BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1860800 · Received October 7, 2010

    Report

    Report Number
    9616099-2010-00770
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    April 14, 2008
    Report Date
    September 10, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS COMPLAINT IS FROM THE (B)(4) STUDY. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR HEART FAILURE AND A DECREASED IMMUNE-RESPONSE SYSTEM. THE TARGET LESION WAS MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS A DE NOVO, BUT OTHER LESION CHARACTERISTICS WERE UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS C. THE LESION LENGTH WAS APPROXIMATELY 30MM AND THE VESSEL DIAMETER WAS APPROXIMATELY 3.0MM. IT WAS UNKNOWN IF PRE-DILATION WAS CONDUCTED. CYPHER BX (3.0/33MM) WAS IMPLANTED AT 18ATM (INFLATION TIME UNKNOWN). IT IS UNKNOWN IF POST-DILATION WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS UNKNOWN. IVUS WAS NOT CONDUCTED. IT IS UNKNOWN IF ACT WAS MEASURED. FOUR DAYS POST-PROCEDURE, THE PATIENT DEVELOPED ST-ELEVATED MI AND VISITED THE HOSPITAL. CAG WAS CONDUCTED AND THROMBUS WAS OBSERVED INSIDE THE CYPHER BX. TO TREAT THE THROMBUS, POBA WAS CONDUCTED. THE PHYSICIAN COMMENTED THAT THE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE THE CYPHER BX WAS UNDER-DILATED. AT THE TIME OF THE EVENT THE PATIENT WAS ON AN ANTI-PLATELET REGIMEN OF ASPIRIN AND PLAVIX. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. SUB-ACUTE STENT THROMBOSIS AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THERE ARE MULTIPLE FACTORS THAT CAN AFFECT STENT UNDER-EXPANSION SUCH AS CALCIFICATION, TORTUOSITY, APPROPRIATE DEVICE SELECTION AND WHETHER THE LESION WAS PREPARED FOR THE IMPLANT OF THE DEVICE EITHER THROUGH PRE-DILATION OF THE VESSEL OR ROTATIONAL ATHERECTOMY OR IF NEED BE THROMBUS ASPIRATION AND IF THE STENT WAS POST-DILATED FOR OPTIMAL STENT WALL APPOSITION. WITH THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE WITH ANY CERTAINTY THE EXACT CAUSE FOR THE EVENT BUT THERE MAY HAVE BEEN VESSEL/LESION CHARACTERISTICS AND OR PROCEDURAL FACTORS THAT COULD HEAVE LEAD TO THE EVENTS. THERE IS NO INDICATION IN THE REPORTED EVENT OR THE DEVICE HISTORY REPORT OF A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM "RESTART". THE TARGET LESION WAS MID LAD. THE LESION WAS A DE NOVO, BUT OTHER LESION CHARACTERISTICS WERE UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS C. THE LESION LENGTH WAS APPROXIMATELY 30MM AND THE VESSEL DIAMETER WAS APPROXIMATELY 3.0MM. IT WAS AN ELECTIVE CASE. IT WAS UNKNOWN IF PRE-DILATION WAS CONDUCTED. CYPHER BX (3.0/33MM) WAS IMPLANTED AT 18ATM (INFLATION TIME UNKNOWN). IT IS UNKNOWN IF POST-DILATION WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS UNKNOWN. TIMI FLOW BEFORE AND AFTER THE PROCEDURE WERE UNKNOWN. IVUS WAS NOT CONDUCTED. IT IS UNKNOWN IF ACT WAS MEASURED. FOUR DAYS POST-PROCEDURE, THE PATIENT DEVELOPED ST-ELEVATED MI AND VISITED THE HOSPITAL. CAG WAS CONDUCTED AND THROMBUS WAS OBSERVED INSIDE THE CYPHER BX. TO TREAT THE THROMBUS, POBA WAS CONDUCTED. THE PHYSICIAN COMMENTED THAT THE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE THE CYPHER BX WAS UNDER-DILATED.

    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 13348385

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R MEDICINES: ASPIRIN, CLOPIDOGREL, HEPARIN