BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3252888 · Received July 29, 2013

    Report

    Report Number
    3003742446-2013-00092
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 29, 2006
    Report Date
    June 28, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED AMILORIDE, ASPIRIN, AND TRAMADOL. THIS REPORT CONTAINS INFORMATION FOR 4 PRODUCT DEVICES (OUT OF 5) ASSOCIATED WITH HYPERSENSITIVITY COMPLAINT. A PATIENT CALLED FOR MEDICAL INFORMATION AND REPORTED THE FOLLOWING, ON 2006; THE PATIENT HAD FOUR CYPHER STENTS PLACED IN AN UNKNOWN VESSEL DUE TO "BYPASSES CLOSED". DURING STENT PLACEMENT, A FIFTH UNSPECIFIED STENT WAS "LOST" DURING THE PROCEDURE. ON 2006, X-RAYS CONFIRMED "LOST" STENT IN "LOWER GROIN AREA ON THE RIGHT SIDE." IT WAS NOT ASKED IF EVENT EXTENDED HOSPITALIZATION. ON 2006, THE PATIENT EXPERIENCED AN "AUTOIMMUNE SITUATION", WITH BODY ACHES "LIKE A GIANT TOOTH ACHE", WHICH WAS CONFIRMED BY UNSPECIFIED BLOOD WORK. TREATMENT INCLUDED PLAQUINIL AND STEROIDS. "AUTOIMMUNE SITUATION" ABATED FROM UNTIL (B)(6) 2013, WHEN BODY ACHES RETURNED, AND WAS AGAIN CONFIRMED BY BLOOD WORK, AND HER PHYSICIAN FELT WAS RELATED TO STENTS. TREATMENT INCLUDED PLAQUINIL AND UNSPECIFIED STEROIDS, WHICH THE PATIENT DISCONTINUED ON 2013. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR CARDIOVASCULAR DISEASE, HYPERTENSION, HYPERLIPIDEMIA AND EDEMA. THE PATIENT HAS NOT ANSWERED OR RESPONDED TO PHONE CALLS REQUESTING MORE INFORMATION. THE STERILE LOT NUMBERS FOR THE DEVICES IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. ALLERGIC AND/OR IMMUNE REACTIONS TO BARE METAL AND DRUG ELUTING IS A KNOWN POTENTIAL REACTION TO THE IMPLANTATION OF METAL WITHIN THE BODY. MOST STENTS, BOTH BARE METAL AND DRUG ELUTING, ARE MADE WITH A METAL ALLOY, EITHER STAINLESS STEEL OR COBALT-CHROMIUM, BUT ALL CONTAIN NICKEL. NICKEL IS A METAL THAT A CERTAIN PERCENTAGE OF THE POPULATION IS ALLERGIC TO. WHETHER OR NOT THE SMALL AMOUNT OF NICKEL CAN CAUSE SIGNIFICANT REACTIONS HAS NOT BEEN WIDELY STUDIED. REVIEW OF THE LIMITED INFORMATION DOES NOT ALLOW FOR AN EDUCATED ASSESSMENT OF THE POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED EVENT. STENT DISLODGEMENT IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. WITH THE VERY LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE FOR THE REPORTED INFORMATION. THERE IS NOTHING TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. THIS IS ONE OF TWO REPORTS ASSOCIATED WITH REPORTED EVENTS IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00092 AND 3003742446-2013-00093.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE MEDICAL AFFAIRS INDICATED THAT ON (B)(6) 2006, THE PATIENT HAD FOUR CYPHER STENTS PLACED IN UNKNOWN VESSELS DUE TO "BYPASS CLOSED". DURING STENT PLACEMENT, A FIFTH UNSPECIFIED STENT WAS LOST. AND X-RAYS CONFIRMED "LOST" STENT WAS IN THE "LOWER GROIN AREA ON THE RIGHT SIDE." IN 2006, THE PATIENT EXPERIENCED AN "AUTOIMMUNE SITUATION" WITH BODY ACHES AND "LIKE A GIANT TOOTH ACHE", WHICH WAS CONFIRMED BY UNSPECIFIED BLOOD WORK. TREATMENT INCLUDED PLAQUINIL AND STEROIDS. THE AUTOIMMUNE SITUATION ABATED SINCE 2006 THROUGH (B)(6) 2013 BUT, BODY ACHES RETURNED, AND WAS AGAIN CONFIRMED BY BLOOD WORK, AND THE PHYSICIAN FELT IT WAS RELATED TO STENTS. NO ADDITIONAL INFORMATION SURROUNDING TO THE EVENT IS PROVIDED. TREATMENT INCLUDED PLAQUINIL AND UNSPECIFIED STEROIDS. PATIENT DISCONTINUED THE USE IN 2013. NO ADD INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353780 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR