BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3211120 · Received July 8, 2013

    Report

    Report Number
    2024168-2013-04265
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DESCRIPTION CONTINUED: ALL SYMPTOMS HAVE SUBSIDED WITH THE EXCEPTION OF SHORTNESS OF BREATH, WHICH IS NOT BEING TREATED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT PRODUCTS: STENT: 2.5X12 RX XIENCE XPEDITION (LOT NUMBER 3010441). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF DYSPNEA, EMBOLISM, AND HYPERTENSION ARE LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE IF ANY COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER RECEIVING A 2.25X28 RX XIENCE XPEDITION STENT AND A 2.5X12 RX XIENCE XPEDITION STENT IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY ON (B)(6) 2013 AT (B)(6), THE PATIENT BEGAN TO EXPERIENCE NUMBNESS THROUGHOUT THE BODY AND SHORTNESS OF BREATH ON (B)(6) 2013. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2013 AND STAYED OVERNIGHT FOR DIAGNOSTIC TESTS. WHILE THE PATIENT HAS A HISTORY OF HYPERTENSION AND REPORTEDLY HAS AN ALLERGY TO HYPERTENSION MEDICATIONS, THE BLOOD PRESSURE WAS NOTED TO HAVE SPIKED. A CHEST X-RAY REVEALED NO INDICATION OF A HEART ISSUE AND, THOUGH CARDIAC ENZYMES WERE SLIGHTLY ELEVATED, THE SLIGHT ENZYME ELEVATION WAS NOT CONSIDERED SIGNIFICANT BY ATTENDING PHYSICIAN. THE PATIENT WAS DISCHARGED (B)(6) 2013 WITH CLONIDINE BLOOD PRESSURE MEDICATION PRESCRIBED. REPORTEDLY, THE PATIENT HAD RECEIVED A METAL-ON-METAL HIP REPLACEMENT SOMETIME BETWEEN 2005 AND 2006 AND REQUIRED ANOTHER HIP REPLACEMENT SURGERY (B)(6) 2012 DUE TO COBALT POISONING; SHAVINGS HAD BEEN RELEASED IN THE BLOODSTREAM FROM THE INITIAL HIP REPLACEMENT AND THE PATIENT IS VERY CONCERNED THAT THE SHAVINGS MAY BE ATTRACTED BY, AND COLLECT IN, THE RECENTLY PLACED RX XIENCE XPEDITION STENTS, AND FEELS THAT THIS MAY BE THE REASON FOR THE SHORTNESS OF BREATH, BLOOD PRESSURE ELEVATION, NUMBNESS, AND ELEVATED CARDIAC ENZYMES THAT OCCURRED (B)(6) 2013. COBALT HAS BEEN COMING THROUGH PATIENT SKIN AND NAILS SINCE THE INITIAL HIP REPLACEMENT. SINCE THE INITIAL HIP REPLACEMENT, THE PATIENT HAS BEEN, AND IS CURRENTLY BEING, TREATED VIA CHELATION THERAPY TO REMOVE METAL FROM THE BLOODSTREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309915 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2111941

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R