BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1231848 · Received November 12, 2008

    Report

    Report Number
    2024168-2008-01139
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 14, 2008
    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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. RESTENOSIS, AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE, IS A KNOWN RISK ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION AT THE TIME OF THE STENT IMPLANT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IN THIS CASE, IT IS LIKELY THAT THE HOSPITALIZATION IS A SECONDARY EFFECT OF THE STENOSIS. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE PROMUS STENT WAS IMPLANTED TO TREAT RESTENOSIS OF A BARE METAL STENT (BMS) IN 2008, THE LEFT ANTERIOR DESCENDING (LAD). THE PT RETURNED TO THE CATH LAB THREE MONTHS LATER, AND IN-STENT RESTENOSIS WAS FOUND THROUGHOUT THE STENT. THE PROMUS STENT SUBSEQUENTLY RESTENOSED AND ANGIOPLASTY WAS PERFORMED ON THE SAME DAY. THE PT WAS FINE AFTER THE PROCEDURE, THERE WERE NO PT EFFECTS. NO ADD'L EVENT OR PT INFO IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORP 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 NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8041061

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R