BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1891338 · Received November 4, 2010

    Report

    Report Number
    2134265-2010-05029
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - RETURNED PRODUCT CONSISTED OF A MR TAXUS ELEMENT STENT DELIVERY SYSTEM (SDS) WITH NO CARRIER TUBE, PRODUCT MANDREL OR BALLOON PROTECTOR. NO BLOOD AND CONTRAST WERE VISIBLE IN THE DISTAL AND MIDSHAFT OF THE DEVICE WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS NOT USED. THE RETURNED CATHETER WAS VISUALLY AND TACTILELY EXAMINED ALONG THE ENTIRE LENGTH OF SHAFT AND IT WAS DETERMINED THAT THE DISTAL OUTER SHAFT AND THE INNER SHAFT HAD MULTIPLE KINKS AND WAS STRETCHED/BUCKLED FROM 118CM TO 128CM FROM THE STRAIN RELIEF. THE DISTAL END OF THE SDS WAS INSPECTED UNDER MAGNIFICATION AND FOUND NO STENT OR TIP DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PATIENT PRESENTED WITH ANGINA PECTORIS. THE LESION WAS LOCATED IN AN UNSPECIFIED CORONARY ARTERY. AS THE PHYSICIAN WAS REMOVING THE 2.5X20MM TAXUS ELEMENT STENT FROM THE PACKAGING WEAK RESISTANCE WAS NOTED. WHEN THE DEVICE WAS EXAMINED THE STENT WAS SEEN TO BE PULLED APART AND STICKING INTO THE PROTECTIVE SHEATH. THE DEVICE WAS NEVER IN CONTACT WITH THE PATIENT; THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS STABLE. THIS PRODUCT IS ONLY (B)(4) APPROVED, BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PATIENT PRESENTED WITH ANGINA PECTORIS. THE LESION WAS LOCATED IN AN UNSPECIFIED CORONARY ARTERY. AS THE PHYSICIAN WAS REMOVING THE 2.5X20MM TAXUS ELEMENT STENT FROM THE PACKAGING WEAK RESISTANCE WAS NOTED. WHEN THE DEVICE WAS EXAMINED THE STENT WAS SEEN TO BE PULLED APART AND STICKING INTO THE PROTECTIVE SHEATH. THE DEVICE WAS NEVER IN CONTACT WITH THE PATIENT; THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS STABLE. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902520250 0012938733

    Patients

    Seq Age Sex Outcome Treatment
    1