BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 4198207 · Received October 23, 2014

    Report

    Report Number
    3003742446-2014-00050
    Event Type
    Injury
    Date Received
    October 23, 2014
    Report Date
    November 6, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 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 (B)(6) 2000 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) 2004. 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. BEGINNING 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. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PATIENT WHO PROVIDED DETAILS OF THE DEVICES THAT WERE IMPLANTED. THE PATIENT READ OUT THE DETAILS FROM THE IMPLANT CARDS, ¿0H17E04BS¿ 1 CORDIS, IMPLANTED ON (B)(6) 2001, RCA DISTAL, (B)(4). THESE NUMBERS WERE NOT RECOGNIZED BY THE SYSTEM. THEN THERE WERE 2 MORE STENTS, (B)(4) (2), IMPLANTED ON AN UNSPECIFIED DATE PLACED IN THE SVG AND PDA. TWO ADDITIONAL STENTS, 04031A1103618, WERE PLACED IN THE LAD ON (B)(6) 2003. THERE WERE TWO MORE STENTS, 06941204539/(B)(4), THAT WERE PLACED IN THE PDA ON (B)(6) 2005. THE PATIENT WAS UNABLE TO FOLLOW UP WITH THE PHYSICIAN WHO IMPLANTED THE STENTS AS SHE LIVES IN ANOTHER TOWN. THE PRODUCTS REMAIN IMPLANTED AND ARE NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD FOR DEVICES WITH THE LOT NUMBERS A1103618 REVEALED THAT DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR EACH LOT NUMBER 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 IMPLANTING CORONARY ARTERY STENTS AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CORONARY ARTERY DISEASE. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. THIS IS ONE OF 10 REPORTS ASSOCIATED WITH THIS PATIENT THAT WERE SUBMITTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2014-00044, (3003742446-2014-00045- VOIDED AND NO FURTHER REPORTS FORTHCOMING UNDER THIS NUMBER), 3003742446-2014-00049, 3003742446-2014-00050, 3003742446-2014-00051, 3003742446-2014-00052, 3003742446-2014-00053, 3003742446-2014-00054, 3003742446-2014-00055 AND 3003742446-2014-00056.

    Additional Manufacturer Narrative · 1

    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 10 REPORTS ASSOCIATED WITH THIS PATIENT THAT WERE SUBMITTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2014-00044, (3003742446-2014-00045- VOIDED AND NO FURTHER REPORTS FORTHCOMING UNDER THIS NUMBER), 3003742446-2014-00049, 3003742446-2014-00050, 3003742446-2014-00051, 3003742446-2014-00052, 3003742446-2014-00053, 3003742446-2014-00054, 3003742446-2014-00055 AND 3003742446-2014-00056.

    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. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PATIENT WHO PROVIDED DETAILS OF THE DEVICES THAT WERE IMPLANTED. THE PATIENT READ OUT THE DETAILS FROM THE IMPLANT CARDS, ¿(B)(4)¿ 1 CORDIS, IMPLANTED ON (B)(6) 2001, RCA DISTAL, (B)(4). THESE NUMBERS WERE NOT RECOGNIZED BY THE SYSTEM. THEN THERE WERE 2 MORE STENTS, (B)(4) (2), IMPLANTED ON AN UNSPECIFIED DATE PLACED IN THE SVG AND PDA. TWO ADDITIONAL STENTS, (B)(4), WERE PLACED IN THE LAD ON (B)(6) 2003. THERE WERE TWO MORE STENTS, (B)(4), THAT WERE PLACED IN THE PDA ON (B)(6) 2005. THE PATIENT WAS UNABLE TO FOLLOW UP WITH THE PHYSICIAN WHO IMPLANTED THE STENTS AS SHE LIVES IN ANOTHER TOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676439 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS CORPORATION CXS18300 A1103618

    Patients

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