BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 719538 · Received May 24, 2006

    Report

    Report Number
    6000093-2006-00945
    Event Type
    Injury
    Date Received
    May 24, 2006
    Date of Event
    November 30, 2005
    Report Date
    April 28, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LESS THAN 24 HOURS POST PROCEDURE, THE PATIENT EXPERIENCED A STENT THROMBOSIS (ST).THE INDEX PROCEDURE TREATED THE PROXIMAL LAD. THE LESION WAS 3 MM IN WIDTH, AND 20 MM IN LENGTH. THERE WAS A TOTAL OCCLUSION IN THE VESSEL. THE PATIENT RECEIVED BIVALIRUDIN (STUDY DRUG) DURING THE PROCEDURE. THE PHYSICIAN PRE-DILATED THE LESION PRIOR TO PLACING A 3.0X24.0MM TAXUS EXPRESS2 STENT. RESIDUAL STENOSIS WAS LESS THAN 5% POST DEPLOYMENT.APPROXIMATELY ONE HOUR AFTER THE INDEX PROCEDURE ENDED THE PATIENT WAS TAKEN TO THE ICU FOR CHEST PAIN (SPECIFICALLY, ANGINA PECTORIS). THE PATIENT ALSO HAD RECURRENT ST ELEVATION AT THE ANTERIOR WALL, PER EKG. THE PATIENT UNDERWENT ANGIOGRAPHY, AND THE STENT THROMBOSIS WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, USING A CONVENTIONAL BALLOON. THE PATIENT ALSO RECEIVED REO-PRO FOR 12 HOURS POST EVENT. THE EVENT RESOLVED AND THE PATIENT HAD A FULL RECOVERY THAT SAME DAY. IN THE OPINION OF THE PHYSICIAN, THERE WAS A POSSIBLE RELATIONSHIP BETWEEN THE STENT THROMBOSIS AND THE TAXUS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.0 X 24.0 MM 7499388

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention