BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? ELEMENT?

    MDR report key: 3083105 · Received April 29, 2013

    Report

    Report Number
    2134265-2013-02789
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE HYPOTUBE. THE BREAK WAS LOCATED AT 21.2CM DISTAL TO THE STRAIN RELIEF. BOTH SECTIONS OF THE HYPOTUBE BREAK WERE KINKED AT VARIOUS LOCATIONS. AN EXAMINATION OF THE CRIMPED STENT IDENTIFIED NO ANOMALIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING, STENT DAMAGE WAS NOTED. THE STENT OF A 3.0MM X 20MM TAXUS ELEMENT STENT WAS NOTED TO BE DAMAGED DURING REMOVED FROM ITS PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATEINT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING, STENT DAMAGE WAS NOTED. THE STENT OF A 3.0MM X 20MM TAXUS ELEMENT STENT WAS NOTED TO BE DAMAGED DURING REMOVED FROM ITS PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184442 TAXUS? ELEMENT? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902520300 15012673

    Patients

    Seq Age Sex Outcome Treatment
    1