BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1941458 · Received December 29, 2010

    Report

    Report Number
    2134265-2010-05760
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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 A STENTING TREATMENT PROCEDURE, A STENT DISLODGED FROM THE STENT DELIVERY SYSTEM. ANGIOGRAPHY REVEALED DIFFUSE AND CALCIFIED LESIONS LOCATED IN LEFT ANTERIOR DESCENDING (LAD) ARTERY, LEFT CIRCUMFLEX (LCX) ARTERY AND THE RIGHT CORONARY ARTERY. THE INDEX PROCEDURE TREATED TWO LESIONS. THE FIRST LESION WAS A 2.5X18MM, 90% STENOSED LESION LOCATED IN THE MODERATELY CALCIFIED, MILDLY TORTUOUS PROXIMAL TO MID LAD. PRE-DILATION USED TWO ROTALINK BURRS (1.5MM, 1.75MM) AND A NON BSC 2.5X15MM BALLOON INFLATED TWICE TO 14 ATM'S FOR 8 SECONDS REDUCING STENOSIS TO 70%. A 2.5X24MM TAXUS LIBERTE STENT WAS SUCCESSFULLY PLACED IN THE MID LAD. NEXT THE PHYSICIAN WAS GOING TO IMPLANT A 2.75X32MM TAXUS LIBERTE STENT MORE PROXIMALLY BUT IT WAS DIFFICULT FOR THE STENT TO CROSS THE LESION AND THE STENT CAME OFF THE STENT DELIVERY SYSTEM PRIOR TO DEPLOYMENT. THE PHYSICIAN CONTINUED AND SUCCESSFULLY IMPLANTED TWO ADDITIONAL TAXUS LIBERTE STENTS (2.75X32MM, 3.0X16MM) IN THE PROXIMAL TO MIDDLE PORTION OF THE LAD ARTERY. THE DISLODGED STENT WAS LOCATED AND SUCCESSFULLY SNARED FROM THE LEFT ILIAC ARTERY. THE SECOND LESION WAS A 90% STENOSED BIFURCATED LESION LOCATED IN THE OSTIUM OF THE LEFT CIRCUMFLEX ARTERY AND OBTUSE MARGINAL BRANCH. TREATMENT USED FOUR INFLATIONS WITH A 2.5X15MM NON BSC BALLOON TO 16 ATM'S FOR 7 SECONDS TO PRE-DILATE THE LESION. THE PHYSICIAN ADVANCED A 2.5X20MM TAXUS LIBERTE STENT TO COVER THE LESION, BUT THE STENT COULD NOT CROSS THE LESION. A 2.5X18MM NON BSC STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OK.

    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 H7493894032270 0013516163

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention BMW 190CM 0.014 INCH GUIDE WIRE| LAUNCHER 7FR EBU 3.5 GUIDE CATHETER