BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 4430854 · Received January 19, 2015

    Report

    Report Number
    3003742446-2015-00006
    Event Type
    Injury
    Date Received
    January 19, 2015
    Report Date
    February 19, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 3003742446-2015-00005, 3003742446-2015-00006 AND 3003742446-2015-00007. COMPLAINT CONCLUSION: THE DAUGHTER OF A (B)(6) CYPHER PATIENT, WITH A HISTORY OF A HEART ATTACK IN 1990, CALLED FOR STENT CARD REPLACEMENT AND MEDICAL INFORMATION, AND ADDITIONALLY REPORTED ADVERSE EVENTS. ON (B)(6) 2006 PATIENT HAD A CYPHER STENT IMPLANTED IN AN UNSPECIFIED VESSEL FOR AN UNSPECIFIED REASON THOUGH IT MAY HAVE BEEN TO OPEN THE ARTERY FROM A PREVIOUS HEART ATTACK. IT WAS NOT OBTAINED IF PATIENT WAS HOSPITALIZED FOR THIS. ON U/U/U PATIENT EXPERIENCED AN UNKNOWN EVENT WHICH RESULTED IN A CYPHER STENT IMPLANTED IN AN UNSPECIFIED VESSEL ON U/U/U. IT WAS NOT OBTAINED IF PATIENT WAS HOSPITALIZED FOR THIS. ON U/U/U PATIENT EXPERIENCED AN UNKNOWN EVENT WHICH RESULTED IN A CYPHER STENT IMPLANTED IN AN UNSPECIFIED VESSEL ON U/U/U. IT WAS NOT OBTAINED IF PATIENT WAS HOSPITALIZED FOR THIS. REPORTER COULD NOT CLARIFY IF THE SECOND AND THIRD STENT WERE IMPLANTED AT THE TIME OF THE INITIAL CYPHER STENT OR AT A LATER DATE. IT WAS REPORTED THAT DAUGHTER ONLY REMEMBERS MOTHER HAVING ONE STENT YET SHE HAS A CARD WITH 3 LABELS AND 2 OF THE LABELS HAVE A DIFFERENT PHYSICIAN LISTED. ON U/U/U PATIENT WAS DIAGNOSED WITH ANGINA AND AS TREATMENT BEGAN ISOSORBIDE 60MG DAILY. ON U/U/U, MORE RECENTLY DESCRIBED AS POSSIBLY 2011, PATIENT EXPERIENCED AN UNKNOWN EVENT AND AS TREATMENT PATIENT BEGAN CLOPIDOGREL 75MG DAILY. REQUEST FOR FOLLOW UP COULD NOT BE OBTAINED AS DID NOT SPEAK TO THE PATIENT. REPORTER WAS A POOR HISTORIAN AND STATED SHE DID NOT HAVE ACCESS TO HER MOTHER'S RECORDS AT TIME OF CALL. SHE STATED THAT HER MOTHER IS HARD OF HEARING AND CANNOT SPEAK OVER THE PHONE. SHE STATED THAT SHE DOES KNOW THAT ONE STENTING WAS PERFORMED IN 2006 AND ONE IN 2009, BUT THE EXACT DATES ARE UNKNOWN. SHE ALSO DOES NOT KNOW WHETHER THE STENTS WERE IMPLANTED AT THREE SEPARATE TIMES, OR IF TWO WERE IMPLANTED AT ONE TIME. NO ADDITIONAL INFORMATION COULD BE OBTAINED. THE COMPLAINT PRODUCT WAS NOT RETURNED FOR ANALYSIS AS THE DEVICE REMAINS IMPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS AND THROMBOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, THE PATIENT¿S MEDICAL HISTORY AND THE PROGRESSION OF EXISTING CORONARY ARTERY DISEASE MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT DATE IS UNKNOWN. THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 3003742446-2015-00005, 3003742446-2015-00006 & 3003742446-2015-00007.

    Description of Event or Problem · 1

    THE DAUGHTER OF A CYPHER PATIENT CALLED FOR STENT CARD REPLACEMENT AND MEDICAL INFORMATION, AND ADDITIONALLY REPORTED ADVERSE EVENTS. ON (B)(6) 2006, PATIENT HAD A CYPHER STENT IMPLANTED IN AN UNSPECIFIED VESSEL FOR AN UNSPECIFIED REASON THOUGH IT MAY HAVE BEEN TO OPEN THE ARTERY FROM A PREVIOUS HEART ATTACK. IT WAS NOT OBTAINED IF PATIENT WAS HOSPITALIZED FOR THIS. ON U/U/U PATIENT EXPERIENCED AN UNKNOWN EVENT WHICH RESULTED IN A CYPHER STENT IMPLANTED IN AN UNSPECIFIED VESSEL ON U/U/U. IT WAS NOT OBTAINED IF PATIENT WAS HOSPITALIZED FOR THIS. ON U/U/U PATIENT EXPERIENCED AN UNKNOWN EVENT WHICH RESULTED IN A CYPHER STENT IMPLANTED IN AN UNSPECIFIED VESSEL ON U/U/U. IT WAS NOT OBTAINED IF PATIENT WAS HOSPITALIZED FOR THIS. REPORTER COULD NOT CLARIFY IF THE SECOND AND THIRD STENT WERE IMPLANTED AT THE TIME OF THE INITIAL CYPHER STENT OR AT A LATER DATE. IT WAS REPORTED THAT DAUGHTER ONLY REMEMBER'S MOTHER HAVING ONE STENT YET SHE HAS A CARD WITH 3 LABELS AND 2 OF THE LABELS HAVE A DIFFERENT PHYSICIAN LISTED. ON U/U/U PATIENT WAS DIAGNOSED WITH BREAST CANCER AND AS TREATMENT HAD A "SMALL AMOUNT OF TISSUE REMOVED". IT WAS NOT OBTAINED IF PATIENT WAS HOSPITALIZED FOR THIS. IT COULD NOT BE CLARIFIED IF THIS WAS BEFORE OR AFTER THE INITIAL CYPHER STENT WAS PLACED. ON U/U/U PATIENT WAS DIAGNOSED WITH ANGINA AND AS TREATMENT BEGAN ISOSORBIDE 60MG DAILY. ON U/U/U, BY 2009 BUT POSSIBLY IN 2007, PATIENT WAS DIAGNOSED WITH HIGH CHOLESTEROL AND AS TREATMENT BEGAN CRESTOR 40MG DAILY AND RAMIPRIL 10MG DAILY. BEGINNING ON U/U/U, BY 2009, PATIENT EXPERIENCED AN UNKNOWN EVENT WHICH RESULTED IN TREATMENT WITH CARVEDILOL 12.5MG DAILY WHICH WAS DESCRIBED AS BEING A BETA-BLOCKER. ON U/U/U, MORE RECENTLY DESCRIBED AS POSSIBLY 2011, PATIENT EXPERIENCED AN UNKNOWN EVENT AND AS TREATMENT PATIENT BEGAN CLOPIDOGREL 75MG DAILY. REQUEST FOR FOLLOW UP COULD NOT BE OBTAINED AS DID NOT SPEAK TO THE PATIENT. REPORTER WAS A POOR HISTORIAN AND STATED SHE DID NOT HAVE ACCESS TO HER MOTHER'S RECORDS AT TIME OF CALL. SHE STATED THAT HER MOTHER IS HARD OF HEARING AND CANNOT SPEAK OVER THE PHONE. SHE STATED THAT SHE DOES KNOW THAT ONE STENTING WAS PERFORMED IN 2006 AND ONE IN 2009, BUT THE EXACT DATES ARE UNKNOWN. SHE ALSO DOES NOT KNOW WHETHER THE STENTS WERE IMPLANTED AT THREE SEPARATE TIMES, OR IF TWO WERE IMPLANTED AT ONE TIME. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43131 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS CORPORATION A0606063

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Life Threatening| R