BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2202086 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03226
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 15, 2011
    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

    DESCRIBE EVENT EVENT WAS 427 DAYS POST INDEX PROCEDURE NOT 426 AS INITIALLY STATED. DESCIBE EVENT AND RELEVANT TESTS UPDATED. (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION 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 2134265-2011-03229. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A STENT THROMBOSIS (ST), MYOCARDIAL INFARCTION (MI) AND REQUIRED A TARGET VESSEL REINTERVENTION (TVR). LESION 1 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 70% STENOSIS AND WAS 3 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE PHYSICIAN TREATED THE LESION BY IMPLANTING A 2.75 X 8 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. LESION 2 WAS LOCATED IN PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 70% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. THE PHYSICIAN TREATED THE LESION BY IMPLANTING A 3.00 X 16 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. AT 426 DAYS POST INDEX PROCEDURE, A ST OCCURRED IN THE PROXIMAL AND MID LEFT ANTERIOR DESCENDING ARTERY. CORONARY ANGIOGRAPHY CONFIRMED THE ST. THE PATIENT HAD ISCHEMIC SYMPTOMS AT REST AND ECG CHANGES WERE SUGGESTIVE OF ACUTE ISCHEMIA. THE PATIENT ALSO EXPERIENCED AN ANTERIOR WALL MI AND WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT WAS TREATED WITH A TVR. PRE TREATMENT STENOSIS WAS 100% WHICH WAS REDUCED TO 30% POST TREATMENT. THE PATIENT WAS DISCHARGED THE SAME DAY AND ASPIRIN AND PRASUGREL WERE CONTINUED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE CORONARY ANGIOGRAPHY PERFORMED IN (B)(6) 2010 REVEALED A TOTALLY OCCLUDED RIGHT CORONARY ARTERY AND A LESION IN THE LEFT ANTERIOR DESCENDING THAT WAS FELT NOT TO BE HEMODYNAMICALLY SIGNIFICANT WITH A FLOW STUDY. THE PATIENT WAS TREATED MEDICALLY FOR THESE FINDINGS. TARGET LESION #1 WAS A BIFURCATED LESION TREATED WITH DIRECT STENT PLACEMENT AND POST-DILATATION. TARGET LESION #2 WAS AN OSTIAL LESION TREATED WITH DIRECT STENT PLACEMENT AND POST-DILATATION. AT 427 DAYS POST-INDEX PROCEDURE NOT 426 AS INITIALLY STATED, THE PATIENT DEVELOPED CHEST PAIN AND PRESENTED TO THE ER. ECG'S REVEALED ANTERIOR ST ELEVATIONS. CARDIAC ENZYMES WERE NEGATIVE ON ADMISSION, SUBSEQUENT ENZYMES WERE POSITIVE WITH A PEAK TROPONIN OF 20.35 NG/ML AND THE PATIENT WAS DIAGNOSED WITH AN ANTERIOR WALL MYOCARDIAL INFARCTION THE PATIENT UNDERWENT CORONARY ANGIOGRAPHY WHICH REVEALED A TOTAL THROMBOTIC OCCLUSION OF THE PROXIMAL LAD STENT AT THE OSTIUM. THE THROMBUS WAS TREATED WITH ASPIRATION THROMBECTOMY AND REPEAT ANGIOGRAPHY REVEALED WIDELY PATENT LAD WITHOUT RESIDUAL THROMBUS. INTRACORONARY ULTRASOUND ON REVEALED WELL EXPANDED STUDY STENTS THAT WERE PLACED DURING THE INDEX PROCEDURE. THE PROXIMAL STUDY STENT IN TARGET LESION 2 WAS SOMEWHAT ASYMMETRICALLY EXPANDED NEAR THE ORIGIN OF THE LAD DUE TO A HEAVILY CALCIFIED PLAQUE BUT THE OVERALL LUMEN AREA WAS QUITE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H749389368270 0013258697

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 3.00X16MM TAXUS LIERTE STENT