BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1190286 · Received October 6, 2008

    Report

    Report Number
    9616099-2008-02392
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOREIGN CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS MALE PT WAS ADMITTED FOR CORONARY EVALUATION. ANGIOGRAPHY REVEALED A 90% DE NOVO, SLIGHTLY CALCIFIED LESION IN THE PROXIMAL RCA. THE VESSEL WAS DESCRIBED AS A MODERATELY TORTUOUS. IT IS UNK IF PRE-DILATION WAS CONDUCTED. A 3.0X33MM CYPHER STENT WAS IMPLANTED IN THE PROXIMAL RCA WITHOUT DIFFICULTY. THEN, A 3.5X13MM CYPHER STENT WAS POSITIONED AT THE OSTIUM OF THE RCA, OVERLAPPING THE FIRST CYPHER. OF NOTE, THE GUIDING CATHETER WAS "LOOSELY SEATED WITHIN THE OSTIUM TO ALLOW FOR THE STENT PLACEMENT. THE DEVICE WAS DEPLOYED; HOWEVER, WHEN INFLATION PRESSURE REACHED 2 APPROX 3 ATM, THE GUIDING CATHETER (SHERPA: SHAPE UNK) DISENGAGED, AND THE STENT BECAME DISLODGED FROM THE BALLOON. A SNARE WAS INSERTED TO RETRIEVE THE DISLODGED STENT. THE DISLODGED STENT WAS PULLED BACK TO THE FEMORAL ACCESS SITE BY TANGLING THE GUIDE WIRE AND THE SNARE AROUND THE STENT. HOWEVER, WHEN THE STENT REACHED THE TIP OF THE SHEATH IT COULD NOT BE DRAWN INTO THE SHEATH DUE TO TH PARTIAL EXPANSION OF THE STENT. A SURGICAL CUT-DOWN PROCEDURE WAS PERFORMED TO REMOVE THE STENT FROM THE FEMORAL ARTERY. NO FURTHER TREATMENT WAS CONDUCTED AT THE OSTIUM OF THE RCA. THE PROCEDURE WAS FINISHED AND THE PT WAS DISCHARGED IN STABLE CONDITION.

    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 13431884

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R GC: SHERPA| SNARE DEVICE| GW: NEOS