BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ ELEMENT¿

    MDR report key: 2801251 · Received October 23, 2012

    Report

    Report Number
    2134265-2012-06301
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    November 11, 2011
    Report Date
    September 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF BIRTH: 1934. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED 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 MFR ID # 2134265-2012-06299, 2134265-2012-06300. (B)(4) STUDY. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. IN (B)(6) 2011, THE 3.0X15MM 70% STENOSED TARGET LESION WAS LOCATED IN THE FIRST POSTEROLATERAL BRANCH OF THE LEFT CIRCUMFLEX ARTERY (LCX). THE LESION WAS PRE-DILATED AND THE 3.0X20MM TAXUS ELEMENT STENT WAS DEPLOYED USING A KISSING BALLOON TECHNIQUE RESULTING THE 0% RESIDUAL STENOSIS. A SECOND 2.5X15MM, 90% STENOSED TARGET LESION WAS LOCATED IN THE BIFURCATED DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PRE-DILATED AND THE 2.5X20MM TAXUS ELEMENT STENT WAS DEPLOYED USING A KISSING BALLOON TECHNIQUE TOWARDS THE 2ND DIAGONAL RESULTING IN 0% RESIDUAL STENOSIS. THE 2.75X10MM 70% STENOSED PROXIMAL LAD LESION WAS PRE-DILATED AND THE 2.75X16MM TAXUS ELEMENT STENT WAS DEPLOYED RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY ELEVATED TROPONIN LEVELS WERE NOTED. THE PATIENT WAS DISCHARGED SIX DAYS LATER ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2011, THE PATIENT RETURNED DUE TO DYSPNEA AT REST, RAPID AGGRAVATION OF ORTHOPNEA, AND CHEST OPPRESSION. THE 50% STENOSED LESION LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) WAS PRE-DILATED AND A 3.5X24 PROMUS STENT WAS IMPLANTED. POST-DILATION KISSING BALLOON RESULTED IN 0% RESIDUAL STENOSIS. ANGIOGRAPHY REVEALED THAT PREVIOUSLY STENTED LAD LESION WAS "TIGHT" AT THE EXIT OF THE IMPLANTED STENT. THE TIGHT LAD LESION WAS TREATED WITH MEDICATION. FOUR DAYS FOLLOWING THIS PROCEDURE PATIENT EXPERIENCED ELEVATED TROPONIN AND AN MYOCARDIAL INFARCTION. NO ADDITIONAL INTERVENTION WAS REQUIRED AND PATIENT DID NOT EXPERIENCE ISCHEMIC SYMPTOMS. PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ ELEMENT¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902520300 14236217

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention