BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2838290 · Received November 19, 2012

    Report

    Report Number
    2134265-2012-07087
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    January 14, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER - THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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: 2134265-2012-06255. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. IN (B)(6) 2010, THE PATIENT WAS HOSPITALIZED WITH UNCONTROLLED DIABETES. DUE TO SUBSEQUENT UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION: IIA), CARDIAC CATHETERIZATION WAS RECOMMENDED. LESION 1 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS 85% STENOSED, 3.5MM IN DIAMETER AND 18MM LONG. THE LESION WAS TREATED WITH DIRECT PLACEMENT USING A 3.5X24MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. LESION 2 WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX (CX). THE LESION WAS 75% STENOSED, 4.0MM IN DIAMETER AND 12MM LONG. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 4.0X16MM TAXUS LIBERTE STENT. FOLLOWING POST DILATION WITH A NON-BSC BALLOON, SMALL PERFORATION WAS TREATED WITH PLACEMENT OF TWO (NON-BSC) STENTS. RESULT WAS 0% STENOSIS WITH SEALING OF PERFORATION WITH SEALING OF PERFORATION. IN JANUARY 2012, THE PATIENT PRESENTED WITH MID STERNAL CHEST PAIN RADIATING TO BOTH ARMS AND ASSOCIATED WITH WAS AND VOMITING. ELECTROCARDIOGRAM REVEALED CONSISTENT WITH ACUTE INFARCT. CARDIAC ENZYMES WERE NOTED TO BE ELEVATED CONSISTENT WITH PROTOCOL DEFINITION OF MYOCARDIAL INFARCTION. THE PROXIMAL LCX WAS TREATED WITH NON-BSC EXTRACTION CATHETER AND BALLOON ANGIOPLASTY. FOLLOWING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND THROMBECTOMY, 80% DISTAL EDGE STENOSIS OF THE PREVIOUSLY PLACED NON-BSC COVERED STENT WAS TREATED WITH PLACEMENT OF THREE NON-BSC STENTS ( 2.75 X 15 MM, 2.50 X 15 MM AND 3.00 X 15 MM). RESIDUAL STENOSIS WAS 0%. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ASPIRIN ONLY. LATER IN JANUARY 2012, LABORATORY INVESTIGATION REVEALED HEMOGLOBIN 10.0 G/DL (REF. RANGE:12.0-6.0 G/DL) AND HEMATOCRIT 29% (REF. RANGE: 36-46%). LABORATORY INVESTIGATION REVEALED HEMOGLOBIN 9.0 G/DL AND HEMATOCRIT 27.2%. THE PATIENT COMPLAINED OF ABDOMINAL PAIN ASSOCIATED WITH LIQUID STOOLS. THE MID RCA WAS TREATED WITH PLACEMENT OF A NON-BSC STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893624350 13148062

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R