BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24746824 · Received March 31, 2026

    Report

    Report Number
    1220648-2026-06188
    Event Type
    Death
    Date Received
    March 31, 2026
    Date of Event
    March 25, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    H6 CODES WAS UPDATED FROM A24 TO A01.

    Additional Manufacturer Narrative · 0

    UPON REVIEW, IT WAS IDENTIFIED THAT THE MANUFACTURER FAX (D3) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE FAX NUMBER HAS NOW BEEN PROVIDED. CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 SERIAL NUMBER. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE AIR EMBOLISM WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE CARDIAC PERFORATION/PATIENT DEVICE INTERACTION WAS DETERMINED TO BE PATIENT CONDITION RELATED SINCE THE CLINICAL NOTES OF PATIENT HAVING A VERY SMALL VENTRICULAR SPACE.

    Description of Event or Problem · 0

    CLINICAL REVIEW/RATIONALE: AN IMPELLA 5.5 WAS INSERTED VIA DIRECT LEFT SURGICAL AORTA IN A 64 YEAR OLD FEMALE ADMITTED FOR TYPE A AORTIC DISSECTION REPAIR. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. DURING THE HIGH RISK SURGERY, THE IMPELLA WAS ADVANCED THROUGH 10 MM HEMOSHIELD PLATINUM GRAFT THAT WAS SEWN TO THE ASCENDING AORTA EXITING THE LEFT SIDE THROUGH TUNNEL PLACED BY PHYSICIAN. THE PATIENT HAD A VERY SMALL VENTRICULAR SPACE AND THE IMPELLA PUNCTURED THROUGH THE LEFT VENTRICULAR(LV) WALL WHILE STILL ON BYPASS. THE IMPELLA WAS PULLED BACK INTO THE GRAFT AND THEN REMOVED AND PLACED INTO A BASIN OF STERILE WATER WHILE THE VENTRICULAR PERFORATION WAS REPAIRED. A LARGE AMOUNT OF AIR ENTERED THE VENTRICLE AND SUBSEQUENTLY CAUSED AN AIR EMBOLUS IN THE RIGHT CORONARY ARTERY (RCA). THE IMPELLA WAS RE-ADVANCED AFTER REPAIR WAS COMPLETE AND TURNED ON WITH OPTIMAL PLACEMENT, WITH RECOMMENDATION TO SHALLOW THE PUMP TO APPROXIMATELY 4 CM DUE TO PATIENTS VENTRICULAR CAVITY SIZE. PLACEMENT ON TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED 4.1 CM, HOWEVER THE RIGHT VENTRICLE STOPPED FUNCTIONING WHILE THE LV PERFORATION REPAIR WAS COMPLETED. THE SURGEON WENT BACK ON BYPASS, AND THE IMPELLA WAS PLACED IN SURGICAL MODE TO ATTEMPT TO RE-PERFUSE THE RCA AND CLEAR THE AIR EMBOLUS. DESPITE EFFORTS, THE RIGHT VENTRICLE DID NOT SHOW SIGNS OF FUNCTIONALITY AND THE PATIENT EXPIRED. THE REPORTED VASCULAR INJURY AND DEATH MAY OCCUR IN THE SETTING OF IMPELLA 5.5 SUPPORT AND PLACEMENT REQUIREMENTS, AND MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS THE UNDERLYING CARDIOGENIC SHOCK PHYSIOLOGY AND CRITICAL CONDITION, HEMODYNAMIC INSTABILITY, AND DEVICE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556368 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026738796 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1