BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1871403 · Received October 15, 2010

    Report

    Report Number
    3003742446-2010-00364
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 20, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE PATIENT THROUGH THE MEDICAL AFFAIRS DEPARTMENT INDICATED THAT THE PATIENT HAD A CYPHER 3.5 X 13 MM STENT IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA) DUE TO A MILD HEART ATTACK AND A CORONARY ARTERY STRICTURE NEAR HER AORTA DURING THE INDEX PROCEDURE. THE PATIENT'S MEDICAL HISTORY INCLUDES: ALLERGY TO NARCOTIC PAIN MEDICATIONS; SPINAL FUSION; HYPERTENSION; OSTEOARTHRITIS; AND MYOCARDIAL INFARCTION (MI). TWENTY DAYS AFTER THE INDEX PROCEDURE, THE PATIENT REPORTED EXPERIENCING CHEST PAIN/PRESSURE WHICH ABATED THE NEXT DAY. TWO DAYS AFTER THE EVENT OF CHEST PAIN, THE PATIENT BECAME LIGHT-HEADED WHILE ON A TREADMILL AT CARDIAC REHABILITATION. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND A CARDIAC CATHETERIZATION WAS PERFORMED. THE PATIENT STATED THAT SHE WAS TOLD THAT HER PREVIOUSLY IMPLANTED CYPHER STENT HAD "MIGRATED ONE INCH" FROM WHERE IT HAD BEEN PLACED/IMPLANTED. AN ADDITIONAL CYPHER STENT WAS IMPLANTED IN THE RCA ALONG WITH "SOME HARDWARE TO KEEP IT IN PLACE." THE PATIENT WAS HOSPITALIZED OVERNIGHT. MULTIPLE ATTEMPTS TO CLARIFY THE EVENT WERE UNSUCCESSFUL. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS 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. IT IS OUR INTENTION TO REPORT CONSERVATIVELY WHEN INFORMATION IS NOT AVAILABLE; THEREFORE, THIS EVENT WILL BE CAPTURED AS STENT MIGRATION. STENT MIGRATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT PLACEMENT. IN CLINICAL PRACTICE, THE OPERATOR MUST DECIDE WHICH STENT IS MOST APPROPRIATE FOR A PARTICULAR TYPE OF LESION AND VESSEL ANATOMY. IN THIS CASE, THE VESSEL CHARACTERISTICS WERE UNKNOWN, THEREFORE, IT IS UNKNOWN IF THE STENT SIZE SELECTION WAS APPROPRIATE FOR THE SIZE OF THE VESSEL WHERE THE STENT WAS IMPLANTED. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT REPORTED. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE PATIENT/INITIAL REPORTER THROUGH THE MEDICAL AFFAIRS DEPARTMENT INDICATED THAT THE PATIENT HAD A CYPHER 3.5 X 13 MM STENT IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA) TARGET LESION DUE TO A MILD HEART ATTACK AND A CORONARY ARTERY STRICTURE NEAR HER AORTA DURING THE INDEX PROCEDURE. TWENTY DAYS AFTER THE INDEX PROCEDURE, THE PATIENT REPORTED EXPERIENCING CHEST PAIN/PRESSURE WHICH ABATED THE NEXT DAY. TWO DAYS AFTER THE EVENT OF CHEST PAIN, THE PATIENT BECAME LIGHT-HEADED WHILE ON A TREADMILL AT CARDIAC REHABILITATION. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND A CARDIAC CATHETERIZATION WAS PERFORMED. THE PATIENT STATED THAT SHE WAS TOLD THAT HER PREVIOUSLY IMPLANTED CYPHER STENT HAD MIGRATED ONE INCH FROM WHERE IT HAD BEEN PLACED/IMPLANTED. AN ADDITIONAL CYPHER STENT WAS IMPLANTED IN THE RCA ALONG WITH 'SOME HARDWARE TO KEEP IT IN PLACE'. THE PATIENT WAS HOSPITALIZED OVERNIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

    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) 15162572

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R