BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 24740643 · Received March 31, 2026

    Report

    Report Number
    1220648-2026-06028
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 20, 2026
    Report Date
    March 27, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10 RELATED REPORT NUMBER WAS ADDED. THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENT THE IMPELLA CP AND ANOTHER REPORT WAS SUBMITTED TO REPRESENT THE INTRODUCER.

    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

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 (CATALOG & SERIAL). FAILURE TO ADVANCE : THE CAUSE OF THE DELIVERY ISSUE WAS DETERMINED TO BE PATIENT CONDITION RELATED TO THE PATIENT¿S BILATERAL ILIAC ARTERY STENOSIS WITH STENTING AND LEFT COMMON FEMORAL/ILIAC SEVERELY DISEASED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS TO BE IMPLANTED WITH AN IMPELLA CP VIA PERCUTANEOUS RIGHT FEMORAL ARTERY FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT WITH KNOWN BILATERAL ILIAC ARTERY STENOSIS WITH STENTING. LEFT COMMON FEMORAL/ILIAC WAS SEVERELY DISEASED. ACCESS WAS OBTAINED ON THE RIGHT COMMON FEMORAL ARTERY FOLLOWED BY ANGIOGRAM AND SHOCKWAVE THERAPY TO THE RIGHT ILIAC ARTERY TO TREAT AREAS WITH SIGNIFICANT STENOSIS. POST SHOCKWAVE, THE CARDIOLOGIST WAS UNABLE TO FULLY ADVANCE THE ABIOMED 25 CENTIMETER (CM) PEEL-AWAY SHEATH DUE TO SIGNIFICANT RESISTANCE, SO INSTEAD AN ABIOMED 13 CM PEEL-AWAY SHEATH WAS UTILIZED AND WAS FULLY INSERTED INTO THE VESSEL WITHOUT DIFFICULTY. THE IMPELLA WAS THEN ADVANCED THROUGH THE PEEL-AWAY SHEATH AND FULLY INSERTED INTO THE PATIENT¿S BODY BUT WAS UNABLE TO ADVANCE IT PAST THE LEVEL OF THE ILIAC ARTERY. THE IMPELLA WAS REMOVED, PLACED IN A BOWL OF STERILE SOLUTION AND RINSED. THE CARDIOLOGIST PROCEEDED WITH SHOCKWAVE PERIPHERAL INTRAVASCULAR LITHOTRIPSY ONCE AGAIN. A SECOND ATTEMPT AT PLACING THE IMPELLA WAS MADE BUT WITH NO SUCCESS AT ADVANCING THE IMPELLA PAST THE ILIAC ARTERY. AT THIS POINT THE PHYSICIAN DECIDED TO ABORT IMPELLA PLACEMENT AND PROCEEDED WITH PERCUTANEOUS CORONARY INTERVENTION WITHOUT IMPELLA SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281343 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027848771 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1