BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® EXPRESS²®

    MDR report key: 2212504 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03366
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS USER/USE ERROR. THE PHYSICIAN REPORTED THAT THE THROMBOSIS OCCURRED DUE THE CANCELLATION OF THE DUAL ANTIPLATELET THERAPY (DAPT). THE DFU STATES, "PREMATURE DISCONTINUATION OF PRESCRIBED ANTIPLATELET MEDICATION COULD RESULT IN A HIGHER RISK OF THROMBOSIS, MYOCARDIAL INFARCTION OR DEATH". (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT WAS PREVIOUSLY REPORTED THAT THE MOST PROBABLE ROOT CAUSE WAS USER ERROR. THE MOST PROBABLE ROOT CAUSE HAS BEEN CORRECTED TO ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT DEVELOPED STENT THROMBOSIS. IN DECEMBER 2008 DURING AN EMERGENT PROCEDURE DUE TO AN ACUTE MYOCARDIAL INFARCTION, A 3.5X16MM, 90% STENOSED, PROXIMALLY TORTUOUS, BIFURCATED LESION OF THE MID LAD (LEFT ANTERIOR DESCENDING) AND 1ST DIAGONAL ARTERIES WAS TREATED. TREATMENT CONSISTED OF PRE-DILATION WITH A 2.5MM BALLOON AT 18ATM IN THE MID LAD AND 1ST DIAGONAL AND PLACEMENT OF A 3.5X16MM TAXUS EXPRESS2 STENT IN THE MID LAD AT 6ATM FOR 20 SECONDS. ANOTHER BALLOON INFLATION IN THE 1ST DIAGONAL AND POST DILATION OF THE STENT WERE COMPLETED AND IVUS (INTRAVASCULAR ULTRASOUND) CONFIRMED THE LESION WAS DILATED ENOUGH TO COMPLETE THE PROCEDURE. THERE WAS 0% RESIDUAL STENOSIS WITH TIMI 3 FLOW AND NO MALAPPOSITION OF THE STENT. THE PATIENT WAS DISCHARGED THE NEXT DAY. IN (B)(6) 2011 THE PATIENT PRESENTED WITH CHEST PAIN. ECG SHOWED A STENT THROMBOSIS. THROMBECTOMY WAS PERFORMED AND INTRAVENOUS MEDICATIONS WERE ADMINISTERED. THE PATIENT STATUS WAS RECOVERED. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING BAYASPIRIN ONLY. PANALDINE WAS CHANGED TO PLAVIX IN (B)(6) 2008 DUE TO HEPATIC DYSFUNCTION AND PLAVIX WAS DISCONTINUED IN (B)(6) 2010. THE PATIENT RE-STARTED PLAVIX IN (B)(6) 2011. THE PHYSICIAN FELT THAT THE THROMBOSIS EVENT WAS DUE TO DISCONTINUATION OF THE PATIENT'S DUAL ANTIPLATELET THERAPY AND WAS NOT RELATED TO THE TAXUS EXPRESS2 STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT DEVELOPED STENT THROMBOSIS. IN (B)(6) 2008 DURING AN EMERGENT PROCEDURE DUE TO AN ACUTE MYOCARDIAL INFARCTION, A 3.5X16MM, 90% STENOSED, PROXIMALLY TORTUOUS, BIFURCATED LESION OF THE MID LAD (LEFT ANTERIOR DESCENDING) AND 1ST DIAGONAL ARTERIES WAS TREATED. TREATMENT CONSISTED OF PRE-DILATION WITH A 2.5MM BALLOON AT 18ATM IN THE MID LAD AND 1ST DIAGONAL AND PLACEMENT OF A 3.5X16MM TAXUS EXPRESS2 STENT IN THE MID LAD AT 6ATM FOR 20 SECONDS. ANOTHER BALLOON INFLATION IN THE 1ST DIAGONAL AND POST DILATION OF THE STENT WERE COMPLETED AND IVUS (INTRAVASCULAR ULTRASOUND) CONFIRMED THE LESION WAS DILATED ENOUGH TO COMPLETE THE PROCEDURE. THERE WAS 0% RESIDUAL STENOSIS WITH TIMI 3 FLOW AND NO MALPOSITION OF THE STENT. THE PATIENT WAS DISCHARGED THE NEXT DAY. IN (B)(6) 2011 THE PATIENT PRESENTED WITH CHEST PAIN. ECG SHOWED A STENT THROMBOSIS. THROMBECTOMY WAS PERFORMED AND INTRAVENOUS MEDICATIONS WERE ADMINISTERED. THE PATIENT STATUS WAS RECOVERED. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING BAYASPIRIN ONLY. PANALDINE WAS CHANGED TO PLAVIX IN (B)(6) 2008 DUE TO HEPATIC DYSFUNCTION AND PLAVIX WAS DISCONTINUED IN (B)(6) 2010. THE PATIENT RE-STARTED PLAVIX IN (B)(6) 2011. THE PHYSICIAN FELT THAT THE THROMBOSIS EVENT WAS DUE TO DISCONTINUATION OF THE PATIENT'S DUAL ANTIPLATELET THERAPY AND WAS NOT RELATED TO THE TAXUS EXPRESS2 STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® EXPRESS²® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897016350

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention