BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ ELEMENT¿

    MDR report key: 2212104 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03452
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    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)(4). 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

    (B)(4). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE A STENT MIGRATION OCCURRED. THE TARGET LESION WAS A BIFURCATED LESION LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) WITH 60% STENOSIS AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND AN ATTEMPT TO IMPLANT A 3.5 X 8 MM TAXUS ELEMENT STENT WHICH WAS UNSUCCESSFUL. WHILE ATTEMPTING TO IMPLANT THE STENT, IT "IMPACTED BADLEY ON THE LMCA AND HAS MIGRATED INTO THE AORTA". A 3.5 X 12 MM TAXUS ELEMENT STENT WAS SUCCESSFULLY IMPLANTED IN THE LESION AND FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PHYSICIAN HAS STATED, "THAT THE FIRST STENT WAS TOO SMALL SO IT MIGRATED BUT THEY MANAGED TO RETRIEVE IT OUT OF THE PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ ELEMENT¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902508350 13701840

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention