BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA LP2.5 AIC PUMP SET, US

    MDR report key: 6726330 · Received July 19, 2017

    Report

    Report Number
    1220648-2017-00055
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    October 20, 2016
    Report Date
    June 29, 2017
    Manufacturer
    ABIOMED EUROPE GMBH
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ADVERSE EVENT WAS NOT REPORTED TO ABIOMED, INC. AT THE TIME IT OCCURRED. THE IMPELLA 2.5 PUMP WAS NOT RETURNED FOR EVALUATION, AS IT WAS DISCARDED SUBSEQUENT TO PATIENT USE; CONSEQUENTLY, NO DEVICE ANALYSIS COULD BE PERFORMED AND THE ROOT CAUSE OF THE TISSUE TEAR IN THE NON-CORONARY CUSP OF THE AV WAS UNABLE TO BE DETERMINED. THE MANUFACTURER WILL CONTINUE TO MONITOR AND INVESTIGATE ALL REASONABLE AND OBTAINABLE SOURCES OF INFORMATION AND WILL PROVIDE RESULTS AND CONCLUSIONS IN A SUPPLEMENT MEDWATCH REPORT, IF ANY ADDITIONAL INFORMATION IS RECEIVED. NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME BECAUSE THE FAILURE IS DETERMINED TO BE LOW RISK. THE FAILURE WILL CONTINUE TO BE MONITORED AND TRACKED. (B)(4).

    Description of Event or Problem · 1

    ON JUNE 26, 2017 DURING THE (B)(6) A POSTER WAS EXHIBITED THAT REPORTED AN ADVERSE EVENT THAT HAD OCCURRED WITH AN IMPELLA LP2.5 PUMP ON (B)(6) 2016. ALTHOUGH PATIENT SUPPORT WITH THE DEVICE HAD BEEN DOCUMENTED, THE ADVERSE EVENT HAD NEVER PREVIOUSLY BEEN REPORTED TO ABIOMED. THE FOLLOWING IS THE REPORT THAT WAS DISPLAYED ON THE POSTER AND SEEN AT THE ASIO CONFERENCE: A (B)(6) FEMALE PRESENTED WITH CRITICAL CARDIOGENIC SHOCK AND CARDIAC ARREST AFTER A RECENT ILLNESS FROM VIRAL CARDIOMYOPATHY. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TTE) DEMONSTRATED AN EJECTION FRACTION (EF) OF 20-25% WITH SEVERE GLOBAL HYPO-KINESIS AND DILATION. A FEMORAL VA-ECLS WAS INITIATED AND THE IMPELLA 2.5 PLACED VIA THE LEFT FEMORAL ARTERY. THE IMPELLA REQUIRED REPOSITIONING 3 TIMES WITH TTE GUIDANCE. THE IMPELLA WAS TURNED DOWN TO P0 PRIOR TO MANIPULATION. A POD 15, DURABLE CENTRIFUGAL FLOW LVAD WAS IMPLANTED AND THE IMPELLA WAS WITHDRAWN. FOLLOWING LVAD INITIATION, AN INTRAOPERATIVE TEE REVEALED NEW MODERATE-SEVERE AORTIC INSUFFICIENCY (AI) AND SHOWED A FLOATING OBJECT IN THE NON-CORONARY CUSP OF THE AORTIC VALVE (AV). THE PATIENT'S HEART ARRESTED AND UPON VISUAL INSPECTION, A TISSUE TEAR WAS NOTED IN THE NON-CORONARY CUSP OF AV. AV REPAIR WAS PERFORMED. TEE SHOWED TRACE TO MILD AI AFTER THE LEAFLET REPAIR. PATIENT RECOVERED AND WAS DISCHARGED WITH LVAD 57 DAYS AFTER PRESENTATION. THE PATIENT USE OF THIS DEVICE WAS REPORTED TO ABIOMED ON OCTOBER 5, 2016, WITH UPDATES THROUGH OCTOBER 20, 2017. THERE WERE NO INDICATIONS FROM THE HOSPITAL STAFF, AT ANYTIME DURING OR AFTER PATIENT SUPPORT, TO AN ABIOMED EMPLOYEE OF THE ABOVE DETAILED ISSUE; CONSEQUENTLY, THE ISSUE WAS NOT REPORTED IN OUR STANDARD CASE REPORT. THE LAST INFORMATION RECEIVED BY ABIOMED (PRIOR TO OBSERVING THE POSTER AT THE (B)(6) CONFERENCE ON JUNE 29, 2017) WAS ON OCTOBER 20, 2016, AT WHICH TIME THE FOLLOWING WAS ENTRY WAS ADDED TO OUR STANDARD REPORT: 10/20 PM UPDATE: SPOKE WITH RN- IMPELLA EXPLANTED TODAY. PATIENT DOING OK. PATIENT IS ON HEARTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505852 IMPELLA LP2.5 AIC PUMP SET, US PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE, OZD ABIOMED EUROPE GMBH IMPELLA LP2.5 1248774

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention