BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2864707 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07752
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    December 17, 2010
    Report Date
    November 12, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    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. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, DURING ROUTINE TESTING, THE PATIENT REPORTEDLY PRESENTED WITHOUT SYMPTOMS AND MYOCARDIAL SCINTIGRAPHY REVEALED ISCHEMIA AND 99% IN-STENT RESTENOSIS OF A 4.0 X 28 XIENCE V RX STENT THAT HAD BEEN IMPLANTED (B)(6) 2010, IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2011, INTRAVASCULAR ULTRASOUND (IVUS) DETECTED A STENT FRACTURE. THE IN-STENT RESTENOSIS WAS TREATED (B)(6) 2011, VIA DEPLOYMENT OF A NEW UNSPECIFIED DRUG-ELUTING STENT. THERE WERE NO ADVERSE PATIENT SEQUELAE. 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 9011541

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R