BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1883696 · Received October 27, 2010

    Report

    Report Number
    3003742446-2010-00379
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 30, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DURING A PCI, A CYPHER STENT DISLODGED DURING WITHDRAWAL AFTER IT FAILED TO CROSS A CALCIFIED LESION IN THE PROXIMAL PORTION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.25 X 13MM CYPHER STENT CAME OFF OF THE BALLOON IN THE LAD WHILE PULLING THE PRODUCT BACK AS THEY COULD NOT CROSS THE CALCIFIED LESION. THE STENT WAS SUCCESSFULLY RETRIEVED WITH A SNARE. ADDITIONAL INFORMATION INDICATED THAT THERE WERE NO ANOMALIES NOTED PRIOR TO USE AND THE PRODUCT PREPPED PROPERLY. THE STENT WAS NOT MANIPULATED IN ANY WAY DURING THE PREPARATION OF THE PRODUCT. NEGATIVE PREP WAS DONE OUTSIDE THE BODY BEFORE USE. THE IFU INDICATES TO NOT INDUCE A NEGATIVE PRESSURE ON THE DELIVERY CATHETER BEFORE PLACEMENT OF THE STENT ACROSS THE LESION. THIS MAY CAUSE PREMATURE DISLODGEMENT OF THE STENT FROM THE BALLOON. IT WAS NOTED THAT THE LESION WAS DIFFICULT TO WIRE AND THERE WAS RESISTANCE MET DURING ADVANCEMENT OF THE SDS DESCRIBED AS "MUCH PUSHING OF THE PRODUCT WAS CONDUCTED TO GET IT TO CROSS THE LESION" DUE TO THE CALCIFICATION. SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE SDS PRE-STENT IMPLANTATION, THE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. WHEN REMOVING THE SDS AS A SINGLE UNIT, DO NOT RETRACT THE DELIVERY SYSTEM INTO THE GUIDING CATHETER OR SHEATH. FAILURE TO FOLLOW STENT/SDS REMOVAL INSTRUCTIONS AND/OR APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR SDS COMPONENTS. THE PRODUCT WAS REMOVED BY PULLING BACK INTO THE GUIDING CATHETER IN ORDER TO EXCHANGE FOR PRE-DILATION BALLOON. THE BALLOON DISLODGED WHILE PULLING THE PRODUCT BACK AFTER FAILED ATTEMPTS TO CROSS THE LESION BUT BEFORE IT WAS PULLED BACK INTO THE GUIDING CATHETER FOR REMOVAL. THE LESION WAS LEFT UNTREATED AT THIS SETTING. THE PATIENT DIDN'T SUFFER ANY INJURY. THE SDS WAS DISCARDED AND THE PRODUCT WAS NOT RETURNED FOR EVALUATION. HOWEVER, A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF THIS LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DISLODGED STENT FAILURE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED WITHOUT A PRODUCT RETURN. DIFFICULTY CROSSING A LESION OR AN ANATOMICAL STRUCTURE IS A KNOWN PROCEDURAL OCCURRENCE. THIS TYPE OF DIFFICULTY OCCURRING DURING THE CLINICAL USE OF THE DEVICE IS 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. BASED ON THE INFORMATION AVAILABLE THERE ARE POSSIBLE VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A BMW GUIDEWIRE AND A 6F SHEATH INTRODUCER WERE USED DURING THE INDEX PROCEDURE. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ADDITIONAL TESTING. THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. HOWEVER, A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF THIS LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR A PROCEDURE WITH A CALCIFIED LESION IN THE PROXIMAL PORTION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS NOTED THAT THE 2.25 X 13MM CYPHER STENT CAME OFF OF THE BALLOON IN THE LAD, WHILE PULLING THE PRODUCT BACK AS THEY COULD NOT CROSS THE CALCIUM. THE STENT WAS SUCCESSFULLY RETRIEVED WITH A SNARE. THERE WERE NO ANOMALIES NOTED PRIOR TO USE AND THE PRODUCT PREPPED PROPERLY. THE STENT WAS NOT MANIPULATED IN ANY WAY DURING THE PREPARATION OF THE PRODUCT. IT WAS NOTED THAT THE LESION WAS DIFFICULT TO WIRE AND THE STENT HAD TO PASS THROUGH CALCIUM.

    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) 15201940

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention