BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1790560 · Received August 10, 2010

    Report

    Report Number
    2134265-2010-03476
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - A VISUAL EXAMINATION IDENTIFIED A HYPOTUBE BREAK 13.6CM FROM THE CATHETER STRAIN RELIEF. THERE WERE ALSO KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS USER ERROR. THE DFU STATES THAT TAXUS LIBERTE SHOULD ONLY BE USED IN NATIVE CORONARY ARTERIES AND IN THIS CASE THE DEVICE WAS USED IN THE LEFT ANTERIOR TIBIAL ARTERY. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - 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)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE 100% TOTALLY OCCLUDED LESION WAS LOCATED IN THE LEFT ANTERIOR TIBIAL ARTERY. A 3.0X38MM TAXUS LIBERTE' LONG STENT WAS ADVANCED TO THE LESION AND BROKE MID SHAFT WHILE TRYING TO CROSS THE LESION. THE DEVICE WAS REMOVED WITHOUT ANY ISSUE. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS LISTED AS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE 100% TOTALLY OCCLUDED LESION WAS LOCATED IN THE LEFT ANTERIOR TIBIAL ARTERY. A 3.0X38MM TAXUS LIBERTE LONG STENT WAS ADVANCED TO THE LESION AND BROKE MID SHAFT WHILE TRYING TO CROSS THE LESION. THE DEVICE WAS REMOVED WITHOUT ANY ISSUE. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893638300 12828472

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR PT2 MS 300CM GUIDE WIRE| 7FR COOK TOUHY FLEXOR SHUTTLE SHEATH CATHETER