BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1840257 · Received September 21, 2010

    Report

    Report Number
    9616099-2010-00708
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 28, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS USED DURING THE PROCEDURE WERE: INFLATION DEVICE: SHEEN MAN'S, GW: ROUTE, RINATO, X-TREME, GC: LAUNCHER, BC: LACROSSE HIRYU, SHEATH: TERUMO'S. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ADDITIONAL TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS (B)(4) CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT.

    Additional Manufacturer Narrative · 1

    THIS (B)(4) CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. DURING A PCI, A CYPHER STENT HAD TRACKING DIFFICULTY AND THE STENT WAS NOTED TO BE OFFSET OUT OF POSITION UPON REMOVAL. THEN, CYPHER SELECT+ (2.75/23MM) WAS INSERTED TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA), BUT IT COULD NOT BE DELIVERED DUE TO THE CALCIFICATION AT THE ARCH OF THE RCA. THEREFORE, THE PHYSICIAN RETRIEVED THE CYPHER SELECT+ FROM THE PATIENT AND THE STENT WAS CONFIRMED TO BE MISALIGNED A LITTLE ON THE SDS TOWARDS THE DISTAL PORTION. USE OF FORCE DURING USE WAS NOT REPORTED. TO FINISH THE PROCEDURE, ADDITIONAL PRE-DILATION WAS CONDUCTED AND A NEW CYPHER SELECT+ WAS IMPLANTED AT THE TARGET LESION. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE OR DURING THE PROCEDURE. THE LESION WAS A DE-NOVO, MODERATELY CALCIFIED AND HIGHLY TORTUOUS LESION. THERE WAS 90% STENOSIS. THE PRODUCT WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE WITHOUT ANY DIFFICULTY. NO ANOMALIES WERE NOTED PRIOR TO INSERTING PRODUCT INTO THE PATIENT. THE PRODUCT WAS RETURNED FOR EVALUATION AND WAS FOUND TO HAVE SQUEEZED STENT OMEGAS AND DAMAGED DISTAL TIP. THE REPORTER INDICATED THAT NEITHER THE STENT NOR THE DISTAL TIP DAMAGE WAS NOTED PRIOR TO SHIPMENT OF DEVICE FOR EVALUATION. ONE NON-STERILE CYPHER SELECT + (B)(4) 2.75 X 23 MM WAS RECEIVED COILED INSIDE 2 PLASTIC BAGS. TWO BENTS WERE OBSERVED 9 AND 17 CM FROM DISTAL END; THIS CONDITION ON THE SHAFT COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR THE ANALYSIS. INFLATION MEDIA RESIDUE WAS DETECTED. THE STENT WAS OBSERVED BETWEEN THE MARKER BANDS AND THE OMEGAS WERE SQUEEZED. THE DISTAL TIP WAS FLATTENED. THE CROSSING PROFILE OF THE STENT WAS NOT PERFORMED SINCE THE STENT PRESENTED DAMAGE. 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 "OFFSET/OUT OF POSITION" FAILURE WAS CONFIRMED SINCE THE OMEGAS WERE FOUND SQUEEZED CAUSING THE STENT TO BE OUT OF POSITION. THE EXACT CAUSE OF THE FAILURES REPORTED BY THE CUSTOMER AND THE DAMAGE FOUND IN THE DISTAL TIP COULD NOT BE DETERMINED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE ISSUE IS RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN. DIFFICULTY TRACKING A VESSEL 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. FACTORS THAT MAY CONTRIBUTE TO DIFFICULTY TRACKING A PRODUCT INCLUDE TORTUOUS VESSELS, CALCIFIED LESIONS OR AN INCREASED DIFFICULTY TO TRACK THE PRODUCT THROUGH AN EXISTING STENT. THE TRACKING DIFFICULTY AND STENT OFFSET/OUT POSITION REPORTED MAY BE ATTRIBUTED TO THE OPERATOR'S ATTEMPT TO CROSS A MODERATELY CALCIFIED AND TORTUOUS LESION. BASED ON THE INFORMATION AVAILABLE THERE ARE POSSIBLE VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. HOWEVER, THE DAMAGED TIP MAY BE ATTRIBUTED TO PRODUCT SHIPPING FACTORS.

    Description of Event or Problem · 1

    A FEMORAL APPROACH WAS CHOSEN FOR THE PROCEDURE. A GC (LAUNCHER) WAS ENGAGED AND A GW CROSSED THE LESION. IVUS AND PRE-DILATION WITH A BC (LACROSSE) WERE CONDUCTED. THEN, CYPHER SELECT+ (2.75/23MM) WAS DELIVERED TO THE DISTAL RIGHT CORONARY ARTERY (RCA), BUT IT COULD NOT BE DELIVERED DUE TO THE CALCIFICATION AT THE ARCH OF RCA. THEREFORE, THE PHYSICIAN RETRIEVED THE CYPHER SELECT+ FROM THE PATIENT AND THE STENT WAS CONFIRMED TO BE MISALIGNED A LITTLE ON THE SDS TOWARDS THE DISTAL PORTION, I.E. THE DISTAL EDGE OF THE STENT WAS MOVING TO THE DISTAL TIP OF THE SDS. TO FINISH THE PROCEDURE, ADDITIONAL PRE-DILATION WAS CONDUCTED AND A NEW CYPHER SELECT+ (SAME SIZE) WAS IMPLANTED AT THE TARGET LESION. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE OR DURING THE PROCEDURE. THE LESION WAS A DE-NOVO, MODERATELY CALCIFIED AND HIGHLY TORTUOUS LESION. THERE WAS 90% STENOSIS. THE PRODUCT WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE WITHOUT ANY DIFFICULTY. THE STENT WAS PROPERLY MOUNTED ON THE SDS PRIOR TO INSERTING IT INTO 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 15119121

    Patients

    Seq Age Sex Outcome Treatment
    1