BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXPRESS2 OTW CORONARY STENT DELIVERY SYSTEM

    MDR report key: 519022 · Received April 2, 2004

    Report

    Report Number
    6000093-2004-00117
    Event Type
    Death
    Date Received
    April 2, 2004
    Date of Event
    March 5, 2004
    Report Date
    March 5, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT DISLODGED FROM THE DELIVERY DEVICE. THE PHYSICIAN WAS ATTEMPTING TO DELIVER AN EXPRESS 4.0 X 28 MM CORONARY STENT TO A LESION IN A SVG TO THE CIRCUMFLEX. THE PHYSICIAN WAS EXPERIENCING DIFFICULTY CROSSING THE LESION WHEN THE WIRE AND THE STENT FLIPPED OUT INTO THE AORTA. WHEN THE STENT DELIVERY CATHETER WAS REMOVED FROM THE GUIDE CATHETER, THE STENT WAS NOT ON THE DELIVERY DEVICE. THE STENT WAS NOT LOCATED. THE PHYSICIAN PROCEEDED TO PERFORM INTERVENTION IN A SVG TO THE RCA, WHEN A PERFORATION OCCURRED. THE PT SUBSEQUENTLY EXPIRED. IT WAS REPORTED THAT THERE WAS NO PRODUCT PROBLEM; THE STENT TO THE SVG-RGA GRAFT MAY HAVE BEEN OVERSIZED. THE PT'S DEATH WAS DUE TO THE PERFORATION OF THE RCA-SVG GRAFT FOLLOWING PLACEMENT OF A STENT, AND DOES NOT APPEAR TO BE RELATED TO THE EXPRESS2 4.0 X 28 MM STENT DISLODGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 OTW CORONARY STENT DELIVERY SYSTEM PREMOUNTED BALLOON EXPANDABLE STENT SYSTEM MAF BOSTON SCIENTIFIC H7493507028400 6202635

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death