BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STE

    MDR report key: 2304451 · Received March 11, 2006

    Report

    Report Number
    6000093-2006-02719
    Event Type
    Injury
    Date Received
    March 11, 2006
    Date of Event
    February 7, 2006
    Report Date
    February 9, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE 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. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 7221955 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    SAME CASE AS MANUFACTURER'S REPORT #6000093-2006-00388 (B)(6), 6000093-2006-XXXXX (B)(6), AND 6000093-2006-XXXXX (B)(6). (B)(6). IT WAS REPORTED THAT 213 DAYS AFTER IMPLANTATION OF SEVERAL TAXUS EXPRESS2 DRUG ELUTING STENTS, IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, A 90% STENOTIC LESION IN THE RAMUS ARTERY WAS TREATED WITH A 2.5 X 12 MM TAXUS AND KISSING BALLOON ANGIOPLASTY. A 90-95% STENOTIC, LONG LESION IN THE LEFT CIRCUMFLEX (LCX) CORONARY ARTERY WAS TREATED WITH A 3.0X32 MM TAXUS STENT. A 96% STENOTIC LESION IN THE 1ST OBTUSE MARGINAL (OM1) CORONARY ARTERY WAS TREATED WITH A 2.5X20 MM TAXUS STENT. FINALLY, A 20-9% STENOTIC LESION IN THE 2ND OBTUSE MARGINAL (OM2) CORONARY ARTERY WAS TREATED WITH A 2.5X20 MM TAXUS STENT AND KISSING BALLOON ANGIOPLASTY. A POST-INTERVENTION STENOSIS OF 0% WAS REPORTED FOR ALL LESIONS. NO INFORMATION WAS RECEIVED REGARDING THE VESSEL TORTUOUSITY OR CALCIFICATION. NO INFORMATION WAS REPORTED CONCERNING PATIENT MEDICATIONS. THE PATIENT WAS REPORTED HAVING TOLERATED THE PROCEDURE WELL. THE PATIENT PRESENTED 213 DAYS AFTER THE INITIAL PROCEDURE WITH A 90% IN-STENT RESTENOSIS OF THE RAMUS, 70-90% RESTENOSIS OF THE PROXIMAL TO MID LCX, AND 90% RESTENOSIS OF THE OM1 AND OM2 TAXUS STENTS. THE LCX RESTENOSIS WAS TREATED WITH PTCA AND A 2.5X20 TAXUS STENT. ALL LESIONS WERE REPORTED TO HAVE 0% STENOSIS FOLLOWING RE-INTERVENTION. NO INFORMATION WAS REPORTED CONCERNING PATIENT MEDICATIONS. THE PATIENT WAS REPORTED HAVING TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STE DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 00X32 7627301

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention