BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25150658 · Received May 12, 2026

    Report

    Report Number
    1220648-2026-07768
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    May 7, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. PRIMARY UDI NUMBER, EXPIRATION DATE, AND LOT ARE UNKNOWN. H4. DEVICE MANUFACTURE DATE IS UNKNOWN. 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

    COMPLAINT CODING WAS UPDATED TO MORE ACCURATELY REFLECT THE REPORTED EVENT. THE APPROPRIATE CODES ARE AS FOLLOWS FOR H6 AND HAVE BEEN FULLY UPDATED AND SHOULD BE CONSIDERED REPRESENTATION OF THE REPORTED EVENT. H6 HEALTH EFFECT - CLINICAL CODE E0506 ADD AND E2403 REMOVED. H6 MEDICAL DEVICE PROBLEM CODE A01 ADDED.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN AN 82-YEAR-OLD MALE PATIENT PRESENTING WITH HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI). THE PATIENT HAD A HISTORY OF KNOWN CORONARY ARTERY DISEASE. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE A. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE 14F SHEATH DIAPHRAGM WAS LEAKING AROUND THE 7F COMPANION SHEATH. THE COMPANION SHEATH WAS REPLACED WITH A 7F X 25 CM TERUMO PINNACLE SHEATH, WHICH RESOLVED THE LEAKING. THE DEVICE 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 WITHOUT ANY KNOWN ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217120 IMPELLA INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1