BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1490778 · Received October 2, 2009

    Report

    Report Number
    2024168-2009-01752
    Event Type
    Injury
    Date Received
    October 2, 2009
    Date of Event
    August 23, 2009
    Report Date
    September 8, 2009
    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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DISSECTION, AS LISTED IN THE PROMUS IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THIS KNOWN PATIENT EFFECT IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE IFU ALSO STATES: IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE PRODUCTS, IF ANY, CANNOT BE DETERMINED, THERE DOES NOT APPEAR TO BE AN INDICATION OF PRODUCT QUALITY DEFICIENCY. THE SECOND 2.5 X 12 MM PROMUS (PART 1009539-12B, LOT 9031061), IS BEING FILED UNDER THE SAME MFR#.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT IN 2009, A 3.5 X 12 MM PROMUS WAS IMPLANTED IN THE PROXIMAL LAD AND TWO 2.5 X 12 MM PROMUS STENTS WERE IMPLANTED AT THE PROXIMAL DIAGONAL/MID LAD BIFURCATION. DISTAL DISSECTIONS OCCURRED AT THE EDGE OF BOTH PROMUS STENTS AT THE BIFURCATION LESION; THEREFORE, TWO ADDITIONAL 2.5 X 08 MM PROMUS STENTS WERE IMPLANTED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9031061

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 2.5 X 12 MM PROMUS (PART 1009539-12B, LOT 9031061,| STENT: 3.5 X 12 MM PROMUS