BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 720833 · Received May 26, 2006

    Report

    Report Number
    6000093-2006-00980
    Event Type
    Injury
    Date Received
    May 26, 2006
    Date of Event
    April 18, 2006
    Report Date
    April 27, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NINE DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THERE WAS THROMBOSIS. THE PATIENT WAS TREATED WITH HEART CATHETERIZATION DUE TO CHEST PAIN AND UNSTABLE ANGINA. THE LESION IN THE SVG GRAFT FROM THE DIAGONAL TO THE OBTUSE MARGINAL (OM) WAS PREDILATED USING A SPRINTER 1.5X12 MM BALLOON INFLATED TO 14 ATMOSPHERES FOR 15 SECONDS. A 3.0X12MM TAXUS2 STENT WAS DEPLOYED TO 14 ATMOSPHERES FOR 30 SECONDS. THE STENT BALLOON WAS THEN RE-INFLATED TO 12 ATMOSPHERES FOR 20 SECONDS. IN THE MID LAD THE STENT BALLOON WAS REINFLATED TO 14 ATOMOSPHERES FOR 20 SECONDS. IN THE PROXIMAL LAD A QUANTUM MAVERICK BALLOON SIZE 2.5X15MM WAS INFLATED TO 20 ATMOSPHERES FOR 20 SECONDS AND A SPRINTER BALLOON SIZE 3.5X15MM WAS INFLATED TO 11 ATMOSPHERES FOR 20 SECONDS IN THE MID LAD. A 3.5X32MM TAXUS2 DRUG ELUTING STENT WAS DEPLOYED IN THE PROXIMAL LAD. PATIENT WAS STABLE FOLLOWING THE PROCEDURE. MEDICATIONS RECEIVED WERE ASPIRIN, BETA BLOCKER AND PLAVIX. NINE DAYS FOLLOWING THE PROCEDURE THE PATIENT RETURNED TO THE HOSPITAL WITH CHEST PAIN AND THROMBOSIS WAS FOUND IN THE LAD DIAGONAL STENT. THIS WAS TREATED AS FOLLOWS. A QUANTRUM MAVERICK BALLOON SIZE 3.0X12MM WAS INFLATED TO 14 ATMOSPHERES FOR 14 SECONDS. A SPRINTER BALLOON SIZE 1.5X15MM WAS INFLATED THREE TIME TO 12 ATMOSPHERES FOR 5 SECONDS. A QUANTUM MAVERICK BALLOON SIZE 3.0X12MM WAS INFLATED FOUR TIMES TO 16 ATMOSPHERES FOR 10 SECONDS. A 3.5X8MM JOHNSON & JOHNSON CYPHER DRUG ELUTING STENT WAS DEPLOYED AT 14 ATMOSPHERES FOR 20 SECONDS AND A GUIDANT MINI VISION 2.25X15MM STENT WAS DEPLOYED AT 15 ATMOSPHERES FOR 10 SECONDS. MULTIPLE BALLOON INFLATIONS WERE CONTINUED USING THE QUANTUM MAVERICK BALLOON AND THE SPRINTER BALLOON. FURTHER ATTEMPTS TO CROSS THE LESION USING ANOTHER CYPHER DRUG ELUTING STENT WERE UNSUCESSFUL AND THE PROCEDURE WAS ENDED. THERE WERE NO PATIENT COMPLICATIONS. MEDICATIONS RECEIVED INCLUDED ASPIRIN, PLAVIX, NITROGLYCERIN, INTEGRILIN AND HEPARIN. THE PATIENT CONDITION IS OK

    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. 3.5X32MM 8292912

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention