BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1853092 · Received October 5, 2010

    Report

    Report Number
    3003742446-2010-00343
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 7, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE NON STERILE CYPHER US RX 2.50 X 28 WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE STENT WAS RECEIVED DETACHED FROM SDS INSIDE OF A SMALL PLASTIC BAG; THE STENT WAS DAMAGED AND THE ENDS HAD THE STRUTS UPLIFTED. DRIED BLOOD RESIDUES WERE OBSERVED ON THE GUIDE WIRE LUMEN. THE HUB AND SDS PRESENTED NO DAMAGE. NO OTHER ANOMALIES WERE OBSERVED ON THE RECEIVED UNIT. THE BALLOON WAS INSPECTED UNDER A MICROSCOPE BUMPING AND CRIMPING MARKS WERE NOTED. THE BALLOON WAS INFLATED WITH WATER AND NO ANOMALIES WERE NOTED. 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 REPORTED FAILURE BY THE CUSTOMER AS SDS TRACKING DIFFICULTY-THROUGH ANOTHER STENT COULD NOT BE EVALUATED BUT IS COMMONLY ASSOCIATED WITH PATIENT ANATOMY, VESSEL/LESION CHARACTERISTICS AND OPERATOR TECHNIQUE. THE REPORTED CUSTOMER COMPLAINT OF STENT DISLODGMENT AND STRUT UP-LIFT WAS CONFIRMED THROUGH FAILURE ANALYSIS. A REVIEW OF THE ANALYSIS AND THE INFORMATION PROVIDED SUGGESTS THAT PROCEDURAL AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION IN THE ANALYSIS, THE DHR OR THE INFORMATION PROVIDED THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CYPHER STENT (CXS28250) WAS INSERTED INTO THE PROXIMAL CIRCUMFLEX. THE SDS WOULD NOT CROSS THE IN STENT RESTENOSIS OF A PREVIOUSLY IMPLANTED 2.5 X 18MM MULTI-LINK STENT (IMPLANTED (B)(6)1999). THE PHYSICIAN ATTEMPTED TO RETRACT THE STENT INTO THE GUIDE CATHETER. BECAUSE THE CIRCUMFLEX HAD AN INFERIOR TAKEOFF AND THE GUIDE TIP WAS NOT COAXIAL, THE PROXIMAL END OF THE STENT WAS FLARED AND WOULD NOT ENTER THE 6FRENCH BSX GUIDE. AFTER MULTIPLE ATTEMPTS TO WITHDRAW THE SDS INTO THE GUIDE, THE STENT SLIPPED OFF THE BALLOON AND ONTO THE WIRE THAT WAS INSERTED INTO THE CIRCUMFLEX. THE PHYSICIAN MOVED THE STENT AND REMOVED THE DELIVERY SYSTEM AND GUIDE CATHETER AS A UNIT TO THE RIGHT ILIAC. THE STENT DISLODGED AFTER THE PHYSICIAN GOT IT INTO THE COMMON ILIAC. ANOTHER SHEATH WAS INSERTED INTO THE PATIENT (7F). THE STENT WAS SECURED WITH A SNARE THROUGH THE RIGHT FEMORAL SHEATH. THE STENT AND WIRE WERE PULLED OUT WITH ANOTHER SNARE FROM THE LEFT FEMORAL SHEATH. THE PATIENT TOLERATED THE PROCEDURE FINE AND IS DOING OK. THERE WERE NO OTHER PRODUCT ANOMALIES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15201943

    Patients

    Seq Age Sex Outcome Treatment
    1