BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 741219 · Received July 24, 2006

    Report

    Report Number
    9616099-2006-00781
    Event Type
    Injury
    Date Received
    July 24, 2006
    Date of Event
    June 23, 2006
    Report Date
    July 20, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: DEVICE (LOT# I0506008) IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS RECEIVED FROM THE AFFILIATE. THE TARGET LESION WAS AT THE DISTAL CIRCUMFLEX. THE LESION WAS DE NOVO. THE VESSEL WAS SLIGHTLY CALCIFIED AND NON-TORTUOUS. THE LESION WAS 90% STENOSED. REDIAL APPROACH WAS CHOSEN FOR THE PROCEDURE. PRE-DILATION WAS CONDUCTED WITH A BALLOON CATHETER (OTTIMO ROSSO 1.5X8MM, JLL). THEN WHILE TRYING TO DELIVER THE INITIAL 2.5X18MM CYPHER DES TO THE TARGET LESION, IT BECAME STUCK AT THE PROXIMAL CIRCUMFLEX. THE PROXIMAL CIRCUMFLEX WAS 25% STENOSED, AND THERE WAS SLIGHT CALCIFICATION. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE STENT DELIVERY SYSTEM SLOWLY, BUT THE STENT DISLODGED, AND THE ENTIRE SYSTEM INCLUDING THE GUIDING CATHETER (LAUNCHER 6F AL0.75) AND THE GUIDE WIRE (TGV FLOPPY, GOODMAN) DISENGAGED FROM THE VESSEL. THE DISLODGED STENT WAS FLARED AT THE PROXIMAL END UNDER CAG, THE STENT COULD NOT BE RETRIEVED WITH A SNARE. THEREFORE THE PHYSICIAN DECIDED TO IMPLANT THE DISLODGED STENT AT THE PROXIMAL CIRCUMFLEX. THE GUIDING CATHETER WAS CANNULATED TO THE VESSEL AGAIN, AND THE GUIDE WIRE (TGV FLOPPY, GOODMAN) WAS INSERTED INTO THE STENT AND THE BC (OTTIMO ROSSO 1.5X8, JLL) WAS DELIVERED INTO THE DISLODGED STENT, AND IT WAS DILATED. THEN THE BALLOON WAS CHANGED TO A 2.5MM BALLOON, AND THE STENT WAS DILATED AGAIN. INFLATION DETAILS REMAIN UNKNOWN. THE DISLODGED CYPHER STENT WAS IMPLANTED PROXIMAL TO THE ORIGINALLY PLANNED TARGET LESION. A CYPHER 3.0X18MM WAS IMPLANTED AT THE TARGET LESION. THE CYPHER 2.5X18MM AT THE PROXIMAL CIRCUMFLEX WAS POST-DILATED WITH A 3.0X20MM STENT DELIVERY SYSTEM. INFLATION DETAILS ARE UNK. IVUS WAS CONDUCTED TO CONFIRM THE DEPLOYMENT AND GOOD WALL APPOSITION WAS CONFIRMED, AND THE PROCEDURE FINISHED. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R INFLATION DEVICE: EVEREST| MEDTRONIC| MEDTRONIC| BC: OTTIMO ROSSO 1.5/8MM, JLL| GC: LAUNCHER 6F AL0.75| SHEATH: RADIOFORCUS SHEATH| STENT: CYPHER 2.5/18MM, 3.0/18MM.| TERUMO