BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1061395 · Received June 16, 2008

    Report

    Report Number
    9616099-2008-01527
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION; HOWEVER, AS OF TO DATE, IT HAS NOT BEEN RETURNED. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT DURING A PROCEDURE TO THE CORONARY INTERVENTION TO THE MID LEFT ANTERIOR DESCENDING (LAD), THE LESION WAS PRE-DILATED, THEN THE 3.00X33MM CYPHER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, WHEN THE PHYSICIAN TRIED TO DEPLOY THE STENT, THE BALLOON DID NOT INFLATE COMPLETELY AND ONLY THE DISTAL AND PROXIMAL PARTS INFLATED A LITTLE. THEREFORE, THE PHYSICIAN DECIDED TO PULL BACK THE STENT; HOWEVER, THE STENT DISLODGED FROM THE BALLOON. THE STENT HAD MIGRATED AND WAS FOUND AT THE VEIN AROUND THE RADIAL PUNCTURE. NO OTHER ADVERSE CONSEQUENCES WERE REPORTED FOR THIS PATIENT.

    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 13359174

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention WIZDOM WIRE AND SPRINTER (2.0X20) BALLOON.