BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ ELEMENT¿

    MDR report key: 3023796 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01903
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    October 4, 2011
    Report Date
    February 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS MDR ID#: 2134265-2011-05050, 2134265-2012-00224, 2134265-2012-00225, 2134265-2013-01902, 2134265-2013-01904, 2134265-2013-01905. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD MYOCARDIAL INFARCTION (MI). IN (B)(6) 2011, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASS IB) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 1ST BIFURCATED TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD) WITH 80% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.00X24MM TAXUS ELEMENT STENT USING KISSING BALLOON ANGIOPLASTY. FOLLOWING POST-DILATION USING A 3.0X15MM AND A 3.0X8MM QUANTUM MAVERICK BALLOON, A SMALL RUPTURE WAS OBSERVED IN THE CENTRAL PART OF THE STENT. THIS WAS TREATED WITH PLACEMENT OF A NON-BSC GRAFT MASTER STENT WHICH CAUSED BRANCH OCCLUSION, WITH 0% RESIDUAL STENOSIS. THE SITE CONFIRMED THAT THE SMALL RUPTURE INDICATES CORONARY ARTERY PERFORATION AND IS RELATED TO THE QUANTUM BALLOONS ONLY BUT NOT TO THE STUDY STENT. THE 2ND LONG TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (PROX LCX) EXTENDING INTO THE DISTAL LCX WITH 100% STENOSIS AND WAS 25MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF FOUR TAXUS ELEMENT STENTS OF SIZE 2.50X24MM, 2.50X24MM, 3.00X24MM AND 2.75X12MM AND A 2.25X18MM NON-BSC STENT IN AN OVERLAPPING MANNER, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. POST INDEX PROCEDURE, THE PATIENT EXPERIENCED RECURRENT CHEST PAIN LASTING MORE THAN 20 MINUTES. ELEVATED CARDIAC ENZYME VALUES WERE OBSERVED AND ECG INDICATED A NON Q-WAVE MI. THE PATIENT EXPERIENCED ISCHEMIC SYMPTOMS WITH ST SEGMENT DEPRESSION AS WELL. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126154 TAXUS¿ ELEMENT¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902524250 14031899

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other