BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 776710 · Received August 1, 2006

    Report

    Report Number
    6000093-2006-01404
    Event Type
    Injury
    Date Received
    August 1, 2006
    Date of Event
    July 10, 2006
    Report Date
    July 11, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH #7232348 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORD'S REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. SHOULD FURTHER RELEVANT INFO BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    TAP - IT WAS REPORTED THAT 327 DAYS AFTER A CORONARY DRUG ELUTING STENTING PROCEDURE, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A PRE-INTERVENTION STENOSIS OF 60-75% WAS REPORTED. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED ON THE MID AND PROXIMAL LAD WITH A 2.5MM BALLOON. A 2.75X16 MM TAXUS STENT WAS DEPLOYED IN THE MID LAD. THE STENT WAS POST-DILATED WITH A 3.0MM BALLOON. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. IT WAS REPORTED THAT "A NICE RESULT WAS ACHIEVED." NO COMPLICATIONS WERE REPORTED. THE PT PRESENTED 327 DAYS AFTER THE INITIAL PROCEDURE WITH 67-77% IN-STENT RESTENOSIS IN THE MID AND "NEAR-OSTIAL" LAD. INTRAVASCULAR ULTRASOUND WAS USED TO CONFIRM IN-STENT RESTENOSIS AND STENOSIS IN THE NATIVE LAD VESSEL. IT WAS REPORTED THAT THREE "DRUG ELUTING" STENTS WERE PLACED DISTAL TO PROXIMAL. A 2.75 STENT WAS PLACED DISTALLY AND A 3.5MM "OSTIALLY." THE TYPE AND LENGTH OF STENT, AND INFO CONCERNING THE THIRD STENT WAS NOT REPORTED. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. NO COMPLICATIONS WERE REPORTED. IT IS NOTED THAT THE DEVICE WAS USED BEYOND ITS EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.75X16MM 7232348

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other| R