BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® ATOM?

    MDR report key: 3201268 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04604
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 4, 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)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 PATIENT AS MDR ID#2134265-2010-04884, #2134265-2010-04885, #2134265-2013-04608 AND #2134265-2013-04602. IT WAS FURTHER REPORTED THAT IN (B)(6) 2013 THE PATIENT PRESENT TO THE HOSPITAL. AN ECG REPORTED AT THE TIME OF ADMISSION REVEALED MARKED SINUS BRADYCARDIA, LEFT VENTRICULAR HYPERTROPHY WITH REPOLARIZATION ABNORMALITY, SEPTAL INFARCT. ST SEGMENT SHOWED MARKED ABNORMALITY WHEN EXERCISING AND NUCLEAR SCANS SHOWED MIXED ANTEROAPICAL SCAR AND ISCHEMIA. THE SUBJECT WAS DIAGNOSED WITH NON-Q WAVE MYOCARDIAL INFARCTION AND CARDIAC CATHETERIZATION WAS RECOMMENDED. IN (B)(6) 2013 THE SUBJECT WAS DIAGNOSED WITH PROGRESSIVE CORONARY ARTERY DISEASE AND THE SUBJECT WAS HOSPITALIZED. TVR WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING THE INITIAL INDEX PROCEDURE, POST DEPLOYMENT OF THE STENTS, IVUS REVEALED INCOMPLETE APPOSITION WHICH WAS TREATED WITH POST DILATATION WITH A NONCOMPLIANT BALLOON. AT THE TIME OF THE STAGED INDEX PROCEDURE, TARGET LESION #2 CONTAINED PRE-EXISTING THROMBUS. PLACEMENT OF THE STENTS IN THE LAD RESULTED IN JAILING OF THE 2ND DIAGONAL BRANCH. TREATMENT WITH BALLOON ANGIOPLASTY REDUCED THE 90% STENOSIS TO 0%.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2134265-2013-04603, 2134265-2013-04605, 2134265-2013-04606. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, PROGRESSION OF CORONARY ARTERY DISEASE OCCURRED. ON (B)(6) 2010, THE SUBJECT PRESENTED WITH SUBSTERNAL CHEST PAIN WITH MILD TINGLING IN BILATERAL ARMS ASSOCIATED WITH MILD SHORTNESS OF BREATH AND NAUSEA. THE SUBJECT 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 LAD AND 80% OCCLUSION IN RCA. THE SUBJECT WAS REFERRED FOR PCI. THREE DAYS LATER, THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS A DE-NOVO LONG LESION, LOCATED IN MID RIGHT CORONARY ARTERY (RCA) EXTENDING TILL PROXIMAL 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 WITH 0% RESIDUAL STENOSIS. A DAY POST PROCEDURE, THE PATIENT WAS TREATED WITH STENT PLACEMENT IN THE LEFT ANTERIOR DESCENDING ARTERY (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. TARGET LESION #2 WAS TREATED WITH IVUS AND PRE-DILATATION FOLLOWED BY PLACEMENT OF A 2.25 X 32 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION #3 WAS A DE-NOVO LONG LESION, LOCATED IN MID LAD EXTENDING TILL 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 OVERLAPPING PROXIMALLY WITH 2.25 X 32 MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE PLACEMENT OF STENTS IN LAD RESULTED IN JAILING OF THE 2ND DIAGONAL BRANCH WHICH WAS TREATED WITH BALLOON ANGIOPLASTY, REDUCING THE 90% STENOSIS TO 0%. THREE DAYS AFTER THE PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. ON (B)(6) 2013, THE SUBJECT CAME FOR OFFICE VISIT WITH CHEST TIGHTNESS AND WAS DIAGNOSED WITH STABLE ANGINA. CARDIAC CATHETERIZATION WAS RECOMMENDED. THE LEFT ANTERIOR DESCENDING ARTERY WAS OCCLUDED ¿SHORTLY AFTER THE ORIGIN WITHIN A STENTED SEGMENT¿ (PREVIOUSLY PLACED STENTS DURING THE STAGED PROCEDURE). EIGHTY PERCENT SEVERE FOCAL IN-STENT RESTENOSIS IN PROXIMAL RCA WAS TREATED BY DIRECT STENT PLACEMENT USING A 4.00 X 15 MM NON BSC DRUG-ELUTING STENT, RESULTING IN 0% RESOLUTE STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301556 TAXUS® LIBERTÉ® ATOM? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893632220 0012751924

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention