BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24915720 · Received April 17, 2026

    Report

    Report Number
    1220648-2026-06928
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    April 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. SERIAL CORRECTED. D6B. EXPLANTATION DAY, MONTH AND YEAR ADDED. H6. HEALTH EFFECT - CLINICAL CODE ADDED.

    Additional Manufacturer Narrative · 0

    A4 WEIGHT IS UNKNOWN. 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

    ADDED D3 MANUFACTURER FAX WAS OMITTED DURING INITIAL REPORT. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE PLACEMENT SIGNAL ISSUE COULD NOT BE DETERMINED. THE CAUSE OF THE HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD COULD NOT BE DETERMINED. THE CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: A 71-YEAR-OLD MALE WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRE-SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE E, WAS SUPPORTED WITH AN IMPELLA 5.5 IMPLANTED VIA RIGHT AXILLARY/SUBCLAVIAN SURGICAL ARTERIAL ACCESS ON (B)(6) 2026 AT 06:23. DURING ONGOING SUPPORT, THE CCU NURSE AND VAD ENGINEERS REPORTED A TREND OF DECREASING PURGE FLOW WITH INCREASING PURGE PRESSURE INTO THE 700S. THE CLINICAL TEAM ELECTED TO CHANGE THE PURGE SOLUTION FROM D5W WITH BICARBONATE TO A TPA-CONTAINING SOLUTION. AROUND THE SAME TIME AS THE PURGE PRESSURE INCREASE, DECOUPLING OF THE AORTIC PLACEMENT SIGNAL AND LEFT VENTRICULAR WAVEFORM WAS OBSERVED. THERE WAS CONCERN FOR HEMATURIA, AS THE PATIENT HAD BLOODY URINE OUTPUT NOTED THE PRIOR DAY; HOWEVER, PER NURSING ASSESSMENT AND REVIEW OF HEMOLYSIS LABORATORY VALUES, THERE WAS LOW CONCERN FOR HEMOLYSIS. UROLOGY WAS CONSULTED AND CONTINUED TO FOLLOW THE PATIENT. THE PATIENT REMAINED ANTICOAGULATED WITH A BIVALIRUDIN INFUSION, WHICH WAS NOTED AS A CONTRIBUTING CLINICAL FACTOR. THE COMPLAINT REMAINS OPEN PENDING CONTINUED SUPPORT, DATA REVIEW, AND ANY FUTURE DEVICE RETURN. THE PATIENT REMAINS ON SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404253 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027836112 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1