BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STE

    MDR report key: 2923277 · Received April 26, 2006

    Report

    Report Number
    6000089-2006-02663
    Event Type
    Injury
    Date Received
    April 26, 2006
    Date of Event
    March 23, 2006
    Report Date
    March 27, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH (B)(4) HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    TAP - IT WAS REPORTED THAT 77 DAYS AFTER IMPLANTATION OF A 2.75X32 MM TAXUS EXPRESS2 DRUG ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS DESCRIBED AS "SUBTOTALLY OCCLUDED." NO INFORMATION WAS REPORTED CONCERNING VESSEL CALCIFICATION OR TORTUOSITY. AFTER BALLOON DILATION, THE PHYSICIAN WAS UNABLE TO ACCESS THE RCA WITH THE INITIAL 2.75X32 MM TAXUS STENT. SUBSEQUENTLY, A REPLACEMENT 300 J TIP GUIDE WIRE WAS USED TO CROSS THE LESION AND 2.75X32MM TAXUS STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. POST-INTERVENTION RESULTS WERE DESCRIBED AS "EXCELLENT ANGIOGRAPHIC RESULTS" WITH "NORMAL FLOW." THE PATIENT RECEIVED BIVALIRUDIN AND INTRACORONARY NITROGLYCERIN DURING PROCEDURE. THE PATIENT EXPERIENCED NO COMPLICATIONS DURING THE PROCEDURE AND REMAINED IN STABLE CONDITION. THE PATIENT PRESENTED 77 DAYS AFTER THE INITIAL PROCEDURE WITH A 99% IN-STENT RESTENOSIS IN THE MID RCA AND AN INFERIOR WALL MYOCARDIAL INFARCTION. AFTER BALLOON DILATION, A 3.0X33 MM CORDIS CYPHER WAS DEPLOYED IN THE RESTENOSED REGION. A POST-INTERVENTIONAL RESULT OF "0% STENOSIS" WAS REPORTED. THE PROCEDURE WAS PERFORMED "WITHOUT COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STE DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.75X32MM 7762229

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention