BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1760019 · Received July 16, 2010

    Report

    Report Number
    9616099-2010-00546
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 22, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: GW: FIELDER, ROTAFLOPPY; GC: LAUNCHER JL4.0 7F; BC: APEX OTW 1.5/8MM, IKAZUCHI REVO 2.5/15MM; SHEATH: ABBOTT; OTHER: KIWAMI, ROTA 1.5MM, ROTA 1.75MM. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE SDS OF A CYPHER STENT KINKED AND THE STENT STRUTS WERE UPLIFTED AFTER FAILED ATTEMPTS TO DELIVER THE PRODUCT TO THE TARGET LESION. THE PATIENT HAD A PERCUTANEOUS CORONARY INTERVENTION PERFORMED TO TREAT THE PROXIMAL/MID LEFT ANTERIOR DESCENDING (LAD) TARGET LESION. THE LESION WAS PRE-DILATED AND ROTABLATOR USED BEFORE A CYPHER SELECT PLUS 2.5 X 18 MM WAS INSERTED TOWARDS THE TARGET LESION (TL) BUT IT BECAME STUCK PROXIMAL TO THE TL. THE PHYSICIAN THEN REMOVED THE CYPHER SDS AND ADDITIONAL PRE-DILATION WAS CONDUCTED. THE PHYSICIAN THEN ATTEMPTED TO ACCESS THE LESION AGAIN WITH THE CYPHER SDS BUT WAS NOT SUCCESSFUL. THE CYPHER SDS WAS THEN REMOVED AND UPON INSPECTION, THE DISTAL STENT STRUTS WERE NOTED TO BE UPLIFTED/FLARED AND THE SDS WAS KINKED/BENT AT 20-30 CM FROM THE LUER HUB. A 4 FR. KIWAMI CATHETER WAS THEN USED TO SUCCESSFULLY DELIVER A NEW CYPHER SELECT PLUS 2.5 X 18 MM STENT DISTALLY AND ALSO A CYPHER SELECT PLUS 2.5 X 28 MM STENT PROXIMAL TO THE FIRST STENT IN THE PROXIMAL LAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN INSPECTED THE DEVICE PRIOR TO USE AND NO PROBLEMS WERE NOTED. THE PROXIMAL/MID LAD TARGET LESION WAS REPORTED TO BE: DE NOVO, MODERATELY CALCIFIED, SLIGHTLY TORTUOUS, AND A 99% STENOSIS. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE AND NO PROBLEMS WERE NOTED. NO RESISTANCE/FRICTION WAS REPORTED DURING WITHDRAWAL OF THE SDS. IT WAS NOT INDICATED IF EXCESSIVE FORCE WAS USED IN ATTEMPTING TO ACCESS/CROSS THE TARGET LESION. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE FAILURE REPORTED COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN FOR EVALUATION. DIFFICULTY TRACKING A PRODUCT THROUGH AN ANATOMICAL STRUCTURE IS A KNOWN PROCEDURAL OCCURRENCE. THESE TYPES OF DIFFICULTIES OCCURRING DURING THE CLINICAL USE OF THE DEVICE ARE USUALLY ADDRESSED BY MODIFICATION IN TECHNIQUE OR SUBSTITUTION WITH ANOTHER DEVICE. CROSSING DIFFICULTY IS MOST COMMONLY RELATED TO THE PATIENT'S ANATOMY, VESSEL CHARACTERISTICS, OPERATOR'S TECHNIQUE AND APPROPRIATE DEVICE SELECTION. THE RELATIONSHIP BETWEEN THE FAILURE TO CROSS OR TRACK A PRODUCT AND THE PRODUCT ITSELF IS NOT CLEAR, BUT FACTORS SUCH AS TORTUOUS VESSELS, CALCIFIED LESIONS OR AN INCREASED DIFFICULTY TO TRACK THE PRODUCT THROUGH AN EXISTING STENT MAY CONTRIBUTE TO IT. THE UPLIFTED STRUTS AND KINK MAY BE ATTRIBUTED TO THE OPERATOR'S ATTEMPTS TO CROSS A CALCIFIED AND TORTUOUS LESION. BASED ON THE INFORMATION AVAILABLE THERE ARE POSSIBLE VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PATIENT HAD A PERCUTANEOUS CORONARY INTERVENTION PERFORMED TO TREAT THE PROXIMAL/MID LEFT ANTERIOR DESCENDING (LAD) TARGET LESION. THE LESION WAS PRE-DILATED WITH AN APEX 1.5 X 8 MM BALLOON CATHETER. THE PHYSICIAN THEN USED ROTABLATOR TO THE VESSEL/LESION USING 1.5 AND THEN 1.75 MM CATHETERS. THE PHYSICIAN THEN ADVANCED A CYPHER SELECT PLUS 2.5 X 18 MM STENT DELIVERY SYSTEM (SDS) TOWARDS THE TARGET LESION (TL) BUT IT BECAME STUCK PROXIMAL TO THE TL. THE PHYSICIAN THEN REMOVED THE CYPHER SDS. THE PHYSICIAN THEN PRE-DILATED THE LESION USING AN IKAZUCHI REVO 2.5 X 15 MM BALLOON CATHETER. THE PHYSICIAN THEN ATTEMPTED TO ACCESS THE LESION AGAIN WITH THE CYPHER SDS BUT WAS NOT SUCCESSFUL. THE CYPHER SDS WAS THEN REMOVED AND UPON INSPECTION, THE DISTAL STENT STRUTS WERE NOTED TO BE UPLIFTED/FLARED AND THE SDS WAS KINKED/BENT AT 20-30 CM FROM THE LUER HUB. A 4 FR. KIWAMI CATHETER WAS THEN USED TO SUCCESSFULLY DELIVER A NEW CYPHER SELECT PLUS 2.5 X 18 MM STENT DISTALLY AND ALSO A CYPHER SELECT PLUS 2.5 X 28 MM STENT PROXIMAL TO THE FIRST STENT IN THE PROXIMAL LAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN INSPECTED THE DEVICE PRIOR TO USE AND NO PROBLEMS WERE NOTED. THE PROXIMAL/MID LAD TARGET LESION WAS REPORTED TO BE: DE NOVO, MODERATELY CALCIFIED, SLIGHTLY TORTUOUS, AND A 99% STENOSIS. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE AND NO PROBLEMS WERE NOTED. NO RESISTANCE/FRICTION WAS REPORTED DURING WITHDRAWAL OF THE SDS. IT WAS NOT INDICATED IF EXCESSIVE FORCE WAS USED IN ATTEMPTING TO ACCESS/CROSS THE TL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 15091166

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR