BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2162680 · Received July 14, 2011

    Report

    Report Number
    9616099-2011-00483
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 15, 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

    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 A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PHYSICIAN EXPERIENCED TRACKING DIFFICULTY WHILE ADVANCING THE CYPHER SELECT PLUS 2.5 X 13 MM STENT DELIVERY SYSTEM (SDS) TO THE INTENDED TARGET LESION. THE PHYSICIAN WAS NOT ABLE TO REACH THE LESION. THE TRACKING DIFFICULTY WAS REPORTED TO BE DUE TO MODERATE FLEXION OF THE TARGET VESSEL AT THE LEVEL OF THE MID TO DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN REMOVED THE DEVICE/SDS SUCCESSFULLY FROM THE PATIENT. AN ENDEAVOR STENT WAS USED/SUCCESSFULLY IMPLANTED AT THE TARGET LESION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION FOR THE PROCEDURE WAS THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA). THE LESION WAS REPORTED TO BE: DE NOVO, MODERATELY CALCIFIED/TORTUOUS, AND A 90% STENOSIS. IT WAS NOT KNOWN IF THE LESION WAS PRE-DILATED. PRELIMINARY INSPECTION OF THE RETURNED PRODUCT INDICATED THAT THE PROXIMAL STENT STRUTS WERE UPLIFTED. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON-STERILE CYPHER BX (B)(4) 2.50 X 13 MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE STENT WAS MOUNTED IN ITS ORIGINAL POSITION BETWEEN MARKER BANDS; STRUTS UPLIFT WAS OBSERVED IN PROXIMAL SECTION OF THE STENT. SDS DID NOT SHOW ANY DAMAGE. CROSSING PROFILE WAS MEASURED FOR DISTAL AND MIDDLE SECTIONS OF THE STENT AND WAS FOUND WITHIN SPECIFICATION. THE PROXIMAL AREA WAS NOT MEASURE DUE TO THE OBSERVED DAMAGE. DURING MICROSCOPIC ANALYSIS THE STRUTS AT DISTAL AREA WAS UPLIFTED; NO OTHER DAMAGES WERE OBSERVED. 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. THE REPORTED FAILURE "TRACKING DIFFICULTY" COULD NOT BE CONFIRMED AND THE OTHER FAILURE REPORTED "STRUT UPLIFT" WAS CONFIRMED SINCE STRUTS UPLIFT WERE OBSERVED IN 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. DIFFICULTY TRACKING A PRODUCT THROUGH 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. TRACKING DIFFICULTY IS MOST COMMONLY RELATED TO THE PATIENT'S ANATOMY, VESSEL CHARACTERISTICS, OPERATOR'S TECHNIQUE AND APPROPRIATE DEVICE SELECTION. 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 DELIVER THE STENT TO THE TARGET LESION. BASED ON THE INFORMATION AVAILABLE THERE ARE POSSIBLE VESSEL CHARACTERISTICS (MODERATE FLEXION OF THE TARGET VESSEL) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. NEITHER THE DHR NOR THE PRODUCT ANALYSIS SUGGEST 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 A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PHYSICIAN EXPERIENCED TRACKING DIFFICULTY WHILE ADVANCING THE CYPHER SELECT PLUS 2.5 X 13 MM STENT DELIVERY SYSTEM (SDS) TO THE INTENDED TARGET LESION. THE PHYSICIAN WAS NOT ABLE TO REACH THE LESION. THE TRACKING DIFFICULTY WAS REPORTED TO BE DUE TO MODERATE FLEXION OF THE TARGET VESSEL AT THE LEVEL OF THE MID TO DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN REMOVED THE DEVICE/SDS SUCCESSFULLY FROM THE PATIENT. AN ENDEAVOR STENT WAS USED/SUCCESSFULLY IMPLANTED AT THE TARGET LESION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION FOR THE PROCEDURE WAS THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA). THE LESION WAS REPORTED TO BE: DE NOVO, MODERATELY CALCIFIED/TORTUOUS, AND A 90% STENOSIS. IT WAS NOT KNOWN IF THE LESION WAS PRE-DILATED. PRELIMINARY INSPECTION OF THE RETURNED PRODUCT INDICATED THAT THE PROXIMAL STENT STRUTS WERE UPLIFTED.

    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 15068231

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR STENT: ENDEAVOR