BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1220416 · Received October 31, 2008

    Report

    Report Number
    9616099-2008-02586
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THE PHYSICIAN EXPERIENCED TRACKING DIFFICULTY WHEN ADVANCING THE STENT DELIVERY SYSTEM (SDS) OVER THE GUIDEWIRE. THE SDS WAS REMOVED FROM THE PATIENT. THERE WERE NO PATIENT DEMOGRAPHICS AVAILABLE. THE TARGET LESION WAS LAD (LEFT ANTERIOR DESCENDING ARTERY) DESCRIBED AS CALCIFIED. THE RATE OF STENOSIS WAS NOT REPORTED. THE LESION WAS EASILY ACCESSED BY THE INTERVENTIONAL GUIDEWIRE; THE LESION WAS PREDILATED WITHOUT REPORTED DIFFICULTIES. THE CYPHER WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED. WHEN THE PHYSICIAN TRIED TO NEGOTIATE THE STENT TO THE TARGET LESION, HE FELT RESISTANCE WITHIN THE LAD. ANOTHER COMPETITOR'S PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY FOR THE PATIENT. ONE NON-STERILE 2.75MM X 23MM CYPHER WAS RECEIVED COILED INSIDE OF A PLASTIC BAG FOR ANALYSIS. THE SHAFT WAS KINKED AT 64CM, 124.7CM, AND 134.5CM FROM THE PROXIMAL END. THE STENT WAS FLARED AND BENT AT THE PROXIMAL EDGE. THE STENT CROSSING PROFILE WAS PERFORMED TO THE MIDDLE AND PROXIMAL SECTIONS TO THE RETURNED CYPHER DUE TO DAMAGE CONDITION OF THE STENT DISTAL SECTION, AND WAS FOUND WITHIN SPECIFICATION ACCORDING TO MQP. 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 SDS TRACKING DIFFICULTY FAILURE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THE CAUSE OF FLARED STENT AND KINKED SHAFT FAILURES COULD NOT BE CONCLUSIVELY DETERMINED. PROCEDURAL FACTORS MIGHT HAVE CONTRIBUTED TO THE FAILURE EXPERIENCED BY THE CUSTOMER. NEITHER THE STENT CROSSING PROFILE NOR THE DHR REVIEW RESULTS SUGGEST THAT THE FAILURES ABOVE MENTIONED ARE RELATED TO THE MANUFACTURING PROCESS. NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE COMPLAINT OF TRACKING DIFFICULTY COULD NOT BE CONFIRMED. THE COMPLAINT OF STRUT UPLIFT WAS CONFIRMED DURING ANALYSIS OF THE PRODUCT. ADDITIONAL DAMAGE TO THE SDS WAS NOTED ON ANALYSIS THAT WAS NOT IDENTIFIED IN THE REPORTED COMPLAINT; I.E. THE MULTIPLE KINKS IN THE CATHETER SHAFT. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY. REVIEW OF THE INFORMATION AVAILABLE SUGGESTS THAT PROCEDURAL AND VESSEL FACTORS MAY HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE ORIGINAL COMPLAINT RECEIVED STATES THE PHYSICIAN EXPERIENCED TRACKING DIFFICULTY WHEN ADVANCING THE STENT DELIVERY SYSTEM (SDS) OVER THE GUIDEWIRE. THE SDS WAS REMOVED FROM THE PATIENT. ANOTHER COMPETITOR'S PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING AND IT WAS FOUND THAT THE STENT WAS FLARED AND BENT AT THE PROXIMAL EDGE. THE PATIENT IS A 70 YEAR-OLD FEMALE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET LESION WAS LAD (LEFT ANTERIOR DESCENDING ARTERY) DESCRIBED AS CALCIFIED. THE RATE OF STENOSIS WAS NOT REPORTED. THE LESION WAS EASILY ACCESSED BY THE INTERVENTIONAL GUIDEWIRE; THE LESION WAS PRE-DILATED WITHOUT REPORTED DIFFICULTIES. THE CYPHER WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED. WHEN THE PHYSICIAN TRIED TO NEGOTIATE THE STENT TO THE TARGET LESION, HE FELT RESISTANCE WITHIN THE LAD. ANOTHER COMPETITOR'S PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY FOR THE PATIENT.

    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 13434859

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR GOODMAN (2.0X15)| BMW (GDT)