BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 651748 · Received December 8, 2005

    Report

    Report Number
    3003742446-2005-01912
    Event Type
    Injury
    Date Received
    December 8, 2005
    Date of Event
    September 14, 2005
    Report Date
    December 8, 2005
    Manufacturer
    CORDIS LLC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY FIVE (5) MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT HAD RECURRING ANGINA. CORONARY ANGIOGRAPHY DEMONSTRATED RESTENOSIS OF THE PREVIOUSLY IMPLANTED CYPHER STENTS. THE RESTENOSIS WAS NOT TREATED BY PERCUTANEOUS CORONARY INTERVENTION (PCI) BUT BY MEDICAL THERAPY. THE INDEX PROCEDURE WAS CLASSIFIED AS AN URGENT PROCEDURE WITH THE INDICATION BEING UNSTABLE ANGINA. THE EJECTION FRACTION (EF) WAS UNKNOWN. THE PATIENT WAS FOUND TO HAVE GREATER THAN 50% (>50%) IN THREE (3) VESSELS: THE RIGHT CORONARY ARTERY (RCA) THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE CIRCUMFLEX. TWO TARGER LESIONS WERE TREATED IN THE INDEX PROCEDURE. LESION #1-1: THE TARGET LESION WAS THE PROXIMAL PORTION OF THE SAPHENOUS VEIN GRAFT (SVG) TO THE LEFT CIRCUMFLEX THE LESION WAS REPORTED TO BE :DE NOVE, A SVG, A TOTAL (100%) OCCLUSION, NOT BIFURCATED, LITTLE OR NO CALCIUM PRESENT, 4.0 MM IN DIAMETER, AND 70MM IN LENGTH. LESION TREATMENT INCLUDED THE USE OF STENTS AND OTHER INTERVENTIONAL DEVICE(S). TWO 5.5 MM MAGIC WALL STENTS (BARE METAL STENTS - BMS) WERE DEPLOYED BY DIRECT STENTING IN OVERLAPPING FASHION. ANGIOGRAPHIC SUCCES WAS ACHIEVED. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE-PROCEDURE WAS TIMI 0 AND POST-PROCEDURE TIMI 3. NO PROCEDURAL OR DEVICE COMPLICATIONS WERE REPORTED. LESION #1-2: THE TARGET LESION WAS THE DISTAL PORTION OF THE SVG TO THE DISTAL LEFT CIRCUMFLEX. THE LESION WAS REPORTED TO BE :DE NOVE, A SVG, A TOTAL (100%) OCCLUSION , NOT BIFURCATED, LITTLE OR NO CALCIUM PRESENT, 3.5MM IN DIAMETER, AND 30MMIN LENGTH. LESION TREATMENT INCLUDED THE USE OF STENT(S). TWO (2) CYPHER STENTS, A 3.5/33 MM AND A 3.5/8MM, IN OVERLAPPING FASHION. ANGIOGRAPHIC SUCCESS WAS ACHIEVED. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE-PROCEDURE WAS TIMI 0 POST-PROCEDURE TIMI 3. NO PROCEDURAL OR DEVICE COMPLICATIONS WERE REPORTED. PRE-PROCEDURE MEDICATIONS WERE: ASPIRIN, BETA-BLOCKER, ACE INHIBITORS, AND STATINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG ELUTING STENT NIQ CORDIS LLC NA 40205851

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R