BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP

    MDR report key: 19221497 · Received May 1, 2024

    Report

    Report Number
    1220648-2024-10643
    Event Type
    Injury
    Date Received
    May 1, 2024
    Date of Event
    July 1, 2018
    Report Date
    July 5, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE PIGTAIL DETACHMENT HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CANNULA/ PIGTAIL DETACHMENT ISSUE WAS NOT DETERMINED SINCE THE PRODUCT WAS NOT RETURNED AND INSUFFICIENT CLINICAL INFORMATION AND CASE INFORMATION WAS PROVIDED. LITERATURE CITATION: COROMILAS, E. J., TAKEDA, K., ANDO, M., CEVASCO, M., GREEN, P., KARMPALIOTIS, D., KIRTANE, A., TOPKARA, V. K., YUZEFPOLSKAYA, M., TAKAYAMA, H., NAKA, Y., BURKHOFF, D., COLOMBO, P. C., & GARAN, A. R. (2019). COMPARISON OF PERCUTANEOUS AND SURGICAL RIGHT VENTRICULAR ASSIST DEVICE SUPPORT AFTER DURABLE LEFT VENTRICULAR ASSIST DEVICE INSERTION. JOURNAL OF CARDIAC FAILURE, 25(2), 105¿113. HTTPS://DOI.ORG/10.1016/J.CARDFAIL.2018.12.005 B.1 PRODUCT PROBLEM WAS SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10643 AND SHOULD NOT HAVE BEEN B.5 REVISED TO REFLECT ONLY ONE PATIENT SINCE THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10643 WAS SUBMITTED. G.1 REVISED REPORTING CONTACT FAX NUMBER IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10643 WAS SUBMITTED. H.6 CODES 1158 AND 925 WERE REPORTED INCORRECTLY ON MANUFACTURER DEVICE REPORT 1220648-2024-10643. H.10 A.1, A.4 AND A.5 ARE UNKNOWN STATEMENT AND LITERATURE CITATION WERE INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10643. ATTACHMENTS: PUBLICATION WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10643.

    Additional Manufacturer Narrative · 0

    D.14 CATALOG NUMBER, SERIAL NUMBER, LOT NUMBER, EXPIRATION DATE AND UNIQUE IDENTIFIER (UDI) # ARE UNKNOWN. H.4 DEVICE MANUFACTURE DATE IS UNKNOWN. D.6A AND D.6B IMPLANT AND EXPLANT DATES ARE UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. IMPELLA RP SMART ASSIST SYSTEM WITH AUTOMATED IMPELLA CONTROLLER. SECTION: WARNINGS & CAUTIONS: WARNINGS. ¿HANDLE WITH CARE. THE IMPELLA RP WITH SMARTASSIST SYSTEM CATHETER CAN BE DAMAGED DURING REMOVAL FROM PACKAGING, PREPARATION, INSERTION, AND REMOVAL. DO NOT BEND, PULL, OR PLACE EXCESS PRESSURE ON THE CATHETER OR MECHANICAL COMPONENTS AT ANY TIME.¿

    Description of Event or Problem · 0

    THIS REPORT WILL REPRESENT THE PATIENT THAT THE IMPELLA RP DEVICE FRACTURED ON REMOVAL AND ALL COMPONENTS OF THE DEVICE WERE REMOVED PERCUTANEOUSLY WITHOUT INCIDENT. MANUFACTURE DEVICE REPORT 1220648-2024-12947 REPRESENTS THE PATIENT THAT HAD TO RETURN TO THE CATHETERIZATION LAB FOR REPOSITIONING.

    Description of Event or Problem · 0

    A LITERATURE REVIEW WAS PERFORMED, AND A PUBLICATION WAS FOUND INCLUSIVE OF A IMPELLA RP REVIEW OF CASES FROM 2007 TO 2018 PUBLISHED/AUTHORED BY THE TEAM AT NEW YORK PRESBYTERIAN COLUMBIA. IN THE REVIEW, TWO COMPLAINTS WERE NOTED. THERE WAS A PATIENT WHO WITH IMPELLA RP REMOVAL, THE IMPELLA RP FRACTURED, AND THE TEAM WAS SUCCESSFUL IN REMOVING ALL PARTS OF THE PUMP FROM NATIVE PATIENT VASCULATURE. ANOTHER PATIENT HAD TO BE RETURNED TO THE CATHETERIZATION LAB FOR IMPELLA RP MALPOSITIONING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172550 IMPELLA RP TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Required Intervention