BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM

    MDR report key: 1012969 · Received March 13, 2008

    Report

    Report Number
    2134265-2008-00752
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 16, 2008
    Report Date
    February 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2008-00753. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THROMBOSIS OCCURRED. THE INITIAL PROCEDURE OCCURRED IN MARCH 2005. THE PATIENT PRESENTED WITH CHEST PAIN AND ELEVATED TROPONIN LEVELS. CARDIAC CATHETERIZATION REVEALED A 95% STENOSIS IN THE DISTAL OBTUSE MARGINAL (OM), AN 80% STENOSED OSTIAL LESION IN THE OM AND A 60% STENOSIS IN THE POSTERIOR DESCENDING ARTERY (PDA). THE DISTAL OM WAS PRE-DILATED, UNKNOWN TYPE AND SIZE BALLOON, FOLLOWED BY THE PLACEMENT OF A NON BSC 3.0X13MM STENT WITH GOOD ANGIOGRAPHIC RESULTS. A RESIDUAL STENOSIS REMAINED IN THE MORE DISTAL OM, WHICH THE PHYSICIAN THEN BALLOONED WITH THE 3.0X13MM STENT BALLOON, WITH HIGH PRESSURE AND GOOD ANGIOGRAPHIC RESULTS. THE BIFURCATION OF THE CX WAS THEN STENTED USING THE "CRUSHED STENT TECHNIQUE." A TAXUS EXPRESS2 3.0X16MM DRUG ELUTING STENT WAS POSITIONED IN THE OSTIUM OF THE OM AND A TAXUS EXPRESS2 3.0X32MM DRUG ELUTING STENT WAS POSITIONED IN THE CX PROPER. THE OM STENT WAS DEPLOYED FIRST AND POST DILATED WITH 3.0X8MM QUANTUM BALLOON. THE TAXUS STENT IN THE CX WAS THEN INFLATED AND DEPLOYED AT 10 ATMS. THE FINAL RESULT WAS GOOD. AN ATTEMPT WAS MADE TO POST DILATE THE SLIGHTLY STENOTIC OSTIUM, BUT THE PHYSICIAN WAS UNABLE TO ADVANCE THE BALLOON INTO THE VESSEL, ANGIOMAX AND PLAVIX WERE ADMINISTERED DURING THIS PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. IN 2008, THE PATIENT PRESENTED WITH CHEST PAIN AND CARDIAC CATHETERIZATION REVEALED THE 2 PREVIOUSLY PLACED TAXUS STENTS WERE COMPLETELY OCCLUDED. BOTH STENTS WERE BALLOONED USING AN UNKNOWN SIZE MAVERICK BALLOON WITH GOOD RESULTS. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS POST PROCEDURE IS NOTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 3.0X32MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CYPHER