BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1906375 · Received November 23, 2010

    Report

    Report Number
    2024168-2010-02505
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 29, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED RE-STENOSIS IS LISTED IN THE INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE 3.0 X 28 MM PROMUS (1009541-28B/0020341), IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT UNDERWENT PERCUTANEOUS CORONARY ANGIOPLASTY IN THE RIGHT CORONARY ARTERY (RCA), DURING WHICH AT TOTAL OF FIVE PROMUS STENTS WERE IMPLANTED, ONE IN THE OSTIAL RCA, ONE IN THE PROXIMAL RCA, TWO IN THE MID RCA AND ONE IN THE DISTAL RCA. THE PROCEDURE WAS SUCCESSFUL. ON (B)(6) 2010, THE PATIENT WAS COMPLAINING OF CHEST PAIN AND A CARDIAC CATHETERIZATION WAS RECOMMENDED. DURING THE CATH PROCEDURE ON (B)(6) 2010, THE TWO PROMUS STENTS IN THE MID RCA WERE FOUND TO BE 75% RESTENOSED, THE REMAINDER OF THE STENTS IMPLANTED IN THE RCA WERE PATENT. THE RESTENOSIS WAS TREATED WITH THE PLACEMENT OF A NON-ABBOTT STENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-CLONMEL 0020341

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R