BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001490 · Received February 19, 2008

    Report

    Report Number
    9616099-2008-00390
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    August 11, 2007
    Report Date
    January 29, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN INDICATION FOR THE INTERVENTION WAS UNSTABLE ANGINA PECTORIS. THE FIRST LESION INITIALLY TREATED WAS IN THE PROXIMAL CIRCUMFLEX. IT WAS TYPE B2, NATIVE, RESTENOTIC (TAXUS STENT), TOTALLY OCCLUDED, IRREGULAR, READILY ACCESSIBLE AND ECCENTRIC. THE LESION HAD A REFERENCE VESSEL DIAMETER OF 2.5MM AND A LESION LENGTH OF 10MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 100%. THE LESION WAS PRE-DILATED WITH A 2.5X30MM BALLOON AT 13 ATM. A 2.5X18MM CYPHER SELECT PLUS STENT WAS ELECTIVELY IMPLANTED AT 15 ATM WITH SATISFACTORY RESULTS. THE SECOND LESION INITIALLY TREATED WAS IN THE DISTAL CIRCUMFLEX. IT WAS TYPE B2, NATIVE, RESTENOTIC (TAXUS STENT), TOTALLY OCCLUDED, IRREGULAR, READILY ACCESSIBLE AND ECCENTRIC. THE LESION HAD A REFERENCE VESSEL DIAMETER OF 2.5MM AND A LESION LENGTH OF 8MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 100%. A 2.5X13MM CYPHER SELECT PLUS STENT WAS ELECTIVELY IMPLANTED AT 18 ATM WITH SATISFACTORY RESULTS. THE STENT WAS POST-DILATED WITH A 3.0 X 9MM BALLOON AT 10 ATM, AS IT WAS NOT FULLY EXPANDED. POST-PROCEDURE DIAMETER STENOSIS WAS 0. DURING A 1-MONTH FOLLOW-UP PHONE CAL TO THE PT IN 2007, THE PT WAS ASYMPTOMATIC. THE MEDICATION TREATMENT OF ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS WAS ONGOING. DURING A 6 MONTH FOLLOW-UP ON FIVE MONTHS LATER, THE PT WAS ASYMPTOMATIC. THE MEDICATION TREATMENT OF ASPIRIN, CLOPIDOGREL, STATINS AND ACE INHIBITORS WAS ONGOING. THE PRODUCT REMAINS IMPLANTED IN THE PT THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS PT WAS ENROLLED IN THE STUDY FOR 3-VESSEL DISEASE. FOLLOWING IMPLANTATION OF THE FIRST STENT AT THE PROXIMAL CIRCUMFLEX THE PT EXPERIENCED INSUFFICIENT FLOW. THE STENT WAS POST-DILATED WITH A 3.0 X 9MM BALLOON AT 10 ATMS. POST-PROCEDURE DIAMETER STENOSIS WAS 0.

    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 I1106033

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 2.5 X 30MM BALLOON| 6 FR GUIDING CATHETER