BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 521936 · Received April 23, 2004

    Report

    Report Number
    6000089-2004-00326
    Event Type
    Injury
    Date Received
    April 23, 2004
    Date of Event
    March 15, 2004
    Report Date
    March 24, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004, THE PT RETURNED COMPLAINING OF CHEST PAIN. ANGIOGRAPHY REVEALED THE PROXIMAL END OF THE RECENTLY PLACED TAXUS STENT HAD THROMBOSED, OCCLUDING THE LAD ARTERY. THE PHYSICIAN USED A PT GRAPHICS WIRE TO PASS THROUGH THE THROMBUS AND INSERTED A 2.5 MM X 20 MM NC RANGER BALLOON. AFTER BALLOON INFLATION THERE WAS REESTABLISHED FLOW INTO THE LAD, BUT THE MAJORITY OF THE STENTED SEGMENT HAD PERSISTENT THROMBUS WITH DIFFUSE IRREGULARITY. THE PHYSICIAN THEN BALLOON DILATED WITH A MAVERICK 3.0 MM X 30 MM BALLOON THE PREVIOUS TAXUS STENT AND DISTAL TO THE STENT. THE PHYSICIAN THEN DEPLOYED A TAXUS 3.5 MM X 12 MM STENT OVER THE TAKEOFF OF THE FIRST DIAGONAL EXTENDING INTO THE PREVIOUS STENT. THIS WAS POST DILATED AS WELL AS THE INITIAL TAXUS STENT WITH A 3.25 X 15 MAVERICK BALLOON. THE ANGIOGRAPHIC RESULT WAS GOOD WITH NO RESIDUAL STENOSIS IN THE PROXIMAL LAD. IV HEPARIN AND INTEGRILIN WERE ADMINISTERED. THE STATUS OF THE PT IS LISTED AS GOOD.

    Description of Event or Problem · 1

    IN 2004, THE PT RETURNED COMPLAINING OF CHEST PAIN. ANGIOGRAPHY REVEALED THE PROXIMAL END OF THE RECENTLY PLACED TAXUS STENT HAD THROMBOSED, OCCLUDING THE LAD ARTERY. THE PHYSICIAN USED A PT GRAPHICS WIRE TO PASS THROUGH THE THROMBUS AND INSERTED A 2.5 MM X 20 MM NC RANGER BALLOON. AFTER BALLOON INFLATION THERE WAS REESTABLISHED FLOW INTO THE LAD, BUT THE MAJORITY OF THE STENTED SEGMENT HAD PERSISTENT THROMBUS WITH DIFFUSE IRREGULARITY. THE PHYSICIAN THEN BALLOON DILATED WITH A MAVERICK 3.0 MM X 30 MM BALLOON THE PREVIOUS TAXUS STENT AND DISTAL TO THE STENT. THE PHYSICIAN THEN DEPLOYED A TAXUS 3.5 MM X 12 MM STENT OVER THE TAKEOFF OF THE FIRST DIAGONAL EXTENDING INTO THE PREVIOUS STENT. THIS WAS POST DILATED AS WELL AS THE INITIAL TAXUS STENT WITH A 3.25 X 15 MAVERICK BALLOON. THE ANGIOGRAPHIC RESULT WAS GOOD WITH NO RESIDUAL STENOSIS IN THE PROXIMAL LAD. IV HEPARIN AND INTEGRILLIN WERE ADMINISTERED. THE STATUS OF THE PT IS LISTED AS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 DAYS AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PT DEVELOPED A SUBACUTE THROMBOSIS. IN 2004, THE PHYSICIAN HAD IMPLANTED TAXUS EXPRESS2 2.75 X 32MM AND TAXUS EXPRESS2 2.75 X 12MM DRUG ELUTING STENTS IN THE LAD. THE PT RETURNED TWO DAYS LATER WITH A SUBACUTE THROMBOSIS. THE PT RETURNED FOR INTERVENTION WHICH CONSISTED OF REVASCULARIZING THE LAD WITH AN NC MONORAIL BALLOON CATHETER. THE DIAGONAL BRANCH WAS TREATED WITH A CUTTING BALLOON. IT WAS REPORTED THAT THE PT HAD A "CLOTTING DISORDER" AND HAD PREVIOUSLY BEEN ON COUMADIN, BUT HAD DISCONTINUED IT. THE PT REPORTED THIS INFO TO THE STAFF UPON THEIR RETURN FOR TREATMENT OF THE SAT. NO OTHER INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE INITIAL PROCEDURE IN 2004, THE PHYSICIAN USED A VODA L4.0 GUIDE CATHETER AND A 0.014 CHOICE FLOPPY GUIDE WIRE TO CROSS THE SITE OF THE OCCLUSION AND THE SEVERE STENOSIS IN THE MID SEGMENT OF THE LAD. A 2.0 MM X 20 MM NC RANGER BALLOON WAS INFLATED AND RESTORED FLOW TO THE DISTAL LAD. HOWEVER, THERE WAS A SIGNIFICANT DISSECTION AFTER THE INITIAL BALLOON INFLATION. THE PHYSICIAN THEN PASSED A TAXUS EXPRESS2 8.8% 2.75 MM X 32 MM PROXIMAL TO THE TAKEOFF OF THE FIRST DIAGONAL BRANCH. IT WAS SUCCESSFULLY DEPLOYED AND ESTABLISHED FLOW TO THE DISTAL VESSEL. THE ANGIOGRAPHIC RESULT WAS GOOD. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED A TAXUS EXPRESS2 2.75 MM X 12 MM STENT, OVERLAPPING THE FIRST TAXUS STENT IN THE MID LAD AND COVERING A 90% MID VESSEL STENOSIS. AFTER 2 HIGH PRESSURE INFLATIONS TO 16 ATMS, THE FINAL ANGIOGRAPHIC RESULT WAS GOOD. THE PT IS LISTED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 2.75 X 32 MM 6214932

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention