BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4232645 · Received November 6, 2014

    Report

    Report Number
    2024168-2014-07261
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 28, 2014
    Report Date
    October 13, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD DATABASE FOR THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS. ANGINA, DYSPNEA, HYPERSENSITIVITY AND HYPOTENSION ARE LISTED IN THE XIENCE XPEDITION, XIENCE XPEDITION SMALL VESSEL, AND XIENCE XPEDITION LONG LENGTH, EVEROLIMUS ELUTING CORONARY STENT SYSTEMS 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 PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, A 3.0X18 MM OTW XIENCE XPEDITION STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY. ON (B)(6) 2014, THE PATIENT BEGAN EXPERIENCING SHORTNESS OF BREATH, CHEST PAIN, DIZZINESS, LOWER BLOOD PRESSURE, LOSS OF CONSCIOUSNESS AND AN ABSCESS ON THE FACE THAT HAVE BEEN GETTING PROGRESSIVELY WORSE. THE PATIENT HAS BEEN FOLLOWING THE DUAL ANTIPLATELET THERAPY, TAKING ASPIRIN AND 75 MG OF PLAVIX AS WELL AS A BETA-BLOCKER THAT WAS PRESCRIBED BY THE TREATING PHYSICIAN. REPORTEDLY, THE PATIENT HAS A KNOWN ALLERGY TO MOLYBDENUM THAT THE PHYSICIAN WAS AWARE OF PRIOR TO IMPLANTING THE XIENCE XPEDITION STENT. THE PATIENT HAS HAD ALL METAL DENTAL WORK REMOVED AND SCREWS THAT WERE PREVIOUSLY PLACED IN HER BACK REMOVED DUE TO THE MOLYBDENUM ALLERGY. THE PATIENT HAS AN APPOINTMENT WITH THE PHYSICIAN THAT IMPLANTED THE STENT ON (B)(6) 2014. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713583 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3112941

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other