BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3171109 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03750
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    August 1, 2010
    Report Date
    May 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    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. IT WAS ALSO REPORTED THAT WHILE MOST STENT THROMBOSIS OCCURS WITHIN A YEAR OF IMPLANTATION, LATE OR VERY LATE STENT THROMBOSIS HAS BEEN SHOWN TO INCREASE AT AN ANNUAL RATE OF 0.4% TO 0.6% FOR UP TO 4 YEARS AFTER 1ST GENERATION DRUG-ELUTING STENT DEPLOYMENT. NO ADDITIONAL INFORMATION WAS NOTED. THE UNKNOWN PROMUS STENT MENTIONED IN IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. AGE ESTIMATED. MAJORITY GENDER. DATE OF EVENT ESTIMATED AS 6-MONTH FOLLOW START DATE. DATE OF IMPLANT ESTIMATED AS 6 MONTHS PRIOR FOLLOW-UP START DATE. ESTIMATED THERAPY DATE. ARTICLE REVIEWED 05/20/2013. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ISCHEMIA, THROMBOSIS, AND STENOSIS/RESTENOSIS ARE LISTED IN THE (B)(4) XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE FROM THE INTERNATIONAL JOURNAL OF CARDIOLOGY 166 (2013) 181-186: "SIX-MONTH FOLLOW-UP EVALUATION FOR EVEROLIMUS-ELUTING STENTS BY INTRACORONARY OPTICAL COHERENCE TOMOGRAPHY: COMPARISON WITH PACLITAXEL-ELUTING STENTS". (BY: MASAMICHI TAKANO, DAISUKE MURAKAMI, MASANORI YAMAMOTO, OSAMU KURIHARA, KOJI MURAI, TORU INAMI, NAKAHISA KIMATA, TAKAYOSHI OHBA, YOSHIHIKO SEINO, AND KYOICHI MIZUNO. IT WAS REPORTED THAT BETWEEN (B)(6) 2010, PROSPECTIVE INTRACORONARY OPTICAL COHERENCE TOMOGRAPHY (OCT) AND ANGIOGRAPHIC FOLLOW-UP EXAMINATIONS WERE PERFORMED FOR 21 PATIENTS THAT HAD RECEIVED EITHER A XIENCE V OR PROMUS STENT DEPLOYED AT A MEAN MAXIMUM INFLATION PRESSURE OF 15 ATMOSPHERES 6 MONTHS PRIOR, WITH STENTS IMPLANTED IN THE FOLLOWING CORONARY ARTERY LOCATIONS: LEFT ANTERIOR DESCENDING (11), LEFT CIRCUMFLEX (2), AND RIGHT CORONARY ARTERY (8) WITH 2 CHRONIC TOTAL OCCLUSIONS AND 4 CALCIFIED LESIONS. POST-DILATATION WAS PERFORMED WITH 20 OF THE STENTS. DURING THE 6-MONTH POST-IMPLANTATION FOLLOW-UP, STENT THROMBOSIS WAS DETECTED IN (B)(4) OF THE PATIENTS. IN-STENT RESTENOSIS APPEARED IN ONE PATIENT WHO CONSEQUENTLY RECEIVED TARGET LESION REVASCULARIZATION BY BALLOON ANGIOPLASTY BECAUSE OF SEVERE RESTENOSIS WITH EVIDENCE OF MYOCARDIAL ISCHEMIA. NO OTHER MAJOR ADVERSE CARDIAC EVENTS OCCURRED DURING THE FOLLOW-UP PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271704 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R STENT: UNKNOWN PROMUS