BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 20682925 · Received November 14, 2024

    Report

    Report Number
    1220648-2024-23113
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    September 14, 2023
    Report Date
    September 16, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. A.1, A.2, A.3, A.4 AND A.5 ARE UNKNOWN. D.4 CATALOG NUMBER, SERIAL NUMBER, LOT NUMBER, EXPIRATION DATE AND UNIQUE IDENTIFIER (UDI) # ARE UNKNOWN. D.6A AND D.6B IMPLANT AND EXPLANT DATES ARE UNKNOWN. H.4 DEVICE MANUFACTURE DATE IS UNKNOWN. JANG, S.-J., MALAGUEZ WEBBER, F., ALAM, M. M., BAE, J. Y., AGGARWAL, A., THOMAS, A., ZARICH, S. W., AHMAD, T., MILLER, P. E., & DAVILA, C. D. (2023). EARLY CLINICAL OUTCOMES OF PATIENTS WITH STRESS-INDUCED CARDIOMYOPATHY RECEIVING ACUTE MECHANICAL SUPPORT IN THE US. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS, 2(6), 101185. HTTPS://DOI.ORG/10.1016/J.JSCAI.2023.101185.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF RENAL FAILURE AND VASCULAR DAMAGE - PERIPHERAL VESSEL HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT ADDITIONAL CLINICAL DETAILS, THE ROOT CAUSE OF THE REPORTED ISSUES COULD NOT BE DETERMINED. G1 REPORTING CONTACT EMAIL REVISED ON MANUFACTURER DEVICE REPORT 1220648-2024-23113 IN ACCORDANCE WITH UPDATED PROCEDURES.

    Description of Event or Problem · 0

    ABIOMED JAPAN FORWARDED THE PUBLICATION ENTITLED "EARLY CLINICAL OUTCOMES OF PATIENTS WITH STRESS-INDUCED CARDIOMYOPATHY RECEIVING ACUTE MECHANICAL SUPPORT IN THE US" WITH PRIMARY AUTHOR FROM YALE DOCUMENTED A REVIEW OF 902 PATIENTS, OF WHICH 189 HAD IMPELLA SUPPORT. IMPELLA WAS ASSOCIATED WITH AN INCREASED ADJUSTED RISK OF 30-DAY READMISSION COMPARED TO INTRA-AORTIC BALLOON PUMP (IABP) (AOR, 2.53; 95% CI, 1.16- 5.51). PATIENTS WITH EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)OR IMPELLA HAD A HIGHER INCIDENCE OF RENAL REPLACEMENT THERAPY AND VASCULAR/BLEEDING COMPLICATIONS COMPARED TO THOSE WHO RECEIVED IABP. CONCLUSIONS: IN THIS NATIONWIDE ANALYSIS USING AN ADMINISTRATIVE DATABASE, PATIENTS WHO RECEIVED ECMO AND IMPELLA SHOWED HIGHER RATES OF IN-HOSPITAL MORTALITY, RENAL REPLACEMENT THERAPY, AND VASCULAR/BLEEDING COMPLICATIONS COMPARED TO THOSE WHO RECEIVED IABP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217142 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Other