BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3241375 · Received July 22, 2013

    Report

    Report Number
    2134265-2013-04978
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY STENTING PROCEDURE, TARGET VESSEL FAILURE OCCURRED. IN (B)(6) 2010 THE SUBJECT WAS DIAGNOSED WITH STABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION #1 WAS A DE NOVO LESION, LOCATED IN THE MID SEGMENT OF SVG TO MID RCA WITH 70% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.95 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.00 MM X 28 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0.5 %. THE SUBJECT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013 THE SUBJECT WAS DIAGNOSED WITH TARGET VESSEL FAILURE. AT THE TIME OF REPORTING THE OUTCOME OF EVENT IS RECOVERING/ RESOLVING.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT PATIENT PRESENTED WITH RECURRENT CHEST PAIN WHICH WAS PREVIOUSLY REPORTED AS RIGHT CORONARY ARTERY ANGIOPLASTY AND STENTING. AND ALSO, IT WAS IN (B)(6) 2013 THAT THE 100% IN STENT RESTENOSIS FROM SVG TO MID RCA RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN JUNE 2013 THE SUBJECT PRESENTED FOR RIGHT CORONARY ARTERY ANGIOPLASTY AND STENTING. THE SUBJECT WAS ON ASPIRIN BUT NOT ON THE STUDY DRUG DURING THIS EVENT. THE STUDY DRUG WAS LAST TAKEN IN MARCH 2013. THE VEIN GRAFT TO THE RIGHT CORONARY ARTERY WAS COMPLETELY OCCLUDED AND HENCE CARDIAC CATHETERIZATION WAS RECOMMENDED.ON AN UNKNOWN DATE, THE COMPLETELY OCCLUDED RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A PROMUS ELEMENT DRUG ELUTING STENT. IN (B)(6) 2013, THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCAHRGED ON THE SAME DAY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2013, THE PATIENT WAS DIAGNOSED WITH ANGINA (CCS CLASS: II) AND WAS HOSPITALIZED ON THE SAME DAY. THE RESTENOSIS WAS ALSO UP TO PROXIMAL RCA WHICH WAS PREVIOUSLY REPORTED AS MID RCA.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-01402 AND 2134265-2014-01403. IT WAS FURTHER REPORTED THAT IN (B)(6) 2013, STENT THROMBOSIS OCCURRED AND CORONARY ANGIOGRAPHY REVEALED 'COMPLETELY OCCLUDED AT THE PROXIMAL EDGE OF THE STUDY STENT'. THE OTHER ANTIPLATELET MEDICATION WAS NEVER TAKEN DURING THIS STUDY. CARDIAC CATHETERIZATION WAS RECOMMENDED. THE STENOSIS IN THE NATIVE PROXIMAL RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH PLACEMENT OF A 3.0X22MM PROMUS ELEMENT STENT, RESULTING IN 0% RESIDUAL STENOSIS. POST CATHETERIZATION, THE PATIENT DEVELOPED CHEST PAIN SO RECATHETERIZATION WAS PERFORMED THE FOLLOWING DAY, WHICH REVEALED A PROBABLE DISSECTION INDUCED BY PT2 GUIDEWIRES USED IN PREVIOUS CATHETERIZATION WHICH RESULTED IN SPASM IN DISTAL RCA. THE SPASM WAS TREATED WITH ADMINISTRATION OF NITROGLYCERIN AFTER WHICH THE AREA PLUMPED UP VERY WELL. ELECTROCARDIOGRAM (ECG) REVEALED ST ELEVATIONS SUGGESTIVE OF ACUTE MYOCARDIAL INFARCTION (MI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340334 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893628300 12778925

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O