BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1061392 · Received June 16, 2008

    Report

    Report Number
    3003742446-2008-00107
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 21, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE STENT DISLODGED FROM THE DELIVERY SYSTEM REQUIRING SNARING. THE REPORT RECEIVED INDICATED THAT DURING A PROCEDURE TO THE RIGHT CORONARY ARTERY (RCA), THE LESION WAS PRE-DILATED SEVERAL TIMES, THEN THE 3.00 X 18MM CYPHER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. THEREFORE, THE PHYSICIAN PERFORMED AND ANGIOGRAM AND FOUND THE STENT WAS ACCORDIONED AND DECIDED TO REMOVE THE SDS. WHILE ATTEMPTING TO REMOVE THE SDS THROUGH THE SHEATH, THE STENT DISLODGED AND TRAVELED TO THE SUPERFICIAL FEMORAL ARTERY (SFA). CONSEQUENTLY, THE PHYSICIAN SNARED THE STENT AND CONTINUED THE TREATMENT OF THE RCA. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. ADDITIONAL INFORMATION INDICATED THE VESSEL WAS TORTUOUS, THE TARGET LESION INCLUDED TREATMENT OF MULTIPLE LESIONS STARTING IN THE PROXIMAL RCA AND MOVING TO THE MID RCA. FURTHER INFORMATION INDICATED THE DEVICE WAS PREPPED AS PER THE INSTRUCTIONS FOR USE AND THERE WERE NO DIFFICULTIES; THE DEVICE HAD BEEN INSPECTED PRIOR TO USE AND THERE WERE NO 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 6 FRENCH SHEATH| BSC MAVERICK BALLOON| 190CM ABBOTT S'PORT WIRE| MEDTRONIC LAUNCHER JR4