BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25196930 · Received May 17, 2026

    Report

    Report Number
    1220648-2026-07930
    Event Type
    Injury
    Date Received
    May 17, 2026
    Date of Event
    May 11, 2026
    Report Date
    May 15, 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL REVIEWED THE FILE AND DETERMINED THE DEVICE WAS ERRONEOUSLY REPORTED. AFTER CLINICAL REVIEW, IT WAS DETERMINED THAT THERE IS NO REPORTABLE COMPLAINT AS THE 0.018" IMPELLA GUIDEWIRE OR THE IMPELLA PUMP WERE NEVER INSERTED IN THE BODY. THE REPORTING IS BEING REDACTED. PREVIOUS REPORTING SHOULD BE DISREGARDED, AND NO FURTHER REPORTS WILL BE SUBMITTED ACCORDINGLY.

    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

    IMPELLA CP WAS PLANNED TO BE INSERTED VIA RIGHT FEMORAL ACCESS SITE IN A 79-YEAR-OLD MALE FOR ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES INCLUDE AORTIC STENOSIS. THE PATIENT¿S CLINICAL STATE PRIOR TO ATTEMPTED INTERVENTION WAS REPORTED AS SCAI SHOCK STAGE D. AFTER INSERTION OF THE 14 FRENCH PEEL AWAY SHEATH, PHYSICIAN WAS UNABLE TO CROSS WITH DIAGNOSTIC WIRES AND CATHETERS AND DECISION WAS MADE TO ABORT PROCEDURE AND THE IMPELLA CP WAS NOT INSERTED INTO THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179834 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027859507 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1