BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2212290 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03635
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). DATE OF BIRTH: (B)(6). 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

    (B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTIES AND STENT DAMAGE OCCURRED. THE 10MM LONG TARGET LESION WAS LOCATED IN THE CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH A REFERENCE VESSEL DIAMETER OF 3.75MM. A SECOND LESION WAS NOTED IN THE MID LAD AND WAS 80% STENOSED AND 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.75MM. A 3.5X38MM TAXUS ELEMENT STENT DELIVERY SYSTEM WAS ADVANCED FOR DIRECT STENTING, HOWEVER IT WAS UNABLE TO CROSS THE LESION. A 3.5X15MM NON-BSC SCORING BALLOON WAS THEN ADVANCED, BUT IT ALSO COULD NOT CROSS THE LESION. PREDILATION THEN WAS PERFORMED WITH A 3.0X15MM NON-BSC BALLOON AND THEN WITH THE 3.5X15MM NON-BSC SCORING BALLOON. THE 3.5X38MM TAXUS ELEMENT STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE ADVANCED AGAIN, HOWEVER IT COULD NOT CROSS THE LESION. WHILE ATTEMPTING TO RETRIEVE THE DEVICE, THE PROXIMAL EDGE OF THE STENT HIT THE VESSEL, "POSSIBLY A CALCIUM DEPOSIT" AND THE PROXIMAL PORTION OF THE STENT IMPACTED ON ITSELF AND THE BALLOON WAS PARTIALLY RETRIEVED. IT WAS NOT POSSIBLE TO EITHER ADVANCE OR RETRIEVE THE STENT, SO IT WAS DEPLOYED AT ITS CURRENT LOCATION. POST DILATION WAS PERFORMED WITH A NON-COMPLIANT BALLOON AT THE DAMAGED PROXIMAL PORTION OF THE STENT. A 3.0X12MM TAXUS ELEMENT STENT WAS DEPLOYED TO COVER THE LESION AND OVERLAP THE PREVIOUSLY PLACED STENT. NO PATIENT INJURY WAS OBSERVED AND IT WAS NOTED THAT THERE WAS "GOOD FINAL RESULT".

    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 - GALWAY H7493902538350 0013573178

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention