BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 24468769 · Received February 27, 2026

    Report

    Report Number
    1220648-2026-04190
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    February 18, 2026
    Report Date
    February 27, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    D1. BRAND NAME UPDATED. D6B. EXPLANTATION DAY, MONTH AND YEAR ADDED.

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL EVENT INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMS THE IMPELLA PUMP PLACED FOR SUPPORT WAS EXPLANTED. THE PATIENT WAS REPORTED TO HAVE SURVIVED AT THE TIME OF EXPLANT AND WAS SUBSEQUENTLY BRIDGED TO DURABLE LEFT VENTRICULAR ASSIST DEVICE (D6B EXPLANT DATE DOCUMENTED IN FOLLOW-UP 2 REPORT WITH D6A IMPLANT DATE WERE REPOPULATED).

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT ON IMPELLA SUPPORT WITH A 5.5 PUMP. AXILLARY CUTDOWN PERFORMED, GRAFT SEWN IN NORMAL FASHION. ABLE TO PASS WIRE/CATHETER ACROSS VALVE AND EXCHANGED FOR 018 IN NORMAL FASHION. AT TIME OF PUMP ENTRY, PHYSICIAN REQUESTED TO INSERT DEVICE WITH ELBOW FACING TOWARDS FEET. DIFFICULTY PASSING THROUGH ANASTOMOSIS. AT THIS TIME, PUMP WAS REMOVED AND RE-ANGLED WITH ELBOW FACING HEAD. PUMP WOULD STILL THEN PASS. PHYSICIAN APPLIED SIGNIFICANT FORCE. INQUIRED ABOUT LIKELIHOOD OF WIRE KINKING. PHYSICIAN SAID IT IS NOT (KINKING) EXCEPT ARTERY BEING TOO SMALL. CONTINUED TO APPLY EXCESSIVE FORCE AND FINALLY GOT CATHETER ACROSS VALVE. WIRE REMOVED AND IMPELLA TURNED ON. WAVEFORMS AND FLOWS APPROPRIATE. PATIENT RETURNED TO ICU.

    Description of Event or Problem · 0

    PUMP HAS SINCE BEEN EXPLANTED AND DEVICE IS NOT AVAILABLE FOR RETURN. EXPLANT DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586022 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US 2026813005 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1