BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2171408 · Received August 29, 2008

    Report

    Report Number
    9616099-2008-02128
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 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 PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONALLY, THE STERILE LOT NUMBER IS NOT KNOWN. NO FURTHER ANALYSIS CAN BE PERFORMED FOR COMPLAINTS REPORTED WITHOUT A LOT NUMBER AND FOR WHICH THE ASSOCIATED PRODUCTS WILL NOT BE RETURNED. STENT FRACTURE IS A KNOWN COMPLICATION OF CORONARY STENTING AND IS ADDRESSED AS SUCH IN THE PRODUCT IFU. STENT FRACTURE CAN LEAD TO SUBSEQUENT RESTENOSIS AT THE FRACTURE SITE, WHICH MAY REQUIRE ADDITIONAL TREATMENT. THERE ARE NO FILMS AVAILABLE FOR REVIEW. WITHOUT THE RETURN OF THE PRODUCT OR IMAGES FOR REVIEW, IT IS NOT POSSIBLE TO CONFIRM THE STENT FRACTURE.

    Description of Event or Problem · 1

    A MALE PATIENT WAS ADMITTED FOR CORONARY STENTING OF THE MID THROUGH DISTAL RCA. THE LESION WAS A RESTENOSIS OF 2 CYPHERS (SIZES UNKNOWN), WHICH WERE IMPLANTED IN 2007. DETAILS REGARDING THIS PROCEDURE ARE NOT KNOWN. ADDITIONALLY, IT WAS NOTED THAT THERE WAS A FRACTURE WITHIN THE OVERLAPPING PORTION OF THE STENTS. THE VESSEL WAS MODERATELY CALCIFIED AND HIGHLY TORTUOUS. THERE WAS 75% STENOSIS. FEMORAL APPROACH WAS CHOSEN FOR THE PROCEDURE. PRE-DILATION WAS NOT CONDUCTED. A 3.0 X 13MM CYPHER STENT WAS DELIVERED TO THE TARGET LESION WITH NO ISSUES. THEN, THE BALLOON WAS INFLATED; HOWEVER, IT RUPTURED AT 2ATMS OF PRESSURE. THE RUPTURE WAS CONFIRMED WITH BLOOD FLOWING BACK INTO THE INFLATION LUMEN OF THE DEVICE. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE DEVICE BACK INTO THE GUIDING CATHETER (HEARTRAIL: 7FR AL1), BUT IT BECAME STUCK ON THE DISTAL TIP OF THE CATHETER AND THE STENT DISLODGED IN THE PROXIMAL RCA. IN ADDITION, WHEN THE PHYSICIAN RETRIEVED THE DEVICE, THE GUIDE WIRE (BMW) CAME OUT OF THE TARGET LESION. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE STENT WITH A SNARE DEVICE, HOWEVER, A DISSECTION OCCURRED (DUE TO THE SNARE PUSHING BACK AND FORTH INSIDE THE VESSEL). THE STENT WAS NOT SPARED. THE PHYSICIAN DECIDED TO DEPLOY THE STENT WHERE IT WAS. A NEW GUIDE WIRE (PT2) WAS ADVANCED THROUGH SIDE STRUTS OF THE DISLODGED STENT, AND THE STENT WAS EXPANDED WITH TWO BALLOONS (MAVERICK: 1.5/12MM THEN QUANTUM MAVERICK: 3.0/12MM). THEN, TO TREAT THE DISSECTION, A TAXUS (3.0/28MM) WAS IMPLANTED FROM THE PROXIMAL RCA, THROUGH THE DISLODGED CYPHER STENT, AND TO THE PROXIMAL END OF THE INITIALLY IMPLANTED CYPHER IN THE MID-RCA. THE PROCEDURE WAS FINISHED. 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 13410497

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R NEL'S LIGHT| GC: HEARTRAIL (7FR AL1)| PT2| BC: MAVERICK 1.5/12MM| QUANTUM MAVERICK 3.0/12MM| GW: BMW