BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 786199 · Received November 17, 2006

    Report

    Report Number
    6000093-2006-02378
    Event Type
    Injury
    Date Received
    November 17, 2006
    Date of Event
    October 11, 2006
    Report Date
    October 20, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    PMA / PMN Number
    p030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    H6. THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THEREFORE NO ANALYSIS COULD BE PERFORMED. THE REPORTED BATCH NUMBER 7213710 WAS REWORKED FROM TOP ASSEMBLY BATCH NUMBER 6163195. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 6163195 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ELIMINATE AND MITIGATE AGAINST A RECURRENCE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AND EIGHT MONTHS AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE STENT THROMBOSIS OCCURRED. PRIOR TO THE INDEX PROCEDURE THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME AND IT WAS DECIDED TO PERFORM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). A LONG LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A TAXUS EXPRESS2 3.00X24MM DRUG ELUTING STENT (DES) WAS SUCCESSFULLY IMPLANTED IN THE LAD. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS USING ASPIRIN AND PLAVIX DAILY UNTIL APPROXIMATELY ONE YEAR AND EIGHT MONTHS LATER, SHE WAS HOSPITALIZED DUE TO WORSENING OF LEFT VENTRICULAR FUNCTION AND THEN AN ANTERIOR MYOCARDIAL INFARCTION OCCURRED. CARDIAC INSUFFICIENCY WAS NOTED WITH AN EJECTION FRACTION OF 30% (IN 2005 IT WAS 80%). THROMBOSIS WAS REVEALED IN THE MID PORTION OF THE PREVIOUSLY PLACED TAXUS STENT. THERE WAS AN ATTEMPT MADE TO RE-OPEN THE ARTERY THROUGH EMERGENT PTCA BUT WAS UNSUCCESSFUL. THE ONLY FURTHER INTERVENTION TO TREAT THE PATIENT WAS TO ADD AN ACE INHIBITOR TO HER MEDICATION REGIMEN. THE PATIENT IS REPORTED TO BE "OKAY." IT WAS REPORTED THAT THE PHYSICIAN "HAD GREAT DIFFICULTY IN CONCLUDING THAT IN-STENT THROMBOSIS HAD OCCURRED OR IF RESTENOSIS OCCURRED. THE ANGIOGRAPHY RESULTS WERE NOT CONCLUSIVE. THE PATIENT HAD BEEN COMPLIANT WITH MEDICATION SO HE IS UNSURE WHY THE THROMBOSIS OCCURRED."

    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 CORP. 3.00X24MM 6163195

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R