BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 911375 · Received September 12, 2007

    Report

    Report Number
    6000089-2007-01253
    Event Type
    Injury
    Date Received
    September 12, 2007
    Date of Event
    July 11, 2007
    Report Date
    August 21, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON. PER PROCEDURE NOTES RECEIVED, A 2.0 X 12 MM MAVERICK 2 RX BALLOON WAS INSERTED INTO THE DISTAL CIRCUMFLEX (LCX) ARTERY AND INFLATED TO 9 ATMS FOR 13 SECONDS, 10 ATMS FOR 11 SECONDS (MORE PROXIMAL THAN PREVIOUS INFLATION) AND ONCE IN THE PROXIMAL LCX TO 12 ATMS FOR 13 SECONDS. A 2.5X 20 MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS INSERTED AND ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. THE STENT SLID PARTLY OFF THE BALLOON UNDEPLOYED. THE PHYSICIAN CUT THE END OFF THE BALLOON CATHETER AND REMOVED THE 6FR GUIDE CATHETER. AN UNK TYPE STANDARD WIRE WAS INSERTED, THE 6FR SHEATH WAS REMOVED AND AN UNK TYPE 8FR X11CM INTRODUCER WAS INSERTED INTO THE RIGHT FEMORAL ARTERY OVER THE BALLOON CATHETER. THEN THE LEFT FEMORAL ARTERY WAS ACCESSED AND A 2.5X16MM TAXUS EXPRESS2 DES WAS INSERTED AND DEPLOYED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AT 11 ATMS FOR 30 SECONDS. A 2.5X12MM TAXUS EXPRESS2 WAS INSERTED AND DEPLOYED IN THE DISTAL RCA. ALL INTERVENTIONAL EQUIPMENT THROUGH THE LEFT SHEATH WAS REMOVED. THEN ANOTHER INTRODUCER WAS INSERTED INTO THE RIGHT FEMORAL ARTERY AND A NON-BSC SNARE WAS INSERTED TO RETRIEVE THE 2.5X20MM TAXUS EXPRESS2 DES. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "OK." THE PT WAS GIVEN VERSED, NITROGLYCERIN, ANGIOMAX, INTETRILIN, OMNIPAQUE, AND FENTANYL DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.5X20MM 9266569

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention Z2 GUIDE CATHETER| EV3 AMPLATZ GOOSE NECK SNARE