BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3192333 · Received June 27, 2013

    Report

    Report Number
    3003742446-2013-00078
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED METFORMIN, METOPROLOL, MICARDIS, AND PLAVIX. THE EXACT EVENT DATE IS UNKNOWN HOWEVER IT WAS REPORTED THAT THE EVENT OCCURRED IN 2013. AS REPORTED FROM THE MEDICAL AFFAIRS, THE PATIENT HAD A CYPHER STENT IMPLANTED IN THE OM AND A CYPHER STENT IMPLANTED IN THE RCA DUE TO BLOCKAGES ON (B)(4) 2010. THE PATIENT¿S MEDICAL HISTORY IS SIGNIFICANT FOR NKDA, DIABETES, CAD; DENIES SMOKING, ALCOHOL AND DRUG ABUSE. APPROXIMATELY TWO YEARS LATER, THE PATIENT BEGAN EXPERIENCING INTERMITTENT CHEST PAIN, WEAKNESS AND FATIGUE ON EXERTION, SUCH AS WALKING, WHICH WAS RELIEVED WITH REST. IN ADDITION, THE PATIENT ALSO HAD AWAKENED IN THE MIDDLE OF THE NIGHT WITH CHEST DISCOMFORT ON ONE OCCASION. PATIENT BURPS FREQUENTLY DURING THESE EPISODES. PHYSICIAN WAS AWARE AND SUGGESTED THE CONSUMER TO GO TO THE IMPLANTING HOSPITAL 100 MILES AWAY, BUT CONSUMER REFUSED. EVENTS WERE ONGOING. ADDITIONAL INFORMATION THAT WAS OBTAINED DURING PHONE CONTACT INDICATED THAT THE PATIENT UNDERWENT 1 NEW STENT PLACEMENT IN AN UNKNOWN ARTERY. IT WAS UNKNOWN IF THE NEW LESION WAS IN THE SAME PREVIOUSLY TREATED VESSELS OR DIFFERENT. 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. REVIEW OF LOT 15195769 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00078 AND 3003742446-2013-00079.

    Description of Event or Problem · 1

    AS REPORTED FROM THE MEDICAL AFFAIRS, THE PATIENT HAD A CYPHER STENT IMPLANTED IN THE OM AND A CYPHER STENT IMPLANTED IN THE RCA DUE TO BLOCKAGES ON (B)(6) 2010. APPROXIMATELY TWO YEARS LATER, THE PATIENT BEGAN EXPERIENCING INTERMITTENT CHEST PAIN, WEAKNESS AND FATIGUE ON EXERTION, SUCH AS WALKING, WHICH WAS RELIEVED WITH REST. IN ADDITION, THE PATIENT ALSO HAD AWAKENED IN THE MIDDLE OF THE NIGHT WITH CHEST DISCOMFORT ON ONE OCCASION. PATIENT BURPS FREQUENTLY DURING THESE EPISODES. PHYSICIAN WAS AWARE AND SUGGESTED THE CONSUMER TO GO TO THE IMPLANTING HOSPITAL 100 MILES AWAY, BUT CONSUMER REFUSED. EVENTS WERE ONGOING. ADDITIONAL INFORMATION THAT WAS OBTAINED DURING PHONE CONTACT INDICATED THAT THE PATIENT UNDERWENT 1 NEW STENT PLACEMENT IN AN UNKNOWN ARTERY. IT WAS UNKNOWN IF THE NEW LESION WAS IN THE SAME PREVIOUSLY TREATED VESSELS OR DIFFERENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292321 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15195769

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention