BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25150701 · Received May 12, 2026

    Report

    Report Number
    1220648-2026-07771
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    May 5, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 54-YEAR-OLD FEMALE PATIENT UNDERGOING HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI), PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE A. PATIENT HAS PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE, DIABETES, AND DIALYSIS. FOLLOWING PLACEMENT, PLACEMENT SIGNAL (PS) VALUES WERE NOTED TO BE DISCORDANT, WITH AN ARTERIAL MEAN ARTERIAL PRESSURE (MAP) OF 65 MMHG AND A PLACEMENT SIGNAL MAP OF 47 MMHG. PUMP POSITION WAS CONFIRMED BY RADIOGRAPHY. THE PATIENT WAS NOTED TO HAVE A SMALL LEFT VENTRICULAR CAVITY AND CALCIFIED AORTIC VALVE LEAFLETS. AFTER IMPELLA CP PLACEMENT, THE PATIENT BECAME HYPOTENSIVE, AND ONGOING PLACEMENT SIGNAL CONCERNS WERE OBSERVED. DURING ADVANCEMENT OF THE GUIDE CATHETER FOR PCI, THE TREATING PROVIDER IDENTIFIED WIDE-OPEN AORTIC INSUFFICIENCY. THE IMPELLA CP WAS REPOSITIONED UNDER FLUOROSCOPIC GUIDANCE, WITH THE CATHETER WITHDRAWN UNTIL THE PIGTAIL WAS WITHIN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) AND THEN RE-ADVANCED INTO THE MID-LEFT VENTRICULAR CAVITY. DESPITE REPOSITIONING, THE AORTIC INSUFFICIENCY COULD NOT BE CORRECTED. BASED ON THESE FINDINGS, A CLINICAL DECISION WAS MADE TO REMOVE THE IMPELLA CP DEVICE AND PROCEED WITH PCI WITHOUT MECHANICAL CIRCULATORY SUPPORT. THE PATIENT SUBSEQUENTLY UNDERWENT SUCCESSFUL STENTING OF THE PROXIMAL-MID LEFT ANTERIOR DESCENDING (P-MLAD) ARTERY WITHOUT FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207944 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027833147

    Patients

    Seq Age Sex Outcome Treatment
    1