BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLASH OSTIAL SYSTEM

    MDR report key: 3142462 · Received September 17, 2013

    Report

    Report Number
    3008700817-2013-00001
    Event Type
    Injury
    Date Received
    September 17, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 6, 2013
    Manufacturer
    OSTIAL CORP.
    Product Code
    LOX
    PMA / PMN Number
    K122178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED BY THE USER FACILITY SO NO INVESTIGATION OF THE DEVICE IN QUESTION WAS POSSIBLE. REVIEW OF THE MANUFACTURING DOCUMENTATION WAS PERFORMED FOR ALL DEVICE LOTS SHIPPED TO THE HOSPITAL THE REPORTING PHYSICIAN WORKS AT AND NO ISSUES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THE DISSECTION. THE INSTRUCTIONS FOR USE FOR THE PRODUCT WAS REVIEWED AND IT WAS VERIFIED THAT DISSECTION IS LISTED AS A POTENTIAL COMPLICATION AND THAT THE INSTRUCTIONS INDICATE THAT THE CATHETER'S DISTAL MARKER BAND SHOULD BE INSIDE OF A STENT WHEN PERFORMING POST DELIVERY STENT DILATION.

    Description of Event or Problem · 1

    AS STATED BY PHYSICIAN: "AFTER PRE-DILATION OF THE CORONARY STENT (BOSTON SCIENTIFIC) WAS DEPLOYED TO TREAT THE RCA-AORTO-OSTIAL LESION. UPON SUBSEQUENT ANALYSIS USING IVUS, IT WAS DETERMINED THE REFERENCE VESSEL SIZE WAS 4.0MM. IDEALLY WE WANTED TO POST-DILATE WITH 4.0MM FLASH OSTIAL SYSTEM (OSTIAL CORPORATION) BUT ONLY HAD A 4.5 MM FLASH ON THE SHELF. WE THEREFORE ATTEMPTED TO FLARE THE AORTO-OSTIAL PART OF THE STENT WITH THE PROMUS BALLOON. DURING POST-DILATION AT THE OSTIUM, THE STENT BECAME DISLODGED, MOVING FROM ITS ORIGINAL DEPLOYED POSITION OF APPROXIMATELY 3-4MM STENT PROTRUDING IN AORTA TO ALMOST 8-9 MM OF THE STENT NOW PROTRUDING INTO THE AORTA. FACING A POTENTIAL SITUATION IN WHICH THE STENT WOULD NEED TO BE SNARED AND REMOVED, WE OPTED TO GO AHEAD AND POST-DILATE USING THE 4.5 MM FLASH OSTIAL SYSTEM." AS STATED BY PHYSICIAN: "BY MANIPULATING THE GUIDE, WE WERE ABLE TO LIFT THE STENT UP AND UNSUCCESSFULLY ADVANCE FLASH SYSTEM INTO THE PROTRUDING STENT. THE DISTAL BALLOON OF THE FLASH SYSTEM WAS FIRST DILATED TO STABILIZE THE POSITIONING OF THE STENT FOLLOWED BY INFLATION OF THE PROXIMAL BALLOON TO EXPAND THE PROTRUDING STRUTS IN CONICAL SHAPE AGAINST THE WALL OF AORTA. DUE TO THE LENGTH OF THE STENT NOW PROTRUDING INTO THE AORTA, ONLY 7-8MM WAS LEFT WITHIN THE RCA DURING DILATION OF THE FLASH SYSTEM. UNAVOIDABLE, THE DISTAL PORTION OF THE 4.5 MM FLASH SYSTEM EXTENDED BEYOND THE DISTAL END OF THE DISLODGED STENT INTO THE 4.0 MM NATIVE VESSEL, RESULTING IN A CONTROLLED DISSECTION WHICH WAS THEN COVERED WITH A SECOND STENT. THE FINAL ANGIOGRAM SHOWED AN EXCELLENT RESULT WHICH WAS ALSO CONFIRMED USING IVUS. THIS WAS A GREAT SAVE. IF WE DID NOT HAVE FLASH OSTIAL SYSTEM, WE MAY HAVE HAD TO SNARE THE STENT, WHICH MIGHT HAVE CAUSE DISSECTION AND A MESH, AND POTENTIALLY EVEN OPEN HEART SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469160 FLASH OSTIAL SYSTEM PTCA CATHETER LOX OSTIAL CORP. OCB4514BA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention