BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2091978 · Received May 18, 2011

    Report

    Report Number
    2134265-2011-01930
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT 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

    SAME CASE AS MFR REPORT #: 2134265-2011-01775, 2134265-2011-01776. (B)(4) TRIAL. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE RESTENOSIS OCCURRED. THE INDEX PROCEDURE TREATED TWO TARGET LESIONS IN (B)(6) 2010. TARGET LESION ONE WAS AN 80% STENOSIS OF THE OM2 (2ND OBTUSE MARGINAL) MEASURING 2.75X14MM. TREATMENT CONSISTED OF DIRECT STENTING WITH A 2.75X16MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. TARGET LESION TWO WAS A 75% STENOSIS OF THE MID LAD (LEFT ANTERIOR DESCENDING) MEASURING 2.75X24MM. TREATMENT CONSISTED OF DIRECT STENTING USING A 2.75X28MM AND 2.75X12MM TAXUS LIBERTE STENTS RESULTING IN 0% RESIDUAL STENOSIS. ACCORDING TO SOURCE, THERE WAS "EXCELLENT ANGIOGRAPHIC APPEARANCE WITH A 0% RESIDUAL STENOSIS, EXCEPT FOR A MYOCARDIAL BRIDGE". THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. THE PATIENT RETURNED IN (B)(6) 2011 WITH RECURRENT EXERTIONAL ANGINA. IN (B)(6) 2011 A NUCLEAR STRESS TEST REVEALED A "LARGE AMOUNT OF ISCHEMIA IN BOTH THE DISTRIBUTION OF THE LAD AND RIGHT CORONARY ARTERY". THE PATIENT WAS ADMITTED AND CARDIAC CATHETERIZATION WAS PERFORMED 12 DAYS LATER WHICH REVEALED A "99% STENOSIS AT THE SITE OF A PRIOR STENT, IN-STENT, PROXIMAL TO STENT... LARGE FILLING DEFECT CONSISTENT WITH THROMBUS" AT THE LAD AND A DISTAL LAD 99% STENOSIS WITH A LARGE FILLING DEFECT CONSISTENT WITH THROMBUS. THE SITE ALSO NOTED DIFFUSE IN-STENT RESTENOSIS OF THE LAD. THE MID LAD WAS TREATED WITH THROMBECTOMY, BALLOON ANGIOPLASTY, AND PLACEMENT OF A NON-BSC 3.0X30MM STENT RESULTING IN 0% RESIDUAL STENOSIS. THE LEFT CIRCUMFLEX (LCX) SYSTEM SHOWED MINOR LUMINAL IRREGULARITIES, MODERATE ATHEROSCLEROSIS IN THE RAMUS, AND 85% STENOSIS IN THE PROXIMAL RAMUS. THE PROXIMAL LCX WAS TREATED WITH A 3.0X15MM NON-BSC STENT. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. THE PATIENT WAS REPORTED TO BE COMPLIANT WITH ANTI-PLATELET MEDICATIONS AND MEDICATIONS WERE NOT STOPPED AT ANY TIME. THE PATIENT HAD MYOCARDIAL BRIDGING AND THE CARDIOLOGIST FEELS THAT IS THE CAUSE OF THE STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616270 13341946

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention