BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3180269 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04286
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    April 20, 2013
    Report Date
    July 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). 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).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE EVENT TERM UPDATED FROM ¿WORSENING CORONARY ARTERY DISEASE¿ TO ¿CORONARY ARTERY DISEASE TO SEGMENT ELEVATION POSTEROLATERAL INFARCT.¿

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR ID: 2134265-2013-04284. IT WAS REPORTED THAT POST PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, IN-STENT RESTENOSIS,STENT THROMBOSIS AND MYOCARDIAL INFARCTION OCCURRED. IN (B)(6) 2010, THE SUBJECT PRESENTED WITH SEVERE CHEST PAIN AND WAS DIAGNOSED WITH ST ELEVATION MYOCARDIAL INFARCTION. CARDIAC CATHETERIZATION WAS RECOMMENDED. THE INDEX PROCEDURE WAS PERFORMED AND THE SUBJECT WAS ENROLLED IN THE (B)(4). TARGET LESION #1 WAS A DE-NOVO LESION, WITH A PRE-EXISTING THROMBUS, LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY WITH 70% STENOSIS AND WAS 16MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. TARGET LESION #1 WAS TREATED WITH THROMBECTOMY AND PRE-DILATATION FOLLOWED BY PLACEMENT OF A 3.00 X 24 MM TAXUS LIBERTE STENT. THE STENT WAS DEPLOYED IN THE MID SEGMENT OF THE CIRCUMFLEX EXTENDING UP TO THE JUNCTION OF LEFT POSTEROLATERAL ARTERY. FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS A DE-NOVO LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY WITH 100% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. TARGET LESION #2 WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.00 X 20 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION #3 WAS A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 90% STENOSIS AND WAS 25 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. TARGET LESION #3 WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 2.75 X 32 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATION, THE RESIDUAL STENOSIS WAS 0%. TARGET LESION #4 WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WITH 80% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. TARGET LESION #4 WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 2.50 X 20 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATION, THE RESIDUAL STENOSIS WAS 0%. ON THE THIRD DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. ON (B)(6) 2013, THE SUBJECT PRESENTED WITH ACUTE SUBSTERNAL CHEST PAIN RADIATING TO HIS LEFT ARM ASSOCIATED WITH SHORTNESS OF BREATH AND NAUSEA. ELECTROCARDIOGRAM REVEALED NORMAL SINUS RHYTHM WITH ST ELEVATION INFERIORLY. CARDIAC ENZYMES WERE ELEVATED, CONSISTENT WITH THE PROTOCOL DEFINITION OF MYOCARDIAL INFARCTION. THE SUBJECT WAS DIAGNOSED WITH ST ELEVATION MYOCARDIAL INFARCTION AND WAS HOSPITALIZED ON THE SAME DAY. CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 75% FOCAL IN-STENT RESTENOSIS OF THE STUDY STENT IN DISTAL LEFT CIRCUMFLEX ARTERY, WITH THROMBUS WAS TREATED WITH THROMBECTOMY, BALLOON ANGIOPLASTY, AND PLACEMENT OF 3.00 X 30MM NON-BSC STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0%. THE 90% IN-STENT RESTENOSIS OF STUDY STENT IN DISTAL LEFT CIRCUMFLEX ARTERY, WITH THROMBUS WAS TREATED WITH THROMBECTOMY AND BALLOON ANGIOPLASTY, WITH 0% RESIDUAL STENOSIS. THE 70% STENOSIS IN FIRST LEFT POSTEROLATERAL ARTERY WAS TREATED WITH PLACEMENT OF 2.50 X 18MM NON-BSC STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON THE SECOND DAY WITH ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE, TARGET LESION #1 WAS 100% STENOSED, NOT 70% AS PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280381 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893620300 13157016

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention