BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP

    MDR report key: 7006583 · Received November 7, 2017

    Report

    Report Number
    1220648-2017-00094
    Event Type
    Injury
    Date Received
    November 7, 2017
    Date of Event
    October 13, 2017
    Report Date
    October 16, 2017
    Manufacturer
    ABIOMED, INC.
    Product Code
    OJE
    UDI-DI
    00813502010022
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS INVOLVED IN THIS EVENT WERE DISCARDED BY THE USER. A REVIEW OF THE CLINICAL CASE REVEALED THE IMPLANTING PHYSICIAN REPORTED THE PATIENT'S HEART WAS IN VERY POOR CONDITION AND WAS "FALLING APART...LIKE PAPER TEARING." AFTER THE PATIENT'S HEART WAS REPAIRED THE RIGHT HEART BEGAN PUMPING AGAIN AND THE PATIENT WAS STABLE. AN ABIOMED PHYSICIAN ALSO REVIEWED THE CASE AND BELIEVES THE PERFORATION WAS DUE TO THE CONTINUED MANIPULATION OF THE GUIDEWIRES AND GUIDING CATHETERS. THE ROOT CAUSE OF THE RIGHT HEART PERFORATIONS DURING MANIPULATION OF THE VARIOUS GUIDEWIRES AND CATHETERS WAS MOST LIKELY DUE TO THE PATIENT'S FRIABLE CARDIAC TISSUE. 17-0985.

    Description of Event or Problem · 1

    AN IMPELLA RP WAS IMPLANTED INTO A (B)(6) FEMALE PATIENT FOR SUPPORT FOR AN OFF-PUMP CORONARY ARTERY BYPASS. THE PATIENT PRESENTED WITH AN EJECTION FRACTION RANGE OF 35-40%, WITH A FRIABLE (THIN AND WEAK) RIGHT ATRIUM. AFTER THE BYPASS, THE CLINICAL TEAM WAS UNABLE TO FLOAT THE SWAN TO THE LEFT PULMONARY ARTERY USING A PIGTAIL CATHETER, THEFORE THE CATHETER WAS EXCHANGED FOR A MULTIPURPOSE CATHETER. THE MULTIPURPOSE CATHETER WAS REMOVED AND THE IMPELLA RP WAS INSERTED. INSERTION OF THE IMPELLA RP WAS DIFFICULT AND THE PHYSICIAN NOTED THE GUIDE WIRE WAS DIFFICULT TO ADVANCE, AND HE WAS UNSURE WHETHER THE GUIDE WIRE WAS IN THE RIGHT PLACE. THE IMPELLA RP WAS UNABLE TO ADVANCE INTO THE LEFT PULMONARY ARTERY DESPITE SEVERAL ATTEMPTS. DURING THESE ATTEMPTS THE PATIENT WENT INTO ATRIAL FIBRILLATION, AND THE PATIENT'S RIGHT ATRIUM AND RIGHT VENTRICAL WERE PERFORATED. THE RIGHT HEART WAS REPAIRED WITH SUTURES AND BEGAN TO PUMP AGAIN. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND THERE WAS NO INDICATION OF FURTHER ADVERSE EFFECT TO THE PATIENT FOLLOWING THE SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786838 IMPELLA RP RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE OJE ABIOMED, INC. IMPELLA RP 1276209 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention