BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3092596 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02770
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    December 1, 2010
    Report Date
    April 16, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF EVENT ESTIMATED AS STENT STRUTS WERE REVIEWED BEGINNING (B)(6) 2010. DATE OF IMPLANT ESTIMATED AS 1 MONTH PRIOR TO THE 1ST MONTH FOLLOW-UP OF (B)(6) 2010. IT IS INDICATED THAT THE DEVICES ARE NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORDS AND COMPLAINT HISTORIES COULD NOT BE CONDUCTED BECAUSE THE LOT IDENTIFICATION NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF ORAL ABSTRACT AS-081 FROM THE AMERICAN JOURNAL OF CARDIOLOGY APRIL 23-26, 2013 ANGIOPLASTY SUMMIT ABSTRACTS (ORAL): "SERIAL OPTICAL COHERENCE TOMOGRAPHY ASSESSMENT OF XIENCE V AND NOROBI STENTS AT 1- AND 6-MONTHS FOLLOW-UP". (SHOICHI KURAMITSU, MASASHI IWABUCHI, TAKENORI DOMEI, YOSHIO KAZUNO, SOICHIRO ENOMOTO, TORU MAZAKI, MAKOTO HYODO, SHINICHI SHIRAI, HIROYOSHI YOKOI, MASAKIYO NOBUYOSHI. KOKURA MEMORIAL HOSPITAL, KITAKYUSHU, JAPAN). IT WAS REPORTED THAT DURING A STUDY TO COMPARE NEOINTIMAL THICKNESS VIA OPTICAL COHERENCE TOMOGRAPHY (OCT) POST IMPLANTATION OF 18 XIENCE V STENTS IN 12 PATIENTS AND 12 NON-ABBOTT STENTS IN 9 PATIENTS (14 OUT OF 21 PATIENTS WERE MALE) BETWEEN DECEMBER 2010 AND JULY 2011: *OUT OF A TOTAL OF 2,449 XIENCE V INDIVIDUAL STENT STRUTS REVIEWED 1 MONTH POST-IMPLANTATION, 1.23% OF THE STRUTS WERE MALAPPOSED. *OUT OF A TOTAL OF 3,133 XIENCE V INDIVIDUAL STENT STRUTS REVIEWED 6 MONTHS POST-IMPLANTATION, 0.94% OF THE STRUTS WERE MALAPPOSED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193931 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR STENT: NOROBI