BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 598465 · Received April 29, 2005

    Report

    Report Number
    6000093-2005-00407
    Event Type
    Injury
    Date Received
    April 29, 2005
    Date of Event
    March 21, 2005
    Report Date
    March 30, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS 6000093-2005-00522, 00508. 8 DAYS POST A CORONARY STENTING TREATMENT PROCEDURE, A SECOND EPISODE OF THROMBOSIS OCCURRED. THE PATIENT PRESENTED TO THE CATH LAB FOR AN ELECTIVE PROCEDURE IN 2005. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE MID LAD LESION WAS PREDILATED WITH A 2.5X20MM MAVERICK BALLOON. THE PHYSICIAN THEN POSITIONED THE TAXUS EXPRESS2 2.5X24MM DRUG ELUTING STENT. THE SHEATH WAS REMOVED AND AN ANGIOSEAL WAS DEPLOYED WITH MANUAL PRESSURE APPLIED TO THE SITE UNTIL HEMOSTASIS WAS OBTAINED. THE PATIENT RECEIVED HEPARIN, VERSED, MORPHINE AND INTRA CORONARY NITROGLYCERINE (NTG) DURING THE PROCEDURE. THE PATIENT ALSO RECEIVED A REOPRO BOLUS, A LOADING DOSE OF PLAVIX AND A REOPRO DRIP WAS STARTED. THE NEXT DAY, THE PATIENT WAS BROUGHT BACK TO THE CATH LAB WITH COMPLAINTS OF CHEST PAIN RANGING FROM 6 1/2 TO 9 1/2 ON A 0-10 SCALE. THE PATIENT WAS TREATED WITH VALIUM. ACCESS WAS AGAIN OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE THROMBOSIS IN THE PROXIMAL LAD WAS FIRST TREATED WITH A 2.5X20MM MAVERICK BALLOON. THE PHYSICIAN THEN IMPLANTED AN 2.75X24MM EXPRESS2 BARE METAL STENT. AN ANGIOSEAL WAS USED AGAIN AT THE PUNCTURE SITE. EIGHT DAYS LATER, TEH PATIENT DEVELOPED WORSENING CONGESTIVE HEART FAILURE (CHF) AND WENT TO THE ER. ONCE THERE, THE PATIENT WAS FOUND TO HAVE PULMONARY EDEMA WITH EKG CHANGES AND "POSSIBLE EXTENSION OF RECENT STUTTERING ANTERIOR WALL MYOCARDIAL INFARCTION" (MI). THE PATIENT WAS INTUBATED. THE PATIENT HAD NOT BEGAN COMPLIANT WITH PLAVIX. IN THE CATH LAB, VENOUS AND ARTERIAL ACCESS WAS OBTAINED THROUGH RIGHT FEMORAL. ANGIOGRAM REVEALED "STUMP OCCLUDED LAD AT THE SITE OF THE FORMER STENT PLACEMENT." THE PROXIMAL LAD WAS TREATED WITH A 2.5X30MM MAVERICK BALLOON INFLATED TO 10 ATM'S FOR 60 SECONDS. A TAXUS EXPRESS2 2.75X32MM DRUG ELUTING STENT WAS THEN PLACED AND THE BALLOON WAS INFLATED TWICE TO 9 ATM'S FOR 30 SECONDS AND 40 SECONDS. A NTG DRIP WAS DC'D. A NATRECOR BOLUS WAS GIVEN AND A DRIP WAS STARTED. ABOUT 30 MINUTES LATER, PATIENT'S BLOOD PRESSURE HAD DROPPED TO 50/30 AND THE NATRECOR DRIP WAS STOPPED. PATIENT'S BP RETURNED TO 127/71. THE NTG DRIP WAS RESTARTED AND A SWAN GANZ WAS PLACED VIA THE RIGHT FEMORAL VEIN. THE PATIENT RECEIVED VERSED ADN NORCURON FOR SEDATION AND PARALYSIS AFTER BITING THE ENDOTRACHEAL TUBE. PROCEDURE WAS COMPLETE AND PATIENT WAS TRANSFERRED TO THE NURSING FLOOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NO ADDITIONAL COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED TO BE SATISFACTORY.

    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% 2.50 X 24MM 7166334

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention