BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2120447 · Received June 10, 2011

    Report

    Report Number
    2024168-2011-04112
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    February 14, 2011
    Report Date
    May 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A 2.75 X 28 MM XIENCE STENT IMPLANTED ON (B)(6) 2010. THE PATIENT RETURNED ON (B)(6) 2011 AND RESTENOSIS WAS NOTED IN THE XIENCE V STENT. THE PATIENT DECLINED TO HAVE A BYPASS SURGERY AND WAS TREATED WITH MEDICATIONS. AS OF (B)(6) 2011, THE PATIENT WAS STILL EXPERIENCING CHEST PAIN AND THE PHYSICIAN ADAPTED THE MEDICAL TREATMENT, ADDING MEDICATIONS FOR THE CHEST PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9090441

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R