BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3000025 · Received March 12, 2013

    Report

    Report Number
    2134265-2013-01312
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    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

    AGE AT TIME OF EVENT: 70'S. IF IMPLANTED, GIVE DATE: "ABOUT A YEAR AGO". DEVICE IS COMBINATION PRODUCT. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS 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 STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. THE PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. AN UNSPECIFIED 3.0X32MM TAXUS STENT WAS IMPLANTED "ABOUT A YEAR AGO". IN (B)(6) 2013, THE PATIENT RETURNED WITH IN-STENT RESTENOSIS. WITHOUT PRE-DILATION, AN ATLANTIS CATHETER WAS ADVANCED TO THE TARGET LESION BUT WAS NOT ABLE TO CROSS THE LESION AND WAS REPLACED WITH A NON-BSC IMAGING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104194 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention