BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 556536 · Received November 23, 2004

    Report

    Report Number
    6000093-2004-01379
    Event Type
    Injury
    Date Received
    November 23, 2004
    Date of Event
    October 27, 2004
    Report Date
    October 29, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME AS MFG NUMBER 6000093-2004-1378. IT WAS REPORTED THAT 4 DAYS FOLLOWING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PT EXPERIENCED A SUB ACUTE THROMBOSIS. THE PT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION AND WAS GIVEN INTEGRILIN. A LESION NOTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS 99% STENOSED. IT WAS LOCATED MID-LAD RIGHT BEFORE THE FIRST DIAGONAL AND ANOTHER LESION WAS FOUND IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WHICH WAS MODERATELY DISEASED. THE PT HAD AN EJECTION FRACTION (EF) OF 35%. THE NEXT DAY THE PT WAS TAKEN TO THE CARDIAC CATHETERIZATION LAB (CCL) AND HAD AN UNK SIZE TAXUS STENT IMPLANTED IN THE LAD. IVUS WAS NOT USED. THERE WAS THROMBUS PRESENT IN THE VESSEL AND THERE WAS NO ANGIOJET AVAILABLE FOR USE. THE FIRST STENT DISLODGED THE THROMBUS. THE PT WAS STARTED ON A PLAVIX AND INTEGRILIN REGIMEN FOLLOWING THE IMPLANT. THE PT PRESENTED WITH SYMPTOMS OF A SUB ACUTE THROMBOSIS INCLUDING SHARP CHEST PAIN TWO DAYS LATER AND WAS RETURNED URGENTLY TO THE CCL. A 3.0 X 20 MAVERICK BALLOON WAS INFLATED TO 10 ATMS. THERE WAS IMMEDIATE FREE FLOW OF BLOOD AND THE STENT WAS NOTED TO BE IN GOOD PLACEMENT. AFTER, A TAXUS EXPRESS2 3.0 X 24 MM STENT WAS PLACED IN THE LAD ALONG WITH A TAXUS EXPRESS2 2.5 X 20 MM STENT PLACED IN THE DIAGONAL USING A KISSING TECHNIQUE. WHEN THE PHYSICIAN TRIED TO REMOVE THE STENTS THE TAXUS EXPRESS2 2.5 X 20 MM STENT WAS STICKING TO BALLOON. THE PHYSICIAN INFLATED THE BALLOON TO 25 ATMS, TWICE, BUT WAS UNABLE TO WITHDRAW IT. THE BALLOON FINALLY RELEASED FROM THE STENT AFTER THE 8FR GUIDE WIRE WAS DEEP-SEATED AND THE PHYSICIAN PULLED ON THE CATHETER. TWENTY FOUR HOURS LATER AN ECHOCARDIOGRAM WAS DONE WHICH SHOWED MID-APICAL KINESIS. THE EF WAS NOW AT 55 %. A 3.5 BALLOON WAS INFLATED IN THE RCA AT 14 ATM. THERE WAS GOOD FLOW FOLLOWING THIS. TWO DAYS AFTERWARD THE PT HAD CHEST PAIN AND ACUTE CHANGES IN THEIR EKG. THE LAD HAD "CLIPPED OUT" AND THE PT EXPERIENCED ANOTHER SUB ACUTE THROMBOSIS IN THE LAD/DIAGONAL AREA. A WIRE CROSSED THE LESION AND THE PT'S PAIN IMMEDIATELY STARTED TO FADE. THE PT WAS TRANSFERRED TO ANOTHER FACILITY WHERE PT HAD A DOUBLE CORONARY BYPASS GRAFT PERFORMED. THE PT'S FINAL OUTCOME IS UNK AS THE PHYSICIAN DID NOT HAVE PRIVILEGES AT THE SECOND FACILITY WHERE THE CABG WAS PERFORMED.

    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 UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R