BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1730398 · Received June 18, 2010

    Report

    Report Number
    2024168-2010-01221
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    November 21, 2008
    Report Date
    April 20, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). THE SECOND PROMUS RX 3.0 X 23 MM (PART# 1009529-23B/LOT#8061041) IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF RESTENOSIS, AS LISTED IN THE PRODUCT RISK ASSESSMENT AND INSTRUCTIONS FOR USE (IFU), IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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.

    Description of Event or Problem · 1

    ADVERSE EVENT: RESTENOSIS. ONSET OF ADVERSE EVENT: TWO MONTHS POST IMPLANTATION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT THE STENOSED LESION WAS THE LEFT MAIN CORONARY ARTERY (LMCA) AND THE ORIGINAL STENOSED TARGET LESIONS TREATED WITH TWO PROMUS STENTS WERE THE MID LEFT ANTERIOR DESCENDING (LAD) AND THE PROXIMAL LAD. THE LMCA IS A NEW LESION THAT WAS TREATED WITH A BARE METAL STENT (NON-ABBOTT). THIS REPORTEDLY, IS THE SAME VESSEL; HOWEVER, NOT THE TARGET LESIONS ORIGINALLY TREATED WITH THE TWO PROMUS STENT IN 2008. THE TARGET LESION TREATED WITH THE BARE METAL STENT (NON-ABBOTT) WAS IN THE TARGET VESSEL BUT NOT IN THE TARGET LESION. THE RESTENOSED STENT IN THE LEFT MAIN SEGMENT IS ALSO RESTENOTIC IN THE TRANSITION ZONE TO THE STUDY STENT IN THE LAD SEGMENT. THEREFORE, A RELATION OF THIS RESTENOSIS TO THE STUDY STENT FOR ME SEEMS TO BE POSSIBLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8042961

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PROMUS RX 3.0 X 23 MM(PART#1009529-23B/LOT#8061041