BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 770130 · Received October 13, 2006

    Report

    Report Number
    6000093-2006-02076
    Event Type
    Injury
    Date Received
    October 13, 2006
    Date of Event
    September 12, 2006
    Report Date
    September 15, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED AND THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. BECAUSE THE BATCH NUMBER FOR THE STENT INVOLVED IN THIS COMPLAINT IS NOT KNOWN, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MANUFACTURER'S REPORT #6000093-2006-02074, #6000963-2006-02073, #6000093-2006-02075. TAP. IT WAS REPORTED THAT 96 DAYS AFTER IMPLANTATION OF 2.5X24MM , 2.75X32MM, 2.5X16MM, AND 2.5X12MM TAXUS EXPRESS2 DRUG ELUTING STENT, IN-STENT RESTENOSES OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESIONS WERE LOCATED IN THE LEFT CIRCUMFLEX ARTERY (LCX), LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE 2ND DIAGONAL BRANCH ARTERY. A PRE-INTERVENTION STENOSIS OF 99%, 70-99%, RESPECTIVELY, WAS REPORTED. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED USING A KISSING BALLOON TECHNIQUE ON THE LCX AND LAD ARTERIES. PTCA WAS ALSO PERFORMED ON THE 2ND DIAGONAL BRANCH AND LAD ARTERIES USING A KISSING BALLOON TECHNIQUE. A 2.5X24MM TAXUS STENT WAS DEPLOYED IN THE LCX IN THE REGION OF THE LESION. IN THE LAD, 2.75X32MM AND 2.5X16MM TAXUS STENTS WERE DEPLOYED IN THE REGION OF THE LESIONS. A 2.5X12MM TAXUS STENT WAS DEPLOYED IN THE 2ND DIAGONAL BRANCH ARTERY IN THE REGION OF THE LESION. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED FOR THE LCX, LAD, AND 2ND DIAGONAL BRANCH ARTERY. IT WAS REPORTED THAT THE PATIENT "TOLERATED THE PROCEDURE WELL'". THE PATIENT PRESENTED 96 DAYS AFTER THE INITIAL PROCEDURE WITH AN 80% IN-STENT RESTENOSIS IN THE LCX, AND 90% IN-STENT RESTENOSIS IN THE OSTIAL LAD AND 2ND DIAGONAL BRANCH ARTERY. PTCA WAS PERFORMED ON THE LCX FOLLOWED BY THE DEPLOYMENT OF A 3.0X12MM TAXUS STENT. THE LAD WAS NOTED TO HAVE AN OSTIAL 90% IN-STENT RESTENOSIS AND A PROXIMAL 70% STENOSIS. PTCA WAS PERFORMED ON THE LAD AND A 3.0X32MM TAXUS STENT WAS DEPLOYED AT 18 ATM IN THE REGION OF THE LESION. THE 2ND DIAGONAL BRANCH ARTERY WAS NOTED TO HAVE "MULTIPLE" SITES OF IN-STENT RESTENOSIS. PTCA WAS PERFORMED ON THE 2ND DIAGONAL BRANCH ARTERY WITH A 2.0MM NONCOMPLIANT BALLOON. A KISSING BALLOON TECHNIQUE WAS USED ON THE LAD AND 2ND DIAGONAL BRACH ARTERY LESIONS. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED FOR THE LCX, LAD, AND 2ND DIAGONAL BRANCH ARTERY. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE "WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.5X16MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R