BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2181737 · Received July 27, 2011

    Report

    Report Number
    9616099-2011-00547
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    March 14, 2011
    Report Date
    June 30, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMITTED WITH A 90% STENOSIS IN THE POSTERIOR DESCENDING ARTERY (PDA). THE LESION WAS DE-NOVO, HEAVILY CALCIFIED AND MODERATELY TORTUOUS. THERE WAS HEAVY CALCIFICATION AT DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED WITH A BALLOON AND A 2.5 X 23MM CYPHER SELECT PLUS WAS DELIVERED TO THE TARGET LESION, BUT IT WOULD NOT CROSS THE FLEXION AT THE DISTAL RCA. THE PHYSICIAN PUSHED THE CYPHER SELECT PLUS SEVERAL TIMES AND TRIED TO DELIVER IT, BUT THE CYPHER SELECT PLUS COULD NOT BE DELIVERED. THEREFORE, THE CYPHER SELECT PLUS WAS RETRIEVED AND CHECKED OUTSIDE THE PATIENT AND THEN THE DISTAL EDGE OF THE STENT WAS CONFIRMED TO BE FLARED. CONSEQUENTLY, A DIFFERENT DRUG-ELUTING STENT (XIENCE: 2.5MM) WAS IMPLANTED AT THE TARGET LESION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS DUE TO THE PATIENT'S INFECTIOUS DISEASE. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. 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 UPLIFTED STRUTS MAY BE ATTRIBUTED TO THE OPERATOR'S ATTEMPT TO DELIVER THE STENT TO THE TARGET LESION. BASED ON THE INFORMATION AVAILABLE THERE ARE POSSIBLE VESSEL CHARACTERISTICS (HEAVY CALCIFICATION AND TORTUOUSITY) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMITTED WITH A 90% STENOSIS IN THE POSTERIOR DESCENDING ARTERY (PDA). THE LESION WAS DE-NOVO, HEAVILY CALCIFIED AND MODERATELY TORTUOUS. THERE WAS HEAVY CALCIFICATION AT DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED WITH A I-BP22 BALLOON AND A 2.5 X 23MM CYPHER SELECT PLUS WAS DELIVERED TO THE TARGET LESION, BUT IT WOULD NOT CROSS THE FLEXION AT THE DISTAL RCA. THE PHYSICIAN PUSHED THE CYPHER SELECT PLUS SEVERAL TIMES AND TRIED TO DELIVER IT, BUT THE CYPHER SELECT PLUS COULD NOT BE DELIVERED. THEREFORE, THE CYPHER SELECT PLUS WAS RETRIEVED AND CHECKED OUTSIDE THE PATIENT AND THEN THE DISTAL EDGE OF THE STENT WAS CONFIRMED TO BE FLARED. CONSEQUENTLY, A DIFFERENT DRUG-ELUTING STENT (XIENCE: 2.5MM) WAS IMPLANTED AT THE TARGET LESION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS DUE TO THE PATIENT'S INFECTIOUS DISEASE. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. I-BP22 BALLOON AND 2.5MM XIENCE STENT.

    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 15233828

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR RUNTHROUGH GUIDEWIRE