BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2200764 · Received August 11, 2011

    Report

    Report Number
    9616099-2011-00593
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 26, 2011
    Report Date
    September 15, 2011
    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

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A PROCEDURE, THE 3.0 X 13MMM CYPHER SELECT PLUS STENT COULD NOT BE DELIVERED TO THE TARGET LESION AFTER PROPER PRE-DILATATION WITH A 2MM BALLOON. THE TARGET LESION WAS LOCATED IN THE OSTIAL LAD. THE LESION WAS CALCIFIED. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE DEVICE THROUGH THE GUIDE CATHETER. WHILE PULLING THE STENT BACK IT BECAME STUCK AT THE MOUTH OF THE GUIDING CATHETER AND DISLODGED FROM THE BALLOON. THE PHYSICIAN MANAGED TO REMOVE THE STENT FROM THE CORONARY ARTERY, BUT IT SLIPPED AND WENT INTO THE RIGHT COMMON ILIAC ARTERY. THE TARGET LESION WAS EVENTUALLY TREATED WITH ANOTHER STENT. THE PATIENT IS IN GOOD CONDITION. ONE NON-STERILE CYPHER SELECT + 3.00X13MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE STENT WAS NOT RECEIVED. THE BALLOON WAS NOT INFLATED. MARKS OF BUMPING AND CRIMPING WERE OBSERVED IN THE BALLOON. NO MORE ANOMALIES WERE FOUND. CROSSING PROFILE COULD NOT BE PERFORMED SINCE THE STENT WAS NOT RECEIVED. DURING MICROSCOPIC ANALYSIS CRIMPING AND BUMPING MARKS WERE OBSERVED IN THE BALLOON. 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 "STENT DISLODGED" WAS CONFIRMED. THE CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. DIFFICULTY TRACKING A PRODUCT THROUGH AN ANATOMICAL STRUCTURE 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. TRACKING DIFFICULTY IS MOST COMMONLY RELATED TO THE PATIENT'S ANATOMY, VESSEL CHARACTERISTICS, OPERATOR'S TECHNIQUE AND APPROPRIATE DEVICE SELECTION. FACTORS SUCH AS TORTUOUS VESSELS, CALCIFIED LESIONS OR AN INCREASED DIFFICULTY TO TRACK THE PRODUCT THROUGH AN EXISTING STENT MAY CONTRIBUTE TO IT. THE IFU INSTRUCTS THAT HOLD 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. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE POSSIBLE VESSEL CHARACTERISTICS (CALCIFICATION) AND PROCEDURAL FACTORS (PULLING BACK INTO THE GUIDE CATHETER) THAT MAY HAVE CONTRIBUTED TO THE DIFFICULTY TO DELIVER THE PRODUCT TO THE LESION AND TO THE STENT DISLODGEMENT. NEITHER THE DHR REVIEW NOT THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED FAILURE IS RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE 3.0 X 13MMM CYPHER SELECT PLUS STENT COULD NOT BE DELIVERED INTO THE LESION AFTER PROPER PRE-DILATATION WITH A 2MM BALLOON. WHILE PULLING THE STENT BACK IT BECAME STUCK AT THE MOUTH OF THE GUIDING CATHETER AND DISLODGED FROM THE BALLOON. THE PHYSICIAN MANAGED TO REMOVE THE STENT FROM THE CORONARY ARTERY BUT IT SLIPPED AND WENT INTO THE RIGHT COMMON ILIAC ARTERY. THE TARGET LESION WAS LOCATED IN THE OSTIAL LAD. THE LESION WAS CALCIFIED. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE DEVICE THROUGH THE GUIDE CATHETER. THE TARGET LESION WAS EVENTUALLY TREATED WITH ANOTHER STENT. THE PATIENT IS IN GOOD CONDITION.

    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 15290485

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention