS INSERTED VIA RIGHT FEMORAL ARTERY IN A 78 YEAR OLD MALE FOR HIGH RISK PERCUTANEOUS CORONARY INTERVENTION. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE E. THE PATIENT RECEIVED SUPPORT FROM THE CP FOR CORONARY ANGIOPLASTY. THE PHYSICIAN HAD DECIDED NOT TO PLACE FORWARD TENSION SUTUTES DESPITE RECOMMENDATION. A FIGURE 8 STITCH HAD BEEN APPLIED ALONG WITH A FEMSTOP. POST-PROCEDURE, UPON ARRIVAL TO THE INTENSIVE CARE UNIT, BLEEDING WAS NOTED FROM THE GROIN SITE. THE DRESSING WAS REMOVED AND SITE CLEANED. THE PUMP WAS REPOSITIONED FOR ANGLE MATCHING, WHICH ACHIEVED HEMOSTASIS. ON DAY 3 OF SUPPORT, THE DEVICE WAS EXPLANTED SUCCESSFULLY. THIS EVENT IS CONSERVATIVELY REPORTED AS BLEEDING PROMPTED INTERVENTION, BUT THERE WAS NO LASTING HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284871 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026655056 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1