BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3971079 · Received July 31, 2014

    Report

    Report Number
    2134265-2014-04350
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CURRENT AGE: (B)(6). EVENT DATE" (B)(6) 2005. IT IS UNKNOWN WHICH TWO OF THE THREE IMPLANTED DEVICES WERE COLLAPSED. THE UPN AND BATCH INFORMATION OF THE THREE DEVICES ARE AS FOLLOWS: H7493897012250 - TAXUS EXP2 - 8.8PCT (MRUS) - 2.50X12MM - 38970-1225 LOT: 7112263. H7493897032300 - TAXUS EXP2 - 8.8PCT (MRUS) - 3.00X32MM - 38970-3230 LOT: 7007554. H7493897032350 - TAXUS EXP2 - 8.8PCT (MRUS) - 3.50X32MM - 38970-3235 LOT: 7073281. DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED; THEREFORE, ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE IMPLANTED STENT COLLAPSED. IN (B)(6) 2005, THREE STENTS WERE IMPLANTED, A 2.5X12MM TAXUS EXPRESS 2, 3.0X32MM TAXUS EXPRESS 2 AND A 3.5X32MM TAXUS EXPRESS 2. TWO WEEKS FOLLOWING THE INITIAL PROCEDURE THE PATIENT COLLAPSED AND WAS TAKEN TO THE HOSPITAL VIA AMBULANCE. PATIENT WAS LATER TRANSFERRED TO ANOTHER HOSPITAL AND UNDERWENT SURGERY. THE SURGEON NOTED THAT TWO OF THE THREE IMPLANTED TAXUS EXPRESS 2 STENTS WERE COLLAPSED. TWO ADDITIONAL STENTS WERE IMPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447552 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention