BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 763436 · Received September 20, 2006

    Report

    Report Number
    6000093-2006-01889
    Event Type
    Injury
    Date Received
    September 20, 2006
    Date of Event
    August 18, 2006
    Report Date
    August 21, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    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 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 MFG RECORDS FOR TOP ASSEMBLY BATCH 8182594 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 INFO BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    TAP. IT WAS REPORTED THAT 182 DAYS AFTER IMPLANTATION OF A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE 1ST DIAGONAL ARTERY. A PRE-INTERVENTION STENOSIS PERCENTAGE WAS NOT REPORTED. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED USING A 2.0X15MM OVER THE WIRE (OTW) MAVERICK BALLOON. A 2.5X24MM TAXUS STENT WAS DEPLOYED IN THE 1ST DIAGONAL ARTERY IN THE REGION OF THE LESION. A POST-INTERVENTION RESIDUAL STENOSIS PERCENTAGE WAS NOT REPORTED. THE PT RECEIVED ANGIOMAX DURING THE PROCEDURE. COMPLICATIONS WERE REPORTED AS "NONE". THE PT PRESENTED 182 DAYS AFTER THE INITIAL PROCEDURE WITH CHEST PAIN AND IN-STENT RESTENOSIS IN THE 1ST DIAGONAL ARTERY. PTCA WAS PERFORMED USING A 2.0X20MM OTW MAVERICK BALLOON. SUBSEQUENTLY, A 2.75X33 MM CYPHER DRUG ELUTING STENT WAS DEPLOYED IN THE 1ST DIAGONAL ARTERY IN THE REGION OF THE LESION. A POST-INTERVENTION RESIDUAL STENOSIS WAS NOT REPORTED. THE PT RECEIVED ANGIOMAX DURING THE PROCEDURE. COMPLICATIONS WERE REPORTED AS "NONE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.5X24MM 8182594

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R