BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1030577 · Received April 14, 2008

    Report

    Report Number
    9616099-2008-00991
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TARGET LESION WAS THE DISTAL (LAD) LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS A DE NOVO, MODERATELY TORTUOUS AND SLIGHTLY TORTUOUS. THERE WAS 90% STENOSIS. RADIAL APPROACH WAS CHOSEN FOR THE PROCEDURE. A GUIDE WIRE (RUNTHROUGH NS) WAS INSERTED INTO LAD AND PRE-DILATION WITH A BALLOON (SPRINTER 2.0MM) WAS CONDUCTED AT THE TARGET LESION. ADDITIONAL INFORMATION INDICATED THAT THE LOT NUMBER IS 13308065. ALL THE PRODUCTS WERE PREP PER INSTRUCTION FOR USE (IFU), AND NO LEAKS WERE NOTED DURING PREP, BUT WERE NOTED UNTIL INFLATION OF THE BALLOON. PRIOR TO INSERTING IN THE PATIENT, THERE WERE NO HOLES, TEARS, RUPTURES, ETC IN THE BALLOON. AFTER THE PRODUCT WAS REMOVED FROM THE PATIENT, THERE WERE NO HOLES, TEARS, RUPTURES, ETC IN THE BALLOON. A LAUNCHER (6FRENCH JL4) WAS USED, BUT THERE WAS NO INFORMATION REFERRED TO SHEATH INTRODUCTION. NO PROBLEMS WERE ENCOUNTERED ADVANCING, TRACKING OR REMOVING THE DEVICE FROM THE PATIENT. THIS WAS THE INITIAL USE OF THE DEVICE. DUE TO THE INABILITY TO INFLATE THE BALLOON, THE ATMOSPHERES ARE UNANSWERABLE. CONSTANT FLUOROSCOPY WAS PROBABLY PERFORMED, ALTHOUGH IT WAS NOT INDICATED IN THE REPORT. THE BALLOON BURST WAS NOT OBSERVED UNDER FLUOROSCOPY, BUT IT WAS NOTED AFTER REMOVAL. THE PHYSICIAN CONFIRMED THE BALLOON RUPTURE OUTSIDE THE PATIENT DUE TO LEAKAGE OF CONTRAST FROM THE TIP. AN INDEFLATOR WAS UTILIZED TO INFLATE THE BALLOON. NO FURTHER INFORMATION WAS AVAILABLE. 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 BALLOON FUNCTIONAL (MULTIPLE & PROLONGED) AND BURST TEST RESULTS WERE ACCEPTED ACCORDING TO SPECIFICATION. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT RETURN OF THE PRODUCT. REVIEW OF THE AVAILABLE INFORMATION DOES NOT MAKE IT POSSIBLE TO DETERMINE WHAT FACTORS MIGHT HAVE CONTRIBUTED TO THE EVENT. THIS PRODUCT IS SIMILAR TO US CYPHER.

    Description of Event or Problem · 1

    DURING A (PCI) PERCUTANEOUS CORONARY INTERVENTION, THE CYPHER (2.5/18MM) WAS DELIVERED TO THE TARGET LESION. IN ORDER TO IMPLANT THE CYPHER, PRESSURE WAS APPLIED, BUT THE PRESSURE WOULD NOT INCREASE AND THE BALLOON WOULD NOT INFLATE. SLIGHT LEAKAGE OF CONTRAST MEDIUM WAS OBSERVED. THEREFORE, THE PHYSICIAN RETRIEVED THE CYPHER FROM THE PATIENT AND CONFIRMED THE BALLOON TO BE RUPTURED AT THE TIP. THE PROCEDURE WAS FINISHED SUCCESSFULLY THE IMPLANT OF A DIFFERENT CYPHER (SAME SIZE). THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WAS CLINICALLY USED AND THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS DUE TO THE PATIENT'S INFECTIOUS DISEASE (HCV).

    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 13308065

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR GW: RUNTHROUGH NS| BC: SPRINGER 2.0/15MM| GC: LAUNCHER 6F JL4| GC: LAUNCHER 6F JL4| STENT: CYPHER 2.5/18MM