BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1946220 · Received January 4, 2011

    Report

    Report Number
    9616099-2011-00005
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 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

    THIS (B)(4) CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADDITIONAL INFORMATION NOTED THAT THE STENT WAS POST-DILATED AFTER THE BALLOON BURST TO ENSURE FULL EXPANSION. THEREFORE, THIS EVENT WAS CHANGED FROM BEING REPORTED AS A MALFUNCTION TO A SERIOUS INJURY. DURING A PCI, THE BALLOON OF A CYPHER STENT DELIVERY SYSTEM BURST DURING INFLATION. ANOTHER BALLOON WAS USED TO FULLY EXPAND THE STENT AND THE EVENT RESOLVED WITHOUT SEQUEL. THE PATIENT WAS ADMITTED WITH A 90%, DE NOVO, SLIGHTLY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE VESSEL WAS SLIGHTLY TORTUOUS. A GUIDING CATHETER WAS ENGAGED AND A GUIDEWIRE CROSSED THE LESION. THEN, A 2.5 X 23MM CYPHER SELECT PLUS STENT WAS DELIVERED TO THE LESION, WITHOUT FRICTION, FOR DIRECT STENTING. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. THE STENT WAS INFLATED TO 12ATM, AND THE BALLOON RUPTURED. THE RUPTURE WAS CONFIRMED, BY CONTRAST MEDIUM LEAKAGE, UNDER CORONARY ANGIOGRAPHY. THEREFORE, THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND POST-DILATION WAS CONDUCTED WITH A 2.5 X 15MM VOYAGER BALLOON CATHETER, TO FURTHER EXPAND THE STENT AND ACHIEVE OPTIMAL EXPANSION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. ONE NON-STERILE 2.50X23 MM CYPHER SELECT + (B)(4) WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. THREE KINKS WERE OBSERVED AT 9.5, 15.5 AND 46 CM FROM THE DISTAL END. THIS CONDITION ON THE SHAFT COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR ANALYSIS. THE BALLOON WAS ALREADY INFLATED AND THE STENT WAS NOT RECEIVED. DURING FUNCTIONAL TEST NO LEAKAGE WAS DETECTED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED BALLOON BURST WAS NOT CONFIRMED SINCE NO LEAKAGE WAS OBSERVED. THE EXACT CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. HOWEVER, THERE ARE VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE INABILITY TO INFLATE THE PRODUCT BEYOND 12 ATM. NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE REPORTER ISSUE IS RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE PREFACE SHEATH HAD A CLOTTING PROBLEM WHERE THE STOPCOCK TUBING MEETS THE HUB. VISUAL ANALYSIS REVEALED NO ANOMALIES IN THE PRODUCT RECEIVED; SIDE PORT HAD NO EVIDENCE OF CLOTTING ISSUES. DIMENSIONAL AND FUNCTIONAL ANALYSES WERE PERFORMED AND PREFACE SHEATH MEETS ALL SPECIFICATIONS. DHR REVIEW COULD NOT BE PERFORMED DUE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. COMPLAINT CONDITION CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS (B)(4) CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THE FOLLOWING PRODUCTS WERE USED DURING THE INDEX PROCEDURE: A MACH1 FL4 GUIDING CATHETER AND A RINATO GUIDEWIRE. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED WITH A 90%, DE NOVO, SLIGHTLY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE VESSEL WAS SLIGHTLY TORTUOUS. A GUIDING CATHETER WAS ENGAGED AND A GUIDEWIRE CROSSED THE LESION. THEN, A 2.5 X 23MM CYPHER SELECT PLUS STENT WAS DELIVERED TO THE LESION, WITHOUT FRICTION, FOR DIRECT STENTING. THE STENT WAS INFLATED TO 12ATM, AND THE BALLOON RUPTURED. THE RUPTURE WAS CONFIRMED, BY CONTRAST MEDIUM LEAKAGE, UNDER CORONARY ANGIOGRAPHY. THEREFORE, THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND POST-DILATION WAS CONDUCTED WITH A 2.5 X 15MM VOYAGER BALLOON CATHETER, TO FURTHER INFLATE THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE.

    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 15207777

    Patients

    Seq Age Sex Outcome Treatment
    1