BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2033571 · Received March 30, 2011

    Report

    Report Number
    9616099-2011-00211
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 4, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFLATION DEVICE: SHEENMAN; GW: FIELDER; GC: MACH1; BC: VOYAGER; SHEATH: TERUMO.THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING AN ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI) AFTER PRE-DILATION WITH A VOYAGER BALLOON CATHETER, THE PHYSICIAN HAD DIFFICULTY ADVANCING/TRACKING THE CYPHER 2.5 X 23 MM STENT DELIVERY SYSTEM (SDS) TO THE DISTAL CIRCUMFLEX TARGET LESION AND IT BECAME STUCK. THE PHYSICIAN REMOVED THE CYPHER SDS FROM THE PATIENT AND PRE-DILATED THE LESION SEVERAL MORE TIMES. THE PHYSICIAN THEN ATTEMPTED TO ACCESS/CROSS THE TARGET LESION AGAIN, BUT WAS STILL NOT SUCCESSFUL. THE PHYSICIAN THEN REMOVED THE CYPHER SDS AGAIN AND UPON EXAMINATION NOTED THAT THE STENT STRUTS WERE UPLIFTED. THE PHYSICIAN THEN USED A XIENCE STENT TO TREAT THE TARGET LESION AND COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE DISTAL CIRCUMFLEX TARGET LESION WAS REPORTED TO BE: DE NOVO, MODERATELY CALCIFIED/TORTUOUS, AND A 90% STENOSIS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT IS NOT KNOWN IF THE PRODUCT WAS REMOVED BY PULLING IT BACK INTO THE GUIDE CATHETER OF AS A SINGLE UNIT WITH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY EXPERIENCED REMOVING THE DEVICE AND IT WAS UNKNOWN IF THE STENT STRUT UPLIFT OCCURRED DURING WITHDRAWAL FROM THE VESSEL, THROUGH THE GC, OR THE CSI. THE REPORTER INDICATED THAT THERE NO ABNORMALITIES NOTED DURING INSPECTION OR PREPARATION OF THE DEVICE FOR USE. THE USER PREPARED THE DEVICE ACCORDING TO THE IFU INSTRUCTIONS. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON-STERILE CYPHER BX (B)(4) 2.50 MM X 25 MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE STENT WAS RECEIVED CRUSHED MOUNTED BETWEEN MARKER BANDS. STENT STRUT UPLIFT WAS OBSERVED IN THE PROXIMAL END. SDS DID NOT SHOW ANY DAMAGE. A CROSSING PROFILE OF THE STENT COULD NOT BE MEASURE DUE TO THE RECEIVED CONDITION OF THE STENT. 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. "STRUT UPLIFT" WAS CONFIRMED SINCE STRUT UPLIFT WAS OBSERVED IN THE PROXIMAL END DURING ANALYSIS. THE EXACT CAUSE OF THE FAILURES REPORTED BY THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED. IT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS; CONTROLS ARE IN PLACE TO PREVENT DAMAGED UNITS LEAVE THE FACILITY, (B)(4). THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN. DIFFICULTY CROSSING AND TRACKING A LESION OF 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 UPLIFTED STRUTS MAY BE ATTRIBUTED TO THE OPERATOR'S ATTEMPT TO CROSS A HIGHLY CALCIFIED AND TORTUOUS LESION AND/OR DURING REMOVAL OF THE PRODUCT FROM THE PATIENT. BASED ON THE INFORMATION AVAILABLE, THERE ARE POSSIBLE VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. NEITHER THE FAL REPORT, NOR THE INFORMATION AVAILABLE FOR REVIEW, INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING AN ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI) AFTER PRE-DILATION WITH A VOYAGER BALLOON CATHETER, THE PHYSICIAN HAD DIFFICULTY ADVANCING/TRACKING THE CYPHER 2.5 X 23 MM STENT DELIVERY SYSTEM (SDS) TO THE DISTAL CIRCUMFLEX TARGET LESION AND IT BECAME STUCK. THE PHYSICIAN REMOVED THE CYPHER SDS FROM THE PATIENT AND PRE-DILATED THE LESION SEVERAL MORE TIMES. THE PHYSICIAN THEN ATTEMPTED TO ACCESS/CROSS THE TARGET LESION AGAIN BUT WAS STILL NOT SUCCESSFUL. THE PHYSICIAN THEN REMOVED THE CYPHER SDS AGAIN AND UPON EXAMINATION NOTED THAT THE STENT STRUTS WERE UPLIFTED. THE PHYSICIAN THEN USED A XIENCE STENT TO TREAT THE TARGET LESION AND COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE DISTAL CIRCUMFLEX TARGET LESION WAS REPORTED TO BE: DE NOVO, MODERATELY CALCIFIED/TORTUOUS, AND A 90% STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 15071062

    Patients

    Seq Age Sex Outcome Treatment
    1