BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3171083 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03754
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THE UNKNOWN XIENCE V STENT MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. AGE ESTIMATED. DATE OF EVENT ESTIMATED AS 6-MONTH FOLLOW START DATE. DATE OF IMPLANT ESTIMATED AS 6 MONTHS PRIOR FOLLOW-UP START DATE. CONCOMITANT PRODUCT: ESTIMATED THERAPY DATE. ARTICLE REVIEWED (B)(4) 2013. 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. ARTICLE- 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.

    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 AUGUST 2010 AND NOVEMBER 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. CLINICAL OUTCOMES DURING THE 6-MONTH POST-IMPLANTATION FOLLOW-UP WERE AS FOLLOWS: INDIVIDUAL MALAPPOSED STENT STRUTS (N=109); INDIVIDUAL UNCOVERED STRUTS WITH MALAPPOSITION (N=23); INCOMPLETE STENT APPOSITION (ISA) (N=44). NO ADDITIONAL INFORMATION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270851 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR STENT: UNKNOWN XIENCE V