BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1210710 · Received October 23, 2008

    Report

    Report Number
    2134265-2008-03111
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 29, 2006
    Report Date
    September 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2008-02626, 2134265-2008-02625, 2134265-2008-03110, 2134265-2008-03112 AND 2134265-2008-03109. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, RESTENOSIS AND A THROMBOSIS OCCURRED. IT WAS FURTHER REPORTED THAT FIVE TAXUS EXPRESS2 DRUG ELUTING STENTS WERE PLACED. ANGIOPLASTY WAS PERFORMED TO THE SECOND OBTUSE MARGINAL (OM), THE PROXIMAL CIRCUMFLEX (CX) AND BETWEEN THE FIRST AND SECOND OM. ANGIOPLASTY WAS ALSO PERFORMED TO THE TAKE-OFF OF THE CX AT THE JUNCTURE OF THE SECOND OM. THESE WERE PERFORMED WITH MAVERICK 3.0X20MM AND 3.5X12MM BALLOONS. THE SECOND OM WAS STENTED WITH A 3.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT. THE CX WAS STENTED WITH A TAXUS 3.5X8MM STENT. THE JUNCTION OF THE SECOND OM AND THE CX WAS STENTED WITH A TAXUS 3.5X12MM STENT. THE CX AND FIRST OM TAKE-OFF WAS STENTED WITH A TAXUS 3.5X12MM TAXUS STENT. THE PROXIMAL CX AND SECOND OM WAS STENTED WITH A TAXUS 3.5X12MM TAXUS STENT. THESE STENTS WERE ALL PLACED TO RECONSTRUCT THE CX AND SECOND OM BIFURCATING AREA. TIMI III FLOW WAS ACHIEVED, BUT A RESIDUAL STENOSIS OF 20-30% REMAINED. FENTANYL, TRIDIL, NITROGLYCERIN, ANGIOMAX AND PLAVIX WERE ADMINISTERED. SEVENTEEN DAYS POST PROCEDURE, THE RIGHT CORONARY ARTERY WAS ELECTIVELY TREATED. A MAVERICK 2.0X20MM BALLOON WAS USED FOR PRE-DILATATION FOLLOWED BY THE PLACEMENT OF THREE TAXUS EXPRESS2 DRUG ELUTING STENTS TO THE DISTAL TWO-THIRDS OF THE RCA. A 3.0X16MM, A 2.75X32MM AND A3.0X12MM WERE ALL PLACED IN AN OVERLAPPING FASHION, AND WERE POST DILATED WITH A 3.0X16MM BALLOON TO 16 ATMS WITH EXCELLENT RESULTS. THE PHYSICIAN ALSO EVALUATED THE CX AND THE SECOND OM AT THIS TIME AND FOUND THERE TO BE A 99% STENOSIS AT THE JUNCTION OF THE CX AND THE SECOND OM WITH TIMI I FLOW. THERE WAS ALSO A 70% STENOSIS IN THE PROXIMAL LIMB OF THE SECOND OM. THE CX PROPER WAS BALLOONED REPEATEDLY WITH 3.5MM BALLOONS, BUT A RESIDUAL STENOSIS OF 40% REMAINED. THIS WAS NOT TREATED AS THE PT WAS ASYMPTOMATIC AND TIMI III FLOW WAS ACHIEVED. POST TREATMENT OF THE RCA, THE PHYSICIAN DECIDED TO AGAIN RE-EVALUATE THE CX AND SECOND OM JUNCTURE AND FOUND A 90% STENOSIS DUE TO RECOIL. INFLATIONS WERE AGAIN PERFORMED. A TAXUS EXPRESS2 3.5X8MM STENT WAS EVENTUALLY DEPLOYED IN THE CX AT THE TAKE-OFF OF THE SECOND OM, BUT THE RESULTS WERE UNSATISFACTORY. A FINAL INFLATION WAS PERFORMED AND EXCELLENT RESULTS WERE SEEN IN THE SECOND OM SYSTEM, THE PROXIMAL CX WAS WIDELY PATENT AND THE CX RIGHT AFTER THE SECOND OM HAD A RESIDUAL STENOSIS OF 50%. THREE MONTHS LATER, THE PT PRESENTED WITH THROMBOSIS TO THE STENT THAT STARTS IN THE CX AFTER THE FIRST OM. MULTIPLE INFLATIONS WERE PERFORMED, AND TIMI I FLOW WAS ACHIEVED. A THROMBECTOMY DEVICE WAS THEN USED TO ASPIRATE THE THROMBUS, AND TIMI III FLOW WAS RE-ESTABLISHED. THE STENTS WERE ALL DILATED WITH A MAVERICK 3.5X20MM BALLOON UP TO 16 ATMS. THE PT'S STATUS POST PROCEDURE IS NOTED AS VERY STABLE. MEDICATIONS USED DURING THIS PROCEDURE INCLUDE; NITROGLYCERIN, HEPARIN, REOPRO, MORPHINE, DEMEROL, BENADRYL, VERSED, PLAVIX AND ZOFRAN. THE RCA WAS DETERMINED TO BE PATENT AT THE TIME OF THIS INTERVENTION.

    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 3.5X12MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention