BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1981159 · Received February 8, 2011

    Report

    Report Number
    3003742446-2011-00054
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 1, 2008
    Report Date
    January 13, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 OF RECEIPT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER(S) IS/ARE 3003742446-2011-00054, 3003742446-2011-00055 AND 3003742446-2011-00056.

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPERIENCED RESTENOSIS OF THREE CYPHER STENTS IMPLANTED AT DIFFERENT TIMES. THE PATIENT HAS A MEDICAL HISTORY OF NKDA, MILD HEART ATTACK, SLEEP APNEA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), HIGH CHOLESTEROL, IRRITABLE BOWEL SYNDROME (IBS) AND CORONARY ARTERY DISEASE (CAD). A CYPHER STENT WAS PLACED IN THE "RIGHT CORONARY ARTERY" FOR A "60-70% BLOCKAGE." AFTER UNSPECIFIED ROUTINE TESTS WERE PERFORMED, THE PHYSICIAN FOUND A "BLOCKAGE IN THE PATIENT'S LEFT LEG." AS TREATMENT, PATIENT WAS HOSPITALIZED ON AND WAS SCHEDULED TO RECEIVE STENT PLACEMENT. PRIOR TO THIS SCHEDULED TREATMENT, UNSPECIFIED TESTING ADDITIONALLY REVEALED "FURTHER BLOCKAGE IN THE HEART." ON THE SAME HOSPITALIZATION, AS TREATMENT FOR THE "FURTHER BLOCKAGE IN THE HEART" A "QUADRUPLE BYPASS" WAS PERFORMED. ADDITIONALLY, A WALL STENT WAS PLACED IN THE ILIAC ARTERY AS TREATMENT FOR THE EVENT OF "BLOCKAGE IN THE PATIENT'S LEFT LEG." THE PATIENT ALSO REPORTED THAT DURING HOSPITALIZATION, ON 2008 HIS "HEMOGLOBIN DROPPED TO 5.3." PATIENT ADDITIONALLY STATED THAT SINCE THE "QUADRUPLE BYPASS, EVERY 3-5 MONTHS HE ENDS UP IN THE HOSPITAL AND HAS TO EITHER GET ANOTHER STENT PLACED, CLEANED, OR STENTS REPLACED." THE FOLLOWING YEAR, ANOTHER CYPHER STENT WAS PLACED IN AN UNKNOWN CARDIAC VESSEL FOR "FURTHER BLOCKAGE". A YEAR LATER, TWO PROMUS STENTS WERE PLACED IN UNKNOWN CARDIAC VESSELS FOR "FURTHER BLOCKAGE", A CYPHER STENT WAS PLACED IN AN UNKNOWN CARDIAC VESSEL FOR "FURTHER BLOCKAGE"AND A XIENCE STENT WAS PLACED IN AN UNKNOWN VESSEL AS TREATMENT FOR "FURTHER BLOCKAGE." EVENT OF "FURTHER BLOCKAGE" REMAINED ONGOING AS THE PATIENT STATED THAT HE CURRENTLY HAS "95% BLOCKAGE" IN AN UNSPECIFIED CARDIAC VESSEL. MULTIPLE ATTEMPTS TO CLARIFY ALL EVENTS WERE UNSUCCESSFUL. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. IT IS OUR INTENTION TO REPORT CONSERVATIVELY WHEN INFORMATION IS NOT AVAILABLE. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TYPE OF TREATMENT OF THE DISEASE PROCESS AND IT IS NOT A PREVENTION OR CURE OF THE PROGRESSION OF ATHEROSCLEROTIC ARTERY DISEASE. 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. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER(S) IS/ARE 3003742446-2011-00054, 3003742446-2011-00055 AND 3003742446-2011-00056.

    Description of Event or Problem · 1

    A CYPHER STENT WAS PLACED IN THE "RIGHT CORONARY ARTERY" FOR A "60-70% BLOCKAGE." AFTER UNSPECIFIED ROUTINE TESTS WERE PERFORMED, THE PHYSICIAN FOUND A "BLOCKAGE IN THE PATIENT'S LEFT LEG." AS TREATMENT, PATIENT WAS HOSPITALIZED ON 2008 AND WAS SCHEDULED TO RECEIVE STENT PLACEMENT. PRIOR TO THIS SCHEDULED TREATMENT, UNSPECIFIED TESTING ADDITIONALLY REVEALED "FURTHER BLOCKAGE IN THE HEART." ON THE SAME HOSPITALIZATION, 2008-U-U, AS TREATMENT FOR THE "FURTHER BLOCKAGE IN THE HEART" A "QUADRUPLE BYPASS" WAS PERFORMED. ADDITIONALLY, IN 2008, A WALL STENT WAS PLACED IN THE ILIAC ARTERY AS TREATMENT FOR THE EVENT OF "BLOCKAGE IN THE PATIENT'S LEFT LEG." EVENTS RESOLVED ON 2008. PATIENT ALSO REPORTED THAT DURING HOSPITALIZATION, ON 2008 HIS "HEMOGLOBIN DROPPED TO 5.3." AS TREATMENT, PATIENT WAS GIVEN BLOOD AND EVENT RESOLVED. TWO DAYS LATER, UNSPECIFIED TESTS DIAGNOSED THE PATIENT WITH "HEPATITIS C STAGE 2." TREATMENT, IF ANY WAS UNKNOWN. PATIENT WAS DISCHARGED FROM THE HOSPITAL. BEGINNING U-U-U, PATIENT EXPERIENCED "DEPRESSION." AS TREATMENT, PHYSICIAN PRESCRIBED WELLBUTRIN 75 MG BID AND VALIUM 5 MG AS NEEDED. PATIENT ADDITIONALLY STATED THAT SINCE THE "QUADRUPLE BYPASS, EVERY 3-5 MONTHS HE ENDS UP IN THE HOSPITAL AND HAS TO EITHER GET ANOTHER STENT PLACED, CLEANED, OR STENTS REPLACED." ON (B)(6) 2009, ANOTHER CYPHER STENT WAS PLACED IN AN UNKNOWN CARDIAC VESSEL FOR "FURTHER BLOCKAGE." EVENT RESOLVED ON 2009-U-U. ON (B)(6) 2010, TWO PROMUS STENTS WERE PLACED IN UNKNOWN CARDIAC VESSELS FOR "FURTHER BLOCKAGE." ON (B)(6) 2010, A CYPHER STENT WAS PLACED IN AN UNKNOWN CARDIAC VESSEL FOR "FURTHER BLOCKAGE" AND ON (B)(6) 2010 A XIENCE STENT WAS PLACED IN AN UNKNOWN VESSEL AS TREATMENT FOR "FURTHER BLOCKAGE." EVENT OF "FURTHER BLOCKAGE" REMAINED ONGOING AS THE PATIENT STATED THAT THIS MONTH ON (B)(6) 2011, HE HAS A "95% BLOCKAGE" IN AN UNSPECIFIED CARDIAC VESSEL.

    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 Y0306203

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R