BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 786951 · Received November 21, 2006

    Report

    Report Number
    6000093-2006-02434
    Event Type
    Injury
    Date Received
    November 21, 2006
    Date of Event
    October 29, 2006
    Report Date
    October 29, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    po30025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H-6: THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED AND THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNKNOWN, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 385 DAYS AFTER IMPLANTATION OF A 2.5X20MM TAXUS EXPRESS2 DRUG ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE THE TARGET LESION WAS LOCATED IN THE PROXIMAL OBTUSE MARGINAL ARTERY (OM). A PRE-INTERVENTION STENOSIS WAS NOT REPORTED. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED WITH A 2.25X15MM MAVERICK BALLOON. A 2.25X20MM TAXUS STENT WAS DEPLOYED AT 16 ATM FOR 25 SECONDS IN THE REGION OF THE LESION. THE STENT WAS POST-DILATED WITH A 2.5X9MM MAVERICK MONORAIL BALLOON. A POST-INTERVENTION RESIDUAL STENOSIS WAS NOT REPORTED. THE PATIENT RECEIVED INTRA-CORONARY NITROGLYCERIN AND INTEGRILIN DURING THE PROCEDURE. COMPLICATIONS WERE REPORTED AS "NONE." THREE DAYS LATER , THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) ON THE MID OM. A PRE-INTERVENTION STENOSIS WAS NOT REPORTED. IT WAS NOT REPORTED THAT THE VESSEL WAS PRE-DILATED. A 2.5X28MM NON-BOSTON SCIENTIFIC STENT WAS DEPLOYED IN THE MID OM AT 14 ATM FOR 15 SECONDS. PTCA WAS PERFORMED ON THE PROXIMAL OM. A PRE-INTERVENTION RESTENOSIS PERCENTAGE WAS NOT REPORTED. A 2.5X8MM TAXUS STENT WAS DEPLOYED AT 16 ATM FOR 14 SECONDS IN THE REGION OF THE LESION. A POST-INTERVENTION RESIDUAL STENOSIS WAS NOT REPORTED. THE PATIENT RECEIVED NITROGLYCERIN AND HEPARIN DURING THE PROCEDURE. THERE WERE "NO COMPLICATIONS." THE PATIENT PRESENTED 385 DAYS AFTER THE INITIAL PROCEDURE, "EMERGENTLY" WITH "CHEST PAIN." ANGIOGRAPHIC IMAGING WAS PERFORMED. THE PHYSICIAN PROCEEDED WITH PCI ON THE 1ST OM. A PERCENTAGE OF IN-STENT RESTENOSIS WAS NOT REPORTED. A 2.25X12MM MAVERICK BALLOON WAS USED TO PERFORM PTCA ON THE VESSEL. THE BALLOON WAS INFLATED AT 10 ATM FOR 36 SECONDS. AFTER "CHECKING PATENCY OF THE ARTERY," A 2.75X16MM BARE METAL BOSTON SCIENTIFIC LIBERTE OVER THE WIRE STENT WAS DEPLOYED IN THE 1ST OM. THE VESSEL WAS CHECKED FOR PATENCY. A POST-INTERVENTION RESIDUAL STENOSIS WAS NOT REPORTED. THE PATIENT RECEIVED PLAVIX, ASPIRIN, ANGIOMAX, ATROPINE, DOPAMINE, AND NITROGLYCERIN DURING THE PROCEDURE. IT WAS NOT NOTED THAT THE PATIENT STATED "NO COMPLAINTS" AT THE END OF THE PROCEDURE. THERE WERE "NO COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT NIQ: STENT, CORONARY, DRUG ELUTING NIQ BOSTON SCIENTIFIC 2.5X20MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| R CORDIS REFLEX SOFT GUIDEWIRE-.014X175CM.