BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSFORM SUPER COMPLIANT 3MM X 5MM

    MDR report key: 4912514 · Received July 14, 2015

    Report

    Report Number
    3008853977-2015-00294
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 1, 2015
    Manufacturer
    STRYKER NEUROVASCULAR CORK (MDR)
    Product Code
    MJN
    PMA / PMN Number
    K122576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS DISPOSED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT REPORTED. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, THROMBUS IS A KNOWN RISK ASSOCIATED WITH SUCH PROCEDURES AND NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE AFTER THE BALLOON WAS ADVANCED INTO THE A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA), THROMBUS WAS NOTED IN THE ACA A2 SEGMENT. INTEGRILIN (EXACT DOSAGE UNKNOWN) WAS ADMINISTERED AND PATENCY TO THE VESSEL WAS RESTORED. THE PROCEDURE WAS COMPLETED. THE PATIENT EXPERIENCED CONFUSION UPON WAKING UP POST PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE AFTER THE BALLOON WAS ADVANCED INTO THE A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA), THROMBUS WAS NOTED IN THE ACA A2 SEGMENT. INTEGRILIN (EXACT DOSAGE UNKNOWN) WAS ADMINISTERED AND PATENCY TO THE VESSEL WAS RESTORED. THE PROCEDURE WAS COMPLETED. THE PATIENT EXPERIENCED CONFUSION UPON WAKING UP POST PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457365 TRANSFORM SUPER COMPLIANT 3MM X 5MM CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN STRYKER NEUROVASCULAR CORK (MDR) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R