BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1033587 · Received April 23, 2008

    Report

    Report Number
    9616099-2008-01078
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    October 10, 2007
    Report Date
    March 28, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PROD IS DISTRIBUTED OUTSIDE THE US. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MFR REPORT NUMBER IS 9616099-2008-01079. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A MONTH POST-PROCEDURE, THE PT UNDERWENT A RE-PCI. IT IS UNK WHAT VESSEL WAS INVOLVED IN THE RE-PCI, THEREFORE, THIS WILL BE REPORTED AS A CORONARY RESTENOSIS. APPROX 2 MONTHS POST-PROCEDURE, THE PT EXPERIENCED NON-CARDIAC CHEST PAIN. THE REPORT IS FROM THE STUDY. THE PT WAS A MALE WITH 2-VESSEL DISEASE. ONE LESION WAS TREATED DURING THE INDEX PROCEDURE AND A STAGED PROCEDURE WAS PLANNED DUE TO TIME OR LOGISTICS. THE PT HAD A HISTORY OF OBESITY, HYPERTENSION, HYPERLIPIDEMIA, AND SMOKING. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE TARGET LESION WAS THE MID TO DISTAL RIGHT CORONARY ARTERY (RCA). VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 50MM. PRE-PROCEDURE STENOSIS WAS 100%. THE LESION WAS DE NOVO AND A TOTAL OCCLUSION. THE LESION WAS PRE-DILATED WITH A 2.5 X 20MM BALLOON AT 18 ATMS. TWO STENTS WERE IMPLANTED OVERLAPPING IN THE LESION. A CYPER WAS DEPLOYED AT 14 ATMS AND ANOTHER CYPHER WAS DEPLOYED AT 16 ATMS. POST-PROCEDURE STENOSIS WAS 0%. THE PT WAS DISCHARGED THE FOLLOWING DAY.

    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 13243927

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention DEVICES: 6FR GUIDING CATHETER| BETA BLOCKERS| ASPIRIN| CLOPIDOGREL| STATINS| 2.5 X 20 BALLOON| HEPARIN| MEDICATIONS: ACE INHIBITORS