BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1873127 · Received October 18, 2010

    Report

    Report Number
    3003742446-2010-00367
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 23, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), A CYPHER STENT DISLODGED AFTER IT FAILED ATTEMPTS TO CROSS A LESION AND THE STENT WAS FINALLY DEPLOYED AT AN UNINTENDED TARGET SITE. THE PHYSICIAN WAS NOT ABLE TO CROSS/ACCESS THE DISTAL OBTUSE MARGINAL (OM) TARGET LESION WITH THE CYPHER 2.25 X 23 MM STENT AND THE STENT DISLODGED. THE OM TARGET LESION WAS REPORTED TO BE: CALCIFIED AND ANGULATED. THE PHYSICIAN WAS ABLE TO RE-CROSS INTO THE STENT USING A 2.0 X 10 MM APEX BALLOON CATHETER AND HE IMPLANTED THE STENT IN THE PROXIMAL CIRCUMFLEX, NON-TARGET SITE. THE PHYSICIAN THEN USED A NON-CORDIS BARE METAL STENT TO SUCCESSFULLY TREAT THE INTENDED TARGET LESION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. DIFFICULTY CROSSING A LESION OR AN ANATOMICAL STRUCTURE IS A KNOWN PROCEDURAL OCCURRENCE. THESE TYPES OF DIFFICULTIES OCCURRING DURING THE CLINICAL USE OF THE DEVICE ARE USUALLY ADDRESSED BY MODIFICATION IN TECHNIQUE OR SUBSTITUTION WITH ANOTHER DEVICE. CROSSING DIFFICULTY IS MOST COMMONLY RELATED TO THE PATIENT'S ANATOMY, VESSEL CHARACTERISTICS, OPERATOR'S TECHNIQUE AND APPROPRIATE DEVICE SELECTION. THE RELATIONSHIP BETWEEN THE FAILURE TO CROSS OR TRACK A PRODUCT AND THE PRODUCT ITSELF IS NOT CLEAR, BUT FACTORS SUCH AS TORTUOUS VESSELS, CALCIFIED LESIONS OR AN INCREASED DIFFICULTY TO TRACK THE PRODUCT THROUGH AN EXISTING STENT MAY CONTRIBUTE TO IT. THE STENT DISLODGEMENT MAY BE ATTRIBUTED TO THE OPERATOR'S ATTEMPTS TO CROSS THE LESION. BASED ON THE INFORMATION AVAILABLE THERE ARE POSSIBLE VESSEL CHARACTERISTICS (CALCIFIED AND ANGULATED) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PHYSICIAN WAS NOT ABLE TO CROSS/ACCESS THE DISTAL OBTUSE MARGINAL (OM) TARGET LESION WITH THE CYPHER 2.25 X 23 MM STENT AND THE STENT DISLODGED. THE PHYSICIAN WAS ABLE TO RE-CROSS INTO THE STENT USING A 2.0 X 10 MM APEX BALLOON CATHETER AND HE IMPLANTED THE STENT IN THE PROXIMAL CIRCUMFLEX. THE PHYSICIAN THEN USED A NON-CORDIS BARE METAL STENT TO SUCCESSFULLY TREAT THE INTENDED TARGET LESION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE OM TARGET LESION WAS REPORTED TO BE: CALCIFIED AND ANGULATED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) 15201942

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R