BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® ATOM?

    MDR report key: 3202889 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04608
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    August 6, 2010
    Report Date
    June 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE RETURNED TO 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

    (B)(4). SAME CASE AS: MDR ID# 2134265-2013-04602. IT WAS REPORTED THAT SUBSEQUENT TO A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, PROGRESSION OF CORONARY ARTERY DISEASE AND JAILING OF THE DIAGONAL BRANCH OCCURRED. ON (B)(6) 2010, THE PATIENT PRESENTED WITH SUBSTERNAL CHEST PAIN WITH MILD TINGLING IN BILATERAL ARMS ASSOCIATED WITH MILD SHORTNESS OF BREATH AND NAUSEA. THE PATIENT WAS DIAGNOSED WITH SILENT ISCHEMIA AND NON ST ELEVATION MYOCARDIAL INFARCTION (KILLIP CLASSIFICATION: II). CARDIAC CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY PERFORMED REVEALED 100% OCCLUSION IN LEFT ANTERIOR DESCENDING ARTERY (LAD) AND 80% OCCLUSION IN RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS REFERRED FOR PCI. THREE DAYS LATER, THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS A DE-NOVO LESION LOCATED IN MID RCA WITH 75-80% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THIS WAS TREATED WITH IVUS AND PRE-DILATATION FOLLOWED BY PLACEMENT OF A 4.00 X 12 MM TAXUS LIBERTE STENT OVERLAPPED DISTALLY BY A 4.00 X 38 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. POST-STENT DEPLOYMENT, IVUS REVEALED INCOMPLETE APPOSITION WHICH WAS TREATED WITH POST-DILATATION WITH A NON-COMPLIANT BALLOON. ONE DAY POST INDEX PROCEDURE, THE PATIENT WAS TREATED WITH STENT PLACEMENT IN LAD. TARGET LESION #2 WAS A DE-NOVO LESION LOCATED IN MID LAD WITH 100% STENOSIS AND WAS 50 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THIS WAS TREATED WITH IVUS AND PRE-DILATATION FOLLOWED BY PLACEMENT OF A 2.25 X 32 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #3 WAS A DE-NOVO LESION LOCATED IN PROXIMAL LAD WITH 100% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THIS WAS TREATED WITH IVUS AND PRE-DILATATION FOLLOWED BY PLACEMENT OF A 3.00 X 32 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. DURING THE STAGED PROCEDURE, THE PLACEMENT OF STENTS IN LAD RESULTED IN JAILING OF THE DIAGONAL BRANCH WHICH WAS TREATED WITH BALLOON ANGIOPLASTY, REDUCING THE 90% STENOSIS TO 0%. THREE DAYS POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301393 TAXUS® LIBERTÉ® ATOM? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893632220 0012751924

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention