BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2863286 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07615
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    June 19, 2010
    Report Date
    November 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    SAME CASE AS MDR ID #2134265-2012-07455. (B)(4). IT WAS REPORTED THAT POST A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2009, THE PATIENT HAD 3 TAXUS STENTS IMPLANTED IN THE CIRCUMFLEX ARTERY AND ONE TAXUS ATOM IMPLANTED IN THE OBTUSE MARGINAL ARTERY. IN (B)(6) 2010, THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME WITH LASTING PAIN LESS THAN 24 HOURS. THE 90% IN-STENT RE-STENOSED TARGET LESION WAS LOCATED IN THE IN THE MIDDLE OF THE MID CIRCUMFLEX ARTERY. THE TARGET LESION WAS DILATED 3 TIMES TO 16 ATM WITH AN UNKNOWN MANUFACTURER'S 3.00MM BALLOON CATHETER. THE TARGET LESION WAS TREATED WITH PLACEMENT OF A 24X3.00MM TAXUS LIBERTE STENT, RESULTING IN 10% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT EXPERIENCED INCREASING FATIGUE AND WEAKNESS AND SNEEZING. THE PATIENT BEGAN TO NOTICE SHORTNESS OF BREATH WITH EXERTION, THE PATIENT'S SHORTNESS OF BREATH FAILED TO IMPROVE. IN (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA. THE PATIENT UNDERWENT DIAGNOSTIC TESTING WHICH REVEALED 90% IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED TAXUS STENT IN THE DISTAL CIRCUMFLEX ARTERY AND THE PATIENT UNDERWENT REPEAT PERCUTANEOUS CORONARY INTERVENTION. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED, EVENT IS CONSIDERED RECOVERED AND RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention