BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1940402 · Received December 29, 2010

    Report

    Report Number
    3003742446-2010-00497
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 3, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION, BUT THE ANALYSIS IS NOT YET COMPLETE.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING PERCUTANEOUS CORONARY INTERVENTION (PCI), THE SHAFT OF A CYPHER STENT DELIVERY SYSTEM BROKE DURING DELIVERY TO THE TARGET LESION. THE PRODUCT WAS REMOVED AND THE EVENT RESOLVED WITHOUT SEQUEL. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING (LAD) AT THE BIFURCATION WITH THE FIRST DIAGONAL BRANCH WITH 90% STENOSIS. THERE WAS AN UNKNOWN PATENT STENT IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A BMW WIRE WAS PASSED INTO THE DISTAL DIAGONAL AND A TERUMO RUN THROUGH WIRE WAS PASSED INTO THE DISTAL LAD. THEN, A SPRINTER 2.5X15MM BALLOON WAS PASSED OVER THE BMW WIRE INTO THE DIAGONAL BEYOND THE LAD BIFURCATION AND A 2.50X28MM CYPHER STENT WAS INITIALLY ATTEMPTED BUT THERE WAS A FRACTURE IN THE SHAFT. THE CYPHER STENT WAS REMOVED AND A 2.5X28MM XIENCE STENT WAS IMPLANTED USING THE BALLOON/STENT KISSING TECHNIQUE WITH GOOD ANGIOGRAPHIC RESULTS. TIMI III FLOW WAS REPORTED. ONE NON-STERILE UNIT OF CYPHER US RX 2.50 X 28 WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE STENT WAS RECEIVED AT THE CORRECT POSITION WITHOUT VISUAL DAMAGE. A TWISTED CONDITION WAS NOTED AT 17.9CM FROM DISTAL TIP. TWO KINKS WERE OBSERVED AT 29.6CM AND 30.8CM FROM DISTAL TIP. NO OTHER VISUAL ANOMALIES WERE OBSERVED ON THE RECEIVED UNIT. THE BODY/SHAFT WAS OBSERVED UNDER MICROSCOPE AND NO OTHER ANOMALY WAS FOUND BESIDES THE DAMAGES NOTED DURING VISUAL ANALYSIS. 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 THE CUSTOMER AS "BODY/SHAFT- SEPARATED-IN PATIENT" WAS NOT CONFIRMED DURING ANALYSIS; HOWEVER THE DEVICE PRESENTED DAMAGES ALONG OF THE BODY/SHAFT. THE EXACT CAUSE FOR THE DAMAGES FOUND DO NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS AND NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE POSSIBLE PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE DAMAGES FOUND IN THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    THE SHAFT OF THE CYPHER US RX 2.50 X 28MM WAS FRACTURED. THEREFORE, IT WAS NOT POSSIBLE TO DEPLOY. THE PRODUCT WAS USED IN THE PATIENT. THERE WAS NO PATIENT INJURY. THE PRODUCT HAS BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    CARDIAC CATHETERIZATION REPORT CONFIRMED THE MID LEFT ANTERIOR DESCENDING (LAD) HAD 90% STENOSIS AFTER THE DIAGONAL TAKEOFF, BUT AT DIAGONAL TAKEOFF ITSELF. THE LAD HAD 70% STENOSIS, THE LEFT CIRCUMFLEX HAD 20% DISEASE PROXIMALLY, AND THE OBTUSE MARGINAL HAD 20-50% STENOSIS. THERE WAS 20% DISEASE PROXIMALLY AND 20% IN THE MID SEGMENT OF THE RCA. THERE WAS AN UNKNOWN PATENT STENT IN THE DISTAL RCA. THERE WAS SPASM NOTED DURING THE PROCEDURE WHICH WAS RESOLVED WITH NITROGLYCERIN. DURING THE PROCEDURE, AN INITIAL ATTEMPT WAS MADE TO IMPLANT THE 2.50X28MM CYPHER STENT. HOWEVER, THERE WAS A FRACTURE IN THE SHAFT OF THE CYPHER STENT. THE CYPHER STENT WAS REMOVED AND A XIENCE STENT WAS IMPLANTED. ANGIOGRAPHY SHOWED GOOD RESULTS IN THE XIENCE STENT ITSELF; HOWEVER, THE DIAGONAL HAD SOME DISEASE AT ITS TAKEOFF SO BALLOON ANGIOPLASTY WAS PERFORMED IN THE BIFURCATION OF THE DIAGONAL LESION. THERE WERE NO COMPLICATIONS AND NO EVIDENCE OF A DISSECTION. THERE WAS TIMI GRADE 3 FLOW DISTALLY.

    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) NA 15243438

    Patients

    Seq Age Sex Outcome Treatment
    1