BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1834216 · Received September 14, 2010

    Report

    Report Number
    9616099-2010-00690
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CYPHER SELECT PLUS PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES, HOWEVER IT IS SIMILAR TO THE CYPHER SIROLIMUS-ELUTING CORONARY STENT PRODUCT DISTRIBUTED IN THE UNITED STATES. DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OF THE RIGHT CORONARY ARTERY (RCA) THE CYPHER SELECT + 3.50X28MM SHAFT WAS BROKEN INTO TWO HALVES WHILE TRACKING THROUGH A MEDTRONIC AL-3 GUIDE CATHETER. THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE TRACKING THE CYPHER PRODUCT THROUGH THE GUIDE CATHETER AND UPON WITHDRAWAL, THE SHAFT BROKE IN TWO PIECES INSIDE THE GUIDE CATHETER. THE PHYSICIAN REMOVED THE TWO PIECES AND THE GUIDING CATHETER FROM THE PATIENT WITHOUT DIFFICULTY AND A DIFFERENT CYPHER WAS USED TO FINISH THE PROCEDURE SUCCESSFULLY. THERE WAS NO DAMAGE NOTED ON THE PRODUCT PRIOR TO REMOVAL FROM ITS PACKAGING. THE SDS WAS PREPPED ACCORDING TO IFU. THE STENT APPEARED NORMAL BEFORE INSERTING INTO THE PATIENT. THE REPORTER INDICATED THAT NO EXCESSIVE FORCE WAS APPLIED WHILE INSERTING OR WITHDRAWING THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WAS RETURNED FOR EVALUATION. ONE NON-STERILE CYPHER SELECT+ 3.50 X 28 WAS RECEIVED BROKEN IN TWO PIECES INSIDE A PLASTIC BAG. THERE WERE KINKS AND BENTS DETECTED ON THE SDS. THE SHAFT OF THE STENT DELIVERY SYSTEM WAS BROKEN AT 69 CM FROM THE PROXIMAL END. THE EDGES OF THE BROKEN SECTION OF THE SDS APPEARED AS IF IT WAS KINKED BEFORE IT GOT BROKEN. THE CROSSING PROFILE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. INSERTION/WITHDRAWAL FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED BECAUSE PRODUCT WAS BROKEN IN TWO PIECES. 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 BY CUSTOMER COMPLAINT AS SHAFT-SEPARATED WAS CONFIRMED. THE FAILURE REPORTED AS SDS-RESISTANCE/FRICTION WAS NOT CONFIRMED AS THE GUIDE CATHETER USED IN THE PROCEDURE WAS NOT RETURNED WITH COMPLAINT PRODUCT. THE CAUSE OF THE REPORTED FAILURES, KINKS AND BENTS COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE PRODUCT ANALYSIS NOR THE DHR SUGGEST THAT THE REPORTED FAILURES AND SDS DAMAGES COULD POTENTIALLY BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. BASED ON THE INFORMATION PROVIDED, THERE ARE POSSIBLE PROCEDURAL FACTORS, SUCH AS EFFORTS MADE AS RESISTANCE WAS FELT INSERTING CYPHER PRODUCT INSIDE THE GUIDE CATHETER THAT MAY HAVE CONTRIBUTED TO THE KINKS FOUND RESULTING IN SHAFT SEPARATION.

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE A MEDTRONIC AL-3 GUIDE CATHETER, BMW WIRE AND A 6F MEDTRONIC SHEATH WERE USED. THE CYPHER SELECT PLUS PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES, HOWEVER IT IS SIMILAR TO THE CYPHER SIROLIMUS-ELUTING CORONARY STENT PRODUCT DISTRIBUTED IN THE UNITED STATES. 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 LOT 15097651 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OF THE RIGHT CORONARY ARTERY (RCA) THE CYPHER SELECT + 3.50X28MM SHAFT WAS BROKEN INTO TWO HALVES WHILE TRACKING THROUGH A MEDTRONIC AL-3 GUIDE CATHETER. THERE WAS RESISTANCE WHILE TRACKING THROUGH THE GUIDE CATHETER. INFLATION WAS ACHIEVED AND ATTEMPTED, BUT THEY DIDN'T TAKE THE STENT INTO THE PATIENT. WHEN THEY PULLED BACK FROM THE GUIDE CATHETER THE STENT SHAFT WAS NOTICED BROKEN INTO 2 HALVES INSIDE THE GUIDE CATHETER ITSELF. THE PHYSICIAN RETRIEVED THE CYPHER STENT BACK AND USED ANOTHER DIFFERENT SIZE CYPHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NOTHING HAPPENED TO THE PATIENT. THERE WAS NO DAMAGE NOTED ON THE PRODUCT PRIOR TO REMOVAL FROM ITS PACKAGING. THE SDS WAS PREPPED ACCORDING TO IFU. THE STENT APPEARED NORMAL BEFORE INSERTING INTO THE PATIENT. THE VESSEL WAS PRE-DILATED AT NOMINAL PRESSURE. THERE WAS NO EXCESSIVE FORCE WAS APPLIED WHILE INSERTING OR WITHDRAWING THE DEVICE.

    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 15097651

    Patients

    Seq Age Sex Outcome Treatment
    1