BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2893643 · Received January 2, 2013

    Report

    Report Number
    2134265-2012-08113
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    January 29, 2012
    Report Date
    December 6, 2012
    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. DEVICE EVALUATION BY MANUFACTURER: 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

    SAME CASE AS MDR ID#2134265-2012-08114. (B)(4) STUDY. IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. IN (B)(6) 2010 THE PATIENT PRESENTED WEEK LONG HISTORY OF CHEST PAIN ASSOCIATED WITH SHORTNESS OF BREATH. THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND NON ST ELEVATION MYOCARDIAL INFARCTION AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 70% STENOSED AND 10MM LONG FIRST TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE FIRST TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.75X12MM TAXUS LIBERTE STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE 70% STENOSED AND 20MM LONG SECOND TARGET LESION WAS LOCATED IN A MID RCA WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE SECOND TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.75X24MM TAXUS LIBERTE STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, THE PATIENT PRESENTED WITH A WEEK LONG HISTORY OF CHEST PAIN. ECG CHANGES INDICATED POSSIBLE ISCHEMIA. CARDIAC ENZYMES WERE NOTED TO BE ELEVATED CONSISTENT WITH MYOCARDIAL INFARCTION. IT WAS NOTED THAT THERE WAS A 'SIGNIFICANT AMOUNT OF CLOT IN THE DISTAL PORTION OF THE VESSEL WHICH OCCLUDES THE RPL.' THE PATIENT WAS REFERRED FOR PERCUTANEOUS CORONARY INTERVENTION. TARGET VESSEL REVASCULARIZATION WAS PERFORMED. IT WAS NOTED THAT THE DISTAL PORTION OF THE POSTEROLATERAL BRANCH WAS WIRED WHEN THE SUBJECT WENT INTO VENTRICULAR FIBRILLATION, REQUIRING CARDIOVERSION. IV AMINODARONE WAS INITIATED. THE CLOT IN THE DISTAL RCA, OCCLUDING THE 1ST RPL WAS TREATED WITH BALLOON ANGIOPLASTY. BALLOON ANGIOPLASTY OF THE DISTAL RCA WAS ALSO PERFORMED, USING THE SAME DEVICE. THE PROXIMAL RCA WAS TREATED WITH DIRECT PLACEMENT OF 3.50X24MM ION STENT, RESULTING IN 0% RESIDUAL STENOSIS. AN INTRA-AORTIC BALLOON PUMP WAS PLACED FOR HEMODYNAMIC INSTABILITY, AND FURTHER BALLOONING WAS PERFORMED TO THE ENTIRE SEGMENT WITH RESTORATION OF TIMI 3 FLOW. THE MID RCA WAS THEN TREATED WITH PLACEMENT OF 3.50X8 MM ION STENT. REPEAT ANGIOGRAPHY DEMONSTRATED RESIDUAL CLOT IN THE DISTAL RCA WHICH WAS BALLOONED FURTHER. FINAL ANGIOGRAMS REVEALED TIMI 3 FLOW EXCEPT FOR A SMALL AREA OF NO FLOW IN THE VERY DISTAL PORTION OF THE R-PLV. THE IABP WAS REMOVED WITHIN 24-48 HOURS. A COUPLE DAYS LATER THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612270 13356957

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention