BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ ELEMENT¿

    MDR report key: 2253498 · Received September 19, 2011

    Report

    Report Number
    2134265-2011-04145
    Event Type
    Injury
    Date Received
    September 19, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). 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

    IT WAS FURTHER REPORTED THAT THE SITE HAS CHANGED THEIR ASSESSMENT OF DEVICE RELATIONSHIP TO UNRELATED.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 80% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT OF A 3.0 X 32 MM TAXUS ELEMENT STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2011, POST INDEX PROCEDURE, THE SUBJECT HAD ELEVATED TROPONIN VALUES AND AN MI WAS REPORTED. NO ACTION WAS TAKEN TO TREAT THIS EVENT AND THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ ELEMENT¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902532300 14234185

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other