BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1860034 · Received October 7, 2010

    Report

    Report Number
    9616099-2010-00757
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    May 5, 2008
    Report Date
    September 10, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    A (B)(6) MALE FROM THE (B)(4) STUDY EXPERIENCED A MYOCARDIAL INFARCTION DUE TO SUB-ACUTE THROMBOSIS THREE DAYS POST IMPLANTATION OF A CYPHER STENT. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED HIS RISK FOR MACE INCLUDES HYPERTENSION AND SMOKING. THE INDEX PROCEDURE WAS AN ELECTIVE CASE DUE TO ANGINA PECTORIS. THE TARGET LESION FOR THE PROCEDURE WAS THE PROXIMAL RCA. THE LESION WAS REPORTED TO BE: DE NOVO, 20 MM LENGTH, AND 2.5 MM VESSEL DIAMETER. IT WAS NOT KNOWN IF THE LESION WAS PRE-DILATED. A CYPHER 2.5 X 23 MM STENT WAS IMPLANTED AT 20 ATM. THE RATED BURST PRESSURE INDICATED IN THE IFU IS 16 ATMOSPHERES. IT WAS NOT KNOWN IF THE LESION WAS POST-DILATED. THE RESIDUAL STENOSIS WAS UNKNOWN. THE TIMI FLOWS PRE AND POST-PROCEDURE WERE UNKNOWN. IVUS WAS NOT DONE. POST-PROCEDURAL MEDICATIONS INCLUDED ASPIRIN AND PLAVIX. THREE DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS OBSERVED INSIDE THE PREVIOUSLY IMPLANTED CYPHER STENT. IVUS WAS NOT DONE. ASPIRATION OF THE THROMBUS AND BALLOON ANGIOPLASTY WAS DONE TO TREAT THE SUB-ACUTE THROMBOSIS (SAT). THE PATIENT DID FINE POST-PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THROMBOTIC EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR THROMBOTIC EVENTS INCLUDE THOSE WITH LONG LESIONS AND SMALL VESSEL DIAMETER. THE IFU WARNS THAT THE USE OF THIS DEVICE CARRIES THE ASSOCIATED RISKS OF SUB-ACUTE THROMBOSIS, VASCULAR COMPLICATIONS AND/OR BLEEDING EVENTS. INFLATION OF BALLOONS OVER THE RECOMMENDED RATED BURST PRESSURE MAY LEAD TO EXCESSIVE INTIMAL DAMAGE. THE PHYSICIAN'S COMMENT REGARDING A POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THAT IT WAS BECAUSE THE CYPHER STENT WAS UNDER-DILATED (AS NOTED BY CORONARY ANGIOGRAPHY). BASED ON THE INFORMATION PROVIDED, THERE ARE POSSIBLE PATIENT FACTORS (SMOKING), VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY CONTRIBUTED TO THIS EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PATIENT WAS ENROLLED IN A CLINICAL STUDY CALLED (B)(6). THE REPORT INDICATED THAT THE PATIENT HAD A CYPHER 2.5 X 23 MM STENT IMPLANTED SUCCESSFULLY IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) DURING THE STUDY INDEX PROCEDURE. THREE (3) DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS OBSERVED INSIDE THE PREVIOUSLY IMPLANTED CYPHER STENT. ASPIRATION OF THE THROMBUS AND BALLOON ANGIOPLASTY WAS DONE TO TREAT THE SUB-ACUTE THROMBOSIS (SAT). THE PHYSICIAN'S COMMENT REGARDING A POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THAT IT WAS BECAUSE THE CYPHER STENT WAS UNDER-DILATED. THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THE TARGET LESION FOR THE PROCEDURE WAS THE PROXIMAL RCA. THE LESION WAS REPORTED TO BE: DE NOVO, 20 MM LENGTH, AND 2.5 MM VESSEL DIAMETER. IT WAS NOT KNOWN IF THE LESION WAS PRE-DILATED. A CYPHER 2.5 X 23 MM STENT WAS IMPLANTED AT 20 ATM. IT WAS NOT KNOWN IF THE LESION WAS POST-DILATED. THE RESIDUAL STENOSIS WAS UNKNOWN. THE TIMI FLOWS PRE AND POST-PROCEDURE WERE UNKNOWN. IVUS WAS NOT DONE. IT WAS NOT KNOWN IF AN ACT WAS MEASURED.

    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 13359189

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R