BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2132493 · Received June 17, 2011

    Report

    Report Number
    9616099-2011-00424
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 23, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION. HOWEVER, THE ENGINEERING ANALYSIS IS NOT YET COMPLETE. 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.

    Additional Manufacturer Narrative · 1

    A REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PHYSICIAN FELT DIFFICULT DELIVERING A CYPHER STENT TO THE LESION. WHEN THE PHYSICIAN WITHDREW THE PRODUCT FROM THE PATIENT, THE DISTAL STENT STRUTS WERE UPLIFTED. THE TARGET LESION WAS THE LAD. THE VESSEL WAS SLIGHTLY CALCIFIED, TORTUOUS, AND ANGLED. THE LESION WAS PRE-DILATED BEFORE THE CYPHER STENT WAS INSERTED. ONE NON-STERILE CYPHER SELECT + 2.50X13 MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE SDS WAS KINKED AT 5.5 CM AND 16 CM FROM THE DISTAL END; THIS CONDITION ON THE SHAFT COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR THE ANALYSIS. THE STENT WAS MOUNTED IN ITS ORIGINAL POSITION BETWEEN THE MARKER BANDS. THE DISTAL STRUTS OF THE STENT WERE UPLIFTED. THE CROSSING PROFILE WAS MEASURED FOR THE MIDDLE AND PROXIMAL SECTIONS OF THE STENT AND WAS FOUND WITHIN SPECIFICATION. THE DISTAL SECTION COULD NOT BE MEASURED DUE TO THE UPLIFTED CONDITION IN THIS AREA. 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 STRUT UPLIFT WAS CONFIRMED. THE EXACT CAUSE OF THE REPORTED FAILURES COULD NOT BE DETERMINED. HOWEVER, THERE ARE LESION CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE TRACKING DIFFICULTY RESULTING IN UPLIFTED STENT STRUTS. 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. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE PHYSICIAN FELT DIFFICULT TO DELIVER. SO HE PULLED BACK AND THE CYPHER TIP WAS OPENED LITTLE BIT. WHEN THE PRODUCT WAS RETURNED IT WAS NOTED THAT THE DISTAL STRUTS WERE UPLIFTED.

    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 15321303

    Patients

    Seq Age Sex Outcome Treatment
    1