BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1437990 · Received August 7, 2009

    Report

    Report Number
    2024168-2009-01416
    Event Type
    Injury
    Date Received
    August 7, 2009
    Date of Event
    July 9, 2009
    Report Date
    July 13, 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STENOSIS IS LISTED IN THE PROMUS IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. AS THERE WAS NO REPORTED PRODUCT MALFUNCTION AT THE TIME OF THE PROCEDURE, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A SDS QUALITY DEFICIENCY. IT SHOULD BE NOTED THAT THE PROMUS IFU STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER. REPORTEDLY, NO PRE-DILATATION WS PERFORMED PRIOR TO IMPLANTING THE PROMUS STENTS. A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE PROMUS SDS, IF ANY, CANNOT BE DETERMINED. THE SECOND PROMUS, (PART 1009527-18B, LOT 8012141), IS BEING FILED UNDER THE SAME MFR#.

    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 VIA A TRIAL THAT THE INDEX PROCEDURE TREATED TWO LESIONS. THE MID LAD WAS DE NOVO, BIFURCATED AND 80% STENOSISED. DIRECT STENTING WAS PERFORMED WITH THE 3.0 X 12 MM PROMUS STENT, RESULTING WITH 0% RESIDUAL STENOSIS. THE DISTAL LAD WAS DE NOVO, BIFURCATED AND 65% STENOSED. DIRECT STENTING WAS PERFORMED WITH A 2.5 X 18 MM PROMUS STENT, RESULTING IN 0% STENOSIS. THE PT HAD BEEN TAKING ASA AND PLAVIX PRE AND POST PROCEDURE. AT THE SIX MONTH FOLLOW UP THE PT REQUIRED TOTAL VESSEL REVASCULARIZATION. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R STENT: 2.5 X 18 MM PROMUS (PART 1009527-18B| LOT 8012141)