BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 4113572 · Received September 24, 2014

    Report

    Report Number
    3003742446-2014-00045
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 9, 2014
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2008, FOLLOWING THE QUADRUPLE BYPASS, PATIENT WAS IN THE ICU ON A RESPIRATOR AND THE SURGEON WHO PERFORMED THE BYPASS YELLING AT HER FOR LETTING THE PREVIOUS SURGEON IMPLANT SO MANY STENTS WHICH MADE THE BYPASS ALMOST IMPOSSIBLE. PATIENT ADDITIONALLY REPORTED THAT SHE HAD THOUGHT THAT AFTER THE QUADRUPLE BYPASS ALL OF HER STENTS WOULD HAVE BEEN REMOVED BUT THEY WERE NOT AND SHE NOW HAS A WIRE IN HER CHEST VISIBLE ON X-RAY THAT PROHIBITS HER FROM GOING THROUGH CERTAIN METAL DETECTORS. BEGINNING ON (B)(6) 2014, PATIENT WAS DIAGNOSED WITH "DOUBLE" PNEUMONIA AND HER "O2 SATS" DROPPED, IT WAS NOT CLARIFIED IF PATIENT WAS HOSPITALIZED. PATIENT WAS PRESCRIBED LEVOFLOXACIN AND DEVELOPED AN UNSPECIFIED ALLERGY. AS TREATMENT FOR THE PNEUMONIA, ON (B)(6) 2014, PATIENT BEGAN USING OXYGEN AT NIGHT AND IN (B)(6) 2014, PATIENT WAS PRESCRIBED THE USE OF AN UNSPECIFIED NEBULIZER. PNEUMONIA RESOLVED WITH SEQUELAE OF CONGESTION, ON (B)(6) 2014 AND BEING A SHALLOW BREATHER, PATIENT HAS CONTINUED ON OXYGEN AT NIGHT, AND NEBULIZER TREATMENT WAS DISCONTINUED ON (B)(6) 2014. "THE OTHER DAY" PATIENT EXPERIENCED HER BLOOD PRESSURE MEDICATION NOT WORKING DESCRIBED AS A BLOOD PRESSURE OF 200/98, FOR WHICH PHYSICIAN WAS AWARE. NO FURTHER INFORMATION WAS AVAILABLE. PLEASE NOTE THAT THIS REPORT REPRESENTS NOTIFICATION OF A CYPHER STENT WITH UNKNOWN CATALOG AND LOT NUMBERS. THE EVENT DATE CHOSEN WAS FOR PURPOSES OF SUBMITTING THE REPORT SINCE THE EVENT DATES WERE NOT PROVIDED. THIS IS ONE OF TWO REPORTS ASSOCIATED WITH THIS PATIENT THAT WERE SUBMITTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2014-00044 AND 3003742446-2014-00045.

    Description of Event or Problem · 1

    A CYPHER PATIENT CALLED FOR STENT CARD REPLACEMENT AND ADDITIONALLY REPORTED ADVERSE EVENTS. ON U/U/U PATIENT EXPERIENCED AN UNKNOWN BLOCKAGE WHICH RESULTED IN TWO UNSPECIFIED BARE METAL STENTS BEING IMPLANTED IN AN UNKNOWN VESSEL ON 2000/U/U, ABOUT 14-YEARS AGO. DURING A 5-YEAR TIME PERIOD FROM ABOUT 2004-2009 PATIENT EXPERIENCED AN UNKNOWN NUMBER OF BLOCKAGES WHICH RESULTED IN 8 OR 9 CYPHER SIROLIMUS DRUG-ELUTING STENTS BEING IMPLANTED IN UNKNOWN VESSELS, DESCRIBED AS MAYBE THE CORONARY ARTERY BUT PATIENT WAS "NOT REALLY SURE". EACH CYPHER STENT PLACEMENT REQUIRED AN OVERNIGHT STAY UNTIL THE FACILITY BEGAN USING A VASOSEALER WHICH THEN MADE THE PROCEDURES AN OUT-PATIENT PROCEDURE. ON U/U/U, AFTER ONE OF THE CYPHER STENT IMPLANTS, PATIENT'S IMPLANTATION SITE OPENED AND BLED PROFUSELY AND AS TREATMENT THE DOCTOR APPLIED PRESSURE TO THE AREA UNTIL IT STOPPED BLEEDING. THIS WAS REPORTED BY THE PATIENT TO BE PRIOR TO THE USE OF THE "VASOSEALER". ON U/U/U ONE OF THE CYPHER STENT IMPLANTS, WAS "TRICKY" DESCRIBED AS ONE STENT BEING INSERTED THROUGH ANOTHER STENT. ON U/U/U AFTER THE "TRICKY" IMPLANT PATIENT REPORTED SHE "ALMOST DIED" WHICH WAS CLARIFIED AS A NURSE TOLD THE PATIENT THE DOCTOR "SAVED YOUR BACON" WHICH COULD NOT BE FURTHER CLARIFIED. ON (B)(6) 2007, PATIENT EXPERIENCED THE FEMORAL ARTERY "SHREDDING" DESCRIBED AS FROM BEING "CUT" SEVERAL TIMES DURING THE STENTING AND AS TREATMENT ANOTHER PHYSICIAN PERFORMED AN "ARTIFICIAL FEMORAL ARTERY", WHICH RESULTED IN A HOSPITALIZATION. CONSUMER REPORTED THAT SHE NOW QUESTIONS IF SHE NEEDED THAT MANY STENTS, DESCRIBED AS HAVING 1-2 STENTS PER YEAR DURING THE 5-YEAR TIME PERIOD. BEGINNING ON U/U/U PATIENT EXPERIENCED AN UNKNOWN EVENT WHICH RESULTED IN AN ATTEMPTED STENT PLACEMENT WHICH ENDED WITH THE PATIENT BEING TRANSFERRED FROM THE CATH LAB TO HAVE OPEN HEART SURGERY DESCRIBED AS A QUADRUPLE BYPASS ON (B)(6) 2008/05/04.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596171 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R