BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODIVYSIO 3.5 X 15MM STENT

    MDR report key: 364998 · Received December 5, 2001

    Report

    Report Number
    6000117-2001-00010
    Event Type
    Injury
    Date Received
    December 5, 2001
    Date of Event
    November 5, 2001
    Report Date
    November 5, 2001
    Manufacturer
    BIOCOMPATIBLES LTD
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO PLACE A 3.5 X 15MM BIODIVYSIO STENT IN THE MID-RIGHT CORONARY ARTERY WITH 70% STENOSIS. THE PHYSICIAN ATTEMPTED TO CROSS THE CALCIFIED LESION, BUT WAS UNSUCCESSFUL. HE SUCCESSFULLY REMOVED THE STENT. AFTER ANOTHER PRE-DILATATION, HE TRIED TO CROSS THE LESION AGAIN WITH THE SAME STENT. HE WAS UNSUCCESSFUL AGAIN, SO HE TRIED TO REMOVE THE SYSTEM. THE STENT BECAME DISLODGED, AND WAS IN THE PROXIMAL RIGHT CORONARY ARTERY. AFTER UNSUCCESSFUL SNARE ATTEMPTS, HE PLACED ANOTHER WIRE AND WAS ABLE TO GET A NIR ROYAL STENT NEXT TO THE BD STENT. HE INFLATED THE NIR AND PINCHED THE UNDEPLOYED BD STENT BETWEEN THE DEPLOYED NIR AND THE VESSEL WALL. THE BALLOON CATHETER WAS A 3.5 MAV; GUIDING CATHETER WAS AJR4; THE GUIDEWIRE WAS A BMW. THE VESSEL SIZE WAS 3.5 AND WAS NOT TORTUOUS, BUT THE LESION WAS EXCESSIVELY CALCIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54614 BIODIVYSIO 3.5 X 15MM STENT CORONARY STENT MAF BIOCOMPATIBLES LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention GUIDING CATHETER, BMW GUIDEWIRE.| NIR ROYAL STENT, 3.5 MAV BALLOON CATHETER, JR4