BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1842762 · Received September 23, 2010

    Report

    Report Number
    9616099-2010-00715
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 28, 2010
    Report Date
    August 30, 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

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PHYSICIAN EXPERIENCED DIFFICULTY DELIVERING A CYPHER STENT TO THE TARGET LESION. THE TARGET LESION FOR THE PROCEDURE WAS THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS REPORTED TO BE: DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND A 90% STENOSIS. PRE-DILATION WAS CONDUCTED BEFORE A CYPHER SELECT PLUS 3.5 X 28 MM STENT WAS INSERTED. THE SDS BECAME STUCK AT AN AREA OF SEVERE CALCIFICATION PROXIMAL TO THE LESION AND THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE DEVICE FURTHER. THE PHYSICIAN REMOVED THE CYPHER SDS SUCCESSFULLY FROM THE PATIENT AND ADDITIONAL PRE-DILATATION WAS CONDUCTED. CYPHER DELIVERY WAS ONCE AGAIN ATTEMPTED WITHOUT SUCCESS AS THE PRODUCT WAS NOT ABLE TO REACH THE INTENDED TARGET LESION. THE CYPHER SELECT PLUS WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND ANOTHER PRODUCT WAS USED TO SUCCESSFULLY TREAT THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN DID NOT NOTE ANY ANOMALIES UPON INSPECTION OF THE DEVICE PRIOR TO USE. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND NO PROBLEMS WERE NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON-STERILE CYPHER SELECT + 3.50MM X 28MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE SDS WAS WAVY. 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 MARKER BANDS, THE DISTAL STRUTS WERE UPLIFTED. THE DISTAL STRUTS OF THE STENT WERE UPLIFTED AND THE DISTAL TIP WAS CRUSHED. A CROSSING PROFILE WAS MEASURED FOR THE MIDDLE AND PROXIMAL SECTIONS OF THE STENT AND WAS FOUND WITHIN SPECIFICATION. THE DISTAL SECTION COULD NOT BE MEASURE 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 EXACT CAUSE OF THE STENT STRUT UPLIFT AND DISTAL TIP CRUSHED COULD NOT BE DETERMINED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THESE ISSUES ARE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. DIFFICULTY CROSSING AND TRACKING A LESION OF 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. 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 TRACKING DIFFICULTY. THE UPLIFTED STRUTS DISTAL TIP DAMAGE MAY BE ATTRIBUTED TO THE OPERATOR'S MULTIPLE ATTEMPTS TO CROSS A HIGHLY CALCIFIED AND TORTUOUS LESION. BASED ON THE INFORMATION AVAILABLE THERE ARE POSSIBLE VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: INFLATION DEVICE: GOODMAN; GW: RINATO; GC: HEARTRAIL 7F JL4; BC: LACROSSE 2.5/15MM, HIRYU 3.0/15MM; SHEATH: TERUMO; STENT: XIENCE 3.5/28MM. THE TARGET LESION FOR PROCEDURE WAS THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS REPORTED TO BE: DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND A 90% STENOSIS. THE TL WAS PRE-DILATED INITIALLY USING TWO BALLOON CATHETERS: A LACROSSE 2.5 X 15 MM AND A HIRYU 3.0 X 15 MM. THE PHYSICIAN DID NOT NOTE ANY ANOMALIES UPON INSPECTION OF THE DEVICE PRIOR TO USE. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND NO PROBLEMS WERE NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) USING THE FEMORAL APPROACH AFTER PRE-DILATING THE TARGET LESION (TL) TWICE, THE PHYSICIAN EXPERIENCED TRACKING DIFFICULTY WHILE ADVANCING THE CYPHER SELECT PLUS 3.5 X 28 MM STENT DELIVERY SYSTEM (SDS) TO THE TL. THE SDS BECAME STUCK AT AN AREA OF SEVERE CALCIFICATION PROXIMAL TO THE TL AND THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE DEVICE FURTHER. THE PHYSICIAN REMOVED THE CYPHER SDS SUCCESSFULLY FROM THE PATIENT AND PRE-DILATED THE TL AGAIN USING A HIRYU 3.0 X 15 MM BALLOON CATHETER. THE PHYSICIAN THEN ATTEMPTED TO ACCESS THE TL AGAIN WITH THE CYPHER SELECT PLUS SDS BUT WAS NOT SUCCESSFUL/WAS NOT ABLE TO REACH THE INTENDED TL. THE CYPHER SELECT PLUS WAS SUCCESSFULLY REMOVED AGAIN FROM THE PATIENT. A XIENCE 3.5 X 28 MM STENT WAS USED TO SUCCESSFULLY TREAT THE PATIENT/TL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. INSPECTION OF THE RETURNED PRODUCT INDICATED THAT THE DISTAL STENT STRUTS OF THE CYPHER SELECT PLUS 3.5 X 28 MM STENT 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 15084386

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR