BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2972894 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00876
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 24, 2013
    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

    DEVICE IS COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). THE 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 MDR ID #2134265-2013-00885. IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. IN (B)(6) 2010, THE PATIENT PRESENTED WITH RIGHT SIDED CHEST PRESSURE AND TIGHTNESS ASSOCIATED WITH DIAPHORESIS, DYSPNEA AND FATIGUE AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 80% STENOSED AND 12MM LONG FIRST TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE FIRST TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.0X16MM TAXUS LIBERTE STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE 90% STENOSED AND 10MM LONG DE-NOVO SECOND TARGET LESION WAS LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.9MM. THE SECOND TARGET LESION WAS TREATED WITH DIRECT OVERLAPPING STENT PLACEMENT OF TWO 2.50X8MM TAXUS LIBERTE STENTS, RESULTING IN 0% RESIDUAL STENOSIS POST DILATION. THE PATIENT RETURNED THE FOLLOWING DAY FOR A STAGED STENT PLACEMENT PROCEDURE. THE 80% STENOSED AND 10MM LONG DE-NOVO THIRD TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.2MM. THE THIRD TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 2.25X 16MM TAXUS ATOM STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN DECEMBER 2011 THE PATIENT RECEIVED PLACEMENT OF A 2.50X18MM NON BSC STENT IN THE DISTAL RIGHT CORONARY ARTERY EXTENDING TO THE 1ST RIGHT POSTEROLATERAL BRANCH. IN JANUARY 2013 THE PATIENT PRESENTED WITH SUBSTERNAL CHEST PAIN RADIATING TO SHOULDER AND JAW AND WAS HOSPITALIZED ON THE SAME DAY. ELECTROCARDIOGRAPHY REVEALED POSSIBLE ANTERIOR AND INFERIOR INFARCT WITH T WAVE INVERSION IN INFERIOR LEADS. THE PATIENT WAS DIAGNOSED WITH ACUTE INFERIOR WALL MYOCARDIAL INFARCTION AND CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY REVEALED A 100% TOTAL OCCLUSION OF THE NON BSC STENT IN THE DISTAL RIGHT CORONARY ARTERY EXTENDING TO THE 1ST RIGHT POSTEROLATERAL BRANCH. THE OCCLUSION WAS TREATED WITH PRE-DILATION WITH RESTORATION OF TIMI III FLOW IN THE DISTAL RIGHT CORONARY ARTERY. THE 100% TOTAL OCCLUSION OF STUDY STENTS IN RIGHT POSTERIOR DESCENDING ARTERY WERE TREATED WITH PRE-DILATATION WITH RESTORATION OF FLOW IN RIGHT POSTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION, RESIDUAL STENOSIS WAS 90% WHICH WAS TREATED WITH PLACEMENT OF A 2.50X8 MM NON BSC STENT, RESULTING IN 0% RESIDUAL STENOSIS. IN ADDITION TO THIS EVENT A SECOND WIRE WAS PASSED THROUGH THE PREVIOUSLY PLACED NON BSC STENT IN THE DISTAL PORTION OF 1ST RIGHT POSTEROLATERAL BRANCH AND BALLOON ANGIOPLASTY WAS PERFORMED. TWO DAYS LATER THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75740 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H749389378250 13323365

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention