BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1862094 · Received October 8, 2010

    Report

    Report Number
    9616099-2010-00774
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A PCI, A CYPHER STENT DISLODGED WHILE TRYING TO WITHDRAW IT FROM THE LESION. THE TARGET LESION WAS THE OBTUSE MARGINAL BUT THE STENT COULD NOT BE DELIVERED THROUGH A VERY CALCIFIED LEFT MAIN AND PROXIMAL CIRCUMFLEX. A FLOW LIMITING DISSECTION WAS NOTED AT THIS TIME, SO THE PRODUCT WAS QUICKLY REMOVED TO CONDUCT BALLOON DILATION TO TREAT THE DISSECTION. UPON WITHDRAWAL OF THE PRODUCT THROUGH THE GUIDE CATHETER, THE STENT DISLODGED IN THE Y-CONNECTOR. THE PHYSICIAN USED THE CYPHER STENT DELIVERY SYSTEM TO TREAT THE DISSECTION ACHIEVING RESTORATION OF BLOOD FLOW. NO OTHER INTERVENTION WAS CONDUCTED. THE STENT WAS LOST OUTSIDE OF THE PATIENT AND COULD NOT BE RETURNED WITH THE SDS FOR EVALUATION. THERE WERE NO ISSUES NOTED WHILE PREPARING THE PRODUCT FOR USE FOLLOWING THE IFU INSTRUCTIONS. ONE NON-STERILE CYPHER SELECT+ 2.75 MM X 23 MM WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. THE BALLOON WAS DEFLATED. THE STENT WAS NOT RECEIVED. NO KINKS OR BENTS WERE OBSERVED. NO OTHER ANOMALIES WERE NOTICED. A CROSSING PROFILE COULD NOT BE PERFORMED SINCE THE STENT WAS NOT RECEIVED. DURING THE MICROSCOPIC ANALYSIS CRIMPING MARKS WERE OBSERVED IN THE BALLOON. REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. DISSECTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS DURING PCI. IN THE PRECAUTIONS SECTION OF THE IFU, IT INDICATES THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION. THIS IS AN INHERENT RISK OF THE PROCEDURE. DIFFICULTY TRACKING A PRODUCT THROUGH AN ANATOMICAL STRUCTURE IS A KNOWN PROCEDURAL OCCURRENCE. TRACKING AND CROSSING DIFFICULTY ARE MOST COMMONLY RELATED TO THE PATIENT'S ANATOMY, VESSEL CHARACTERISTICS, OPERATOR'S TECHNIQUE AND APPROPRIATE DEVICE SELECTION. FACTORS THAT MAY INCREASE THE DIFFICULTY TO DELIVER A PRODUCT INCLUDE TORTUOUS VESSELS, CALCIFIED LESIONS OR AN INCREASED DIFFICULTY TO TRACK THE PRODUCT THROUGH AN EXISTING STENT. THE IFU INSTRUCTS THAT SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE SDS PRE-STENT IMPLANTATION, THE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. WHEN REMOVING THE SDS AS A SINGLE UNIT, DO NOT RETRACT THE DELIVERY SYSTEM INTO THE GUIDING CATHETER OR SHEATH. FAILURE TO FOLLOW STENT/SDS REMOVAL INSTRUCTIONS AND/OR APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR SDS COMPONENTS. THE STENT DISLODGEMENT WAS CONFIRMED. THE CAUSE OF THE FAILURES COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE DHR NOR THE ANALYSIS SUGGESTS THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED. BASED ON THE INFORMATION PROVIDED, THERE ARE POSSIBLE VESSEL CHARACTERISTICS (CALCIFIED VESSEL) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT, IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THE PRODUCT IS AVAILABLE, BUT HAS NOT BEEN RECEIVED AS OF THE INITIAL REPORT. 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    ADDENDUM RECEIVED 11/12/2010: WHEN THE DOCTOR TRIED TO PASS THE LESION WITH THE STENT, THERE WAS A DISSECTION AND HE DECIDED TO DEFLATE IT BY BALLOON. WHEN REMOVING THE STENT, IT DETACHED IN THE Y-CONNECTOR. THE PHYSICIAN DILATED THE DISSECTION WITH THE STENT DELIVERY SYSTEM TO GLUE AND RECOVER FLOW. PATIENT STATUS IS NORMAL.

    Description of Event or Problem · 1

    STENT CAME OFF DURING PROCEDURE. THE TARGET LESION WAS THE OBTUSE MARGINAL, BUT THE STENT COULD NOT CROSS FROM THE LEFT MAIN TO THE PROXIMAL CIRCUMFLEX. THE VESSEL WAS VERY CALCIFIED. THE LESION WAS PRE-DILATED, BUT THE STENT DID NOT GET TO THE LESION. HE DECIDED TO REMOVE STENT THROUGH THE GUIDE CATHETER AND PREDILATE LESION. WHEN REMOVING STENT , THE STENT DISLODGED IN THE Y-CONNECTOR.

    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 15145660

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR