BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 371 14F LT CMR SET

    MDR report key: 24558802 · Received March 10, 2026

    Report

    Report Number
    1220648-2026-04894
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    October 2, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DIFFICULT TO ADVANCE: THE ROOT CAUSE OF THE DIFFICULTY IN ADVANCING THE PUMP WAS MOST LIKELY PATIENT CONDITION RELATED OWING TO THE PATIENT'S ANATOMY BASED ON THE PROVIDED CLINICAL DETAILS. PLACEMENT SIGNAL ISSUE: THE ROOT CAUSE OF THE PLACEMENT SIGNAL ISSUE WAS MOST LIKELY SENSOR BREAK LIKELY DUE TO SHOCKWAVE INTERACTION BASED ON THE PROVIDED CLINICAL DETAILS AND DATA LOG ANALYSIS.

    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

    A 73 YEAR-OLD MALE WITH A HISTORY OF CORONARY ARTERY DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, AND LEFT BELOW-KNEE AMPUTATION WAS EVALUATED FOR CORONARY ARTERY BYPASS GRAFT SURGERY AND DETERMINED NOT TO BE A SURGICAL CANDIDATE. THE PATIENT WAS ADMITTED FOR HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION WITH PLANNED CIRCULATORY SUPPORT USING AN IMPELLA CP DEVICE. DURING THE PROCEDURE, THE IMPELLA CP WAS INSERTED THROUGH THE COMMON FEMORAL ARTERY BUT COULD NOT BE ADVANCED INTO THE AORTA. THE DEVICE WAS REMOVED, AND A SECOND ATTEMPT AT ADVANCEMENT WAS MADE, WHICH WAS ALSO UNSUCCESSFUL. A NEW IMPELLA CP DEVICE WAS THEN INSERTED HOWEVER, DIFFICULTY WAS AGAIN ENCOUNTERED ADVANCING THE DEVICE INTO THE DESCENDING AORTA. ON A SUBSEQUENT ATTEMPT, THE NEW IMPELLA CP DEVICE WAS SUCCESSFULLY ADVANCED INTO THE DESCENDING AORTA AND POSITIONED APPROPRIATELY WITHIN THE LEFT VENTRICLE. DURING THE PERCUTANEOUS CORONARY INTERVENTION, INTRAVASCULAR SHOCKWAVE THERAPY WAS APPLIED TO AN OSTIAL LEFT MAIN CORONARY ARTERY LESION. AT THAT TIME, THE OPTICAL SENSOR OF THE IMPELLA CP DEVICE BECAME NONFUNCTIONAL. DESPITE LOSS OF OPTICAL SENSOR SIGNAL, THE IMPELLA CP CONTINUED TO PROVIDE CIRCULATORY SUPPORT AND OPERATED WITHOUT INTERRUPTION FOR THE REMAINDER OF THE PROCEDURE. AFTER COMPLETION OF THE CORONARY INTERVENTION AND CONFIRMATION OF SATISFACTORY RESULTS BY THE TREATING PHYSICIAN, THE IMPELLA CP DEVICE WAS GRADUALLY WEANED AND SUCCESSFULLY EXPLANTED WITHOUT COMPLICATION OR CONCERN. THE DIFFICULTY IN IMPELLA PASSING INTO THE AORTA IS MORE LIKELY CAUSED BY THE PATIENT¿S AORTIC ANATOMY/STRUCTURE, WHICH CAUSED DIFFICULTY EVEN AFTER EXCHANGING THE PUMP. NO DEVICE MALFUNCTION AFFECTING CIRCULATORY SUPPORT WAS REPORTED, AND MANAGEMENT DECISIONS WERE BASED ON PROCEDURAL AND CLINICAL CONSIDERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136607 PUMP 371 14F LT CMR SET TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026732857 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1