BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2212241 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03406
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    October 27, 2010
    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
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS 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 REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT WAS MALAPPOSED. USING THE RIGHT FEMORAL APPROACH, THE PROCEDURE TREATED THE DE NOVO, 90% STENOSED AND CONCENTRIC 4.5X6.0MM TARGET LESION LOCATED IN THE OSTIAL OF THE MILDLY CALCIFIED LEFT MAIN ARTERY. THE VESSEL WAS NOT TORTUOUS. PRE-DILATION WAS PERFORMED USING A 2.5X12MM MAVERICK BALLOON INFLATED TO 14 ATM'S AND A 3.5X6.0MM FLEXTOME CUTTING BALLOON INFLATED TO 14 ATM'S. IVUS WAS THEN PERFORMED NOTING A SEVERE FOCAL LESION IN THE OSTIAL OF THE LEFT MAIN ARTERY. A 4.0X12MM TAXUS ELEMENT STENT WAS PLACED HANGING DOWN THE AORTA, AND DEPLOYED AT 20 ATM'S. IT WAS NOTED THAT THE STENT WAS MALAPPOSED. IVUS WAS AGAIN PERFORMED, CONFIRMING THE DISTAL PORTION OF THE STENT WAS MALAPPOSED. POST DILATION WAS PERFORMED USING A 5.0X10MM NON BSC, NON COMPLIANT BALLOON INFLATED TO 24 ATMS AND FORESHORTENING OF THE PROXIMAL PORTION OF THE STENT WAS NOTED. ADDITIONAL POST DILATION WITH A 5.0MM NON COMPLIANT BALLOON WAS PERFORMED. AN ADDITIONAL STENT WAS REQUIRED TO COVER THE TARGET LESION AND A 4.0X9.0MM NON BSC STENT WAS DEPLOYED AT 22 ATM'S RESULTING IN 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902512400 13656849

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 2.5X12MM MAVERICK BALLOON| 3.5X6.0MM FLEXTOME CUTTING BALLOON| 5.0X10MM HYRIU BALLOON| BMW GUIDE WIRE