BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT-SHILEY AORTIC ROOT CANNULAE

    MDR report key: 7572882 · Received June 6, 2018

    Report

    Report Number
    9680841-2018-00014
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 7, 2018
    Report Date
    July 25, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DWF
    UDI-DI
    08033178004022
    PMA / PMN Number
    K861310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF THE EVENT. (B)(4). SORIN GROUP (B)(4) MANUFACTURES THE STOCKERT-SHILEY AORTIC ROOT CANNULAE. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT YET RETURNED.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE STOCKERT-SHILEY AORTIC ROOT CANNULAE. THE INCIDENT OCCURRED IN SASSARI, ITALY. PER EXEMPTION NUMBER E2016005, SORIN GROUP ITALIA S.R.L. IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP ITALIA S.R.L (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). THE INVOLVED CANNULA WAS REQUESTED FOR RETURN TO SORIN GROUP ITALIA, HOWEVER THE DEVICE HAS NOT BEEN PROVIDED FOR INVESTIGATION. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, PHOTOGRAPHIC WERE PROVIDED WHICH ENABLED SORIN GROUP ITALIA TO VERIFY THAT THE LARGER RING WAS BROKEN ALONG ITS LONGITUDINAL AXIS. NO OTHER COMPLAINT HAS BEEN RECEIVED FOR THE REPORTED LOT OF CANNULA. REVIEW OF THE SORIN GROUP ITALIA COMPLAINT DATABASE SHOWED THAT THE REPORTED FAILURE HAS A VERY LOW FREQUENCY OF OCCURRENCE. BASED ON THIS, AND BECAUSE THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, NO CORRECTIVE ACTIONS WERE IDENTIFIED. SORIN GROUP ITALIA WILL CONTINUE TO MONITOR THE MARKET FOR SIMILAR CASES.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT AT THE BEGINNING OF A PROCEDURE, A PLASTIC PART OF THE AORTIC NEEDLE BROKE INTO TWO PIECES. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418809 STOCKERT-SHILEY AORTIC ROOT CANNULAE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SORIN GROUP ITALIA S.R.L. R502-26 1611180024 08033178004022

    Patients

    Seq Age Sex Outcome Treatment
    1