BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1023396 · Received April 2, 2008

    Report

    Report Number
    2134265-2008-00966
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT THROMBOSIS OCCURRED. THE 100% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED, AVERAGE TORTUOUS PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS ABLATED WITH ROTA 1.25MM AND 1.5MM. SEVERAL INFLATIONS WERE MADE WITH A 2.5X15MM NON-BSC BALLOON. A 2.75X32 MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE DISTAL SIDE OF THE MID RCA AND A 3.00X32MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE PROXIMAL TO MIDDLE RCA. BOTH STENTS WERE INFLATED TO APPROX 12 ATM AND THE 3.00X32MM TAXUS WAS POST DILATED WITH A 2.75X15MM NON-BSC BALLOON, INFLATED AT A HIGH PRESSURE. AN INDENTATION AND 50% STENOSIS REMAINED IN THE 3.00X32MM TAXUS STENT, BUT THE PHYSICIAN CONCLUDED THE PROCEDURE. MEDICATION: TICLOPIDINE AND ASPIRIN. TWO DAYS POST THE INITIAL PROCEDURE, THE PT PRESENTED WITH A CARDIAC ARREST. AN INTRA-AORTIC BALLOON PUMP (IABP) WAS INSERTED AND THROMBOSIS WAS IDENTIFIED IN THE 100% STENOSED PROXIMAL RCA. THE THROMBOSIS WAS ASPIRATED WITH NON-BSC THROMBECTOMY DEVICE AND LESION WAS DILATED WITH 2.5X15MM NON-BSC BALLOON AND A 2.75X15MM NON-BSC BALLOON, INFLATED TO 26 ATM. DESPITE DILATATION THE INDENTATION REMAINED AND THROMBUS REFORMED. THE PHYSICIAN CHANGED THE METHOD OF TREATMENT TO CORONARY ARTERY BYPASS GRAFT (CABG). MEDICATION: TICLOPIDINE, ASPIRIN, HEPARIN, PANALDIN. SEVEN DAYS POST THE INITIAL PROCEDURE, THE PATIENTS MEDICATIONS WERE CHANGED FOR CABG. IN THE AFTERNOON, THE PT EXPERIENCED VENTRICULAR FIBRILLATION AND WAS 'SHOCKED'. THROMBUS WAS SUSPECTED. A TOTAL OCCLUSION WAS IDENTIFIED IN THE DISTAL SIDE OF THE PREVIOUSLY PLACED 3.00X32MM TAXUS STENT. THE THROMBUS WAS ASPIRATED AND THE LESION WAS DILATED WITH A 2.75X15MM QUANTUM MAVERICK BALLOON, A 3.0X13MM NON-BSC BALLOON, AND A 2.25X15MM QUANTUM MAVERICK2 BALLOON. A THROMBUS REFORMED AND THE LESION WAS FURTHER DILATED WITH A 3.0X30MM MAVERICK BALLOON AND A 3.0X15MM NON-BSC BALLOON. THE INDENTATION STILL REMAINED. MEDICATION: ASPIRIN, CILOSTAZOL, PLETAAR AND SLONNON. CABG WAS PERFORMED NINE DAYS AFTER THE INITIAL PROCEDURE. THE PHYSICIAN FEELS THE EVENT WAS RELATED WITH INCOMPLETE DILATATION.

    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 2.75X32 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention RIVERS THROMBECTOMY DEVICE| CATENACCIO BALLOON| HIRYU BALLOON| POWERED LACROSS BALLOON