BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1801442 · Received August 16, 2010

    Report

    Report Number
    3003742446-2010-00290
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    March 17, 2010
    Report Date
    April 9, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BEING UNREPORTED, AS BASED ON THE ADDITIONAL INFORMATION THAT WAS RECEIVED, THERE WAS NO ADVERSE EVENT ASSOCIATED WITH OUR PRODUCTS. THE ADDITIONAL INFORMATION THAT WAS RECEIVED STATED THAT THE LESION THAT WAS TREATED POST PROCEDURE WAS IN THE PROXIMAL LEFT ANTERIOR DESCENDING BRANCH. A 2.5 X 28MM CYPHER STENT WAS IMPLANTED TO TREAT THIS LESION. IT WAS ALSO NOTED THAT ANGIOGRAPHY CONFIRMED THAT ALL OF THE STENTS IMPLANTED DURING THE INDEX PROCEDURE WERE PATENT.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REFLECTS FOUR PRODUCTS WITH THE SAME UNKNOWN CATALOG AND LOT NUMBERS. INFORMATION RECEIVED FROM (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND POSSIBLE RESTENOSIS AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR DIABETES, HYPERTENSION, A TRANSIENT ISCHEMIC ATTACK, PREVIOUS PERCUTANEOUS REVASCULARIZATION, CORONARY ARTERY BYPASS GRAFT SURGERY AND PREVIOUS MI. THE PATIENT WAS ENROLLED IN THE STUDY WITH LESIONS IN THE PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY (RCA). THE PATIENT HAD A TOTAL OF FOUR UNKNOWN CYPHER STENTS PLACED IN THE RCA. ONE STENT WAS IMPLANTED IN THE DISTAL, TWO IN THE MID AND ONE IN THE PROXIMAL. THERE IS NO OTHER PROCEDURAL INFORMATION AVAILABLE BUT THE REPORTED RESIDUAL STENOSIS WAS 0%. APPROXIMATELY TEN WEEKS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SUBSTERNAL CHEST PAIN. THE PATIENT WAS FOUND TO HAVE A NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WITH POSITIVE TROPONIN (DATES, UNITS AND REFERENCE RANGES NOT PROVIDED). THE PATIENT UNDERWENT A CARDIAC CATHETERIZATION AND RECEIVED A DRUG ELUTING STENT TO AN UNKNOWN VESSEL. ONE DAY LATER, THE EVENT OF NSTEMI WITH POSITIVE TROPONIN WAS CONSIDERED RESOLVED AND THE PATIENT RECOVERED. TWO DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IN THE INVESTIGATOR'S OPINION, THE EVENT OF NSTEMI WITH POSITIVE TROPONIN WAS CONSIDERED MODERATE IN INTENSITY, UNLIKELY RELATED TO THE STUDY MEDICATION, UNLIKELY RELATED TO THE STUDY DEVICE AND UNLIKELY RELATED TO THE STUDY PROCEDURE. THE PATIENT'S MEDICATIONS INCLUDED 600MG OF CLOPIDOGREL PERI-PROCEDURE, 75MG DAILY DOSING OF CLOPIDOGREL AND 325MG DOSING OF ASPIRIN. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. RESTENOSIS AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND THE PROGRESSION OF DISEASE. WITH THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO AN EXACT CAUSE FOR THE EVENT BUT THE PATIENT'S EXTENSIVE MEDICAL HISTORY MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    APPROXIMATELY TEN WEEKS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SUBSTERNAL CHEST PAIN. THE PATIENT WAS FOUND TO HAVE A NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WITH POSITIVE TROPONIN (DATES, UNITS AND REFERENCE RANGES NOT PROVIDED). THE PATIENT UNDERWENT A CARDIAC CATHETERIZATION AND RECEIVED A DRUG ELUTING STENT (CASS SITE UNKNOWN). ONE DAY LATER, THE EVENT OF NSTEMI WITH POSITIVE TROPONIN WAS CONSIDERED RESOLVED AND THE PATIENT RECOVERED. TWO DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IN THE INVESTIGATOR'S OPINION, THE EVENT OF NSTEMI WITH POSITIVE TROPONIN WAS CONSIDERED MODERATE IN INTENSITY, UNLIKELY RELATED TO THE STUDY MEDICATION, UNLIKELY RELATED TO THE STUDY DEVICE AND UNLIKELY RELATED TO THE STUDY PROCEDURE. THE PATIENT WAS ENROLLED IN (B)(4) STUDY WITH LESIONS IN THE PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY (RCA). THE PATIENT HAD FOUR CYPHER STENTS IMPLANTED; ON IN THE DISTAL RCA, TWO IN THE MID RCA AND ONE IN THE PROXIMAL RCA. POST STENT DEPLOYMENT RESIDUAL STENOSIS WAS 0%. THE PATIENT;S MEDICATIONS INCLUDED 600MG OF CLOPIDOGREL PERI-PROCEDURE, 75MG DAILY DOSING OF CLOPIDOGREL AND 325MG DOSING OF ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention