BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053642 · Received May 27, 2008

    Report

    Report Number
    9616099-2008-01403
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 6, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, AS OF TO DATE THE EVALUATION HAS NOT BEEN COMPLETED. 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

    INFLATION DIFFICULTY. THE REPORT RECEIVED INDICATED THAT DURING A DIRECT STENTING CORONARY PROCEDURE, THE 3.00X23MM CYPHER STENT DID NOT INFLATE; THE PROBLEM WAS IDENTIFIED WHILE TRYING TO INFLATE THE BALLOON IN THE LESION. AFTER IDENTIFYING THE PROBLEM, THE PHYSICIAN REMOVED THE DEVICE AND THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S STENT. THERE WAS NO REPORT OF COMPLICATIONS OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION INDICATED THAT DURING THE PROCEDURE, THE CONTRAST TO SALINE RATIO USED WAS 1:1. THE PRESSURE APPLIED WAS 6, 8 AND A MAXIMUM OF 10 ATMOSPHERES; HOWEVER, THE BALLOON DID NOT APPEAR TO INFLATE AT ANY TIME. THERE WERE NO LEAKAGES, KINKS OR DAMAGES NOTED ON THE DEVICE. THE DEVICE WAS PREPPED NORMALLY AND WITHOUT COMPLICATIONS. THE PROCEDURE INCLUDED TREATMENT OF THE DISTAL RIGHT CORONARY ARTERY; THE LESION WAS DESCRIBED AS TUBULAR.

    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 13349136

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR - BRACCO COMPANY AND B BRAUN INFLATION DEVICE| CONTRAST MEDIA USED WAS IOPAMADOL USP IOPAMANO 300