BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1080941 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02057
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    November 24, 2006
    Report Date
    June 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT THROMBOSIS OCCURRED. THE PT PRESENTED WITH STUNNING CHEST PAIN AND WAS GIVEN INTRAVENOUS NITROGLYCERIN. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH A 2.5X12MM NON-BSC BALLOON, INFLATED TWICE TO 14ATM WITH SIGNIFICANT RECOIL AND NOT ADEQUATE EXPANSION. IC NITROGLYCERIN AND IC ADENOSINE WERE GIVEN SHOWING IMPROVEMENT IN THE DISTAL BLOOD FLOW. A 3.50X16MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED AT 12 ATM. THE STENT WAS POST DILATED WITH AN UNK 4.0X9MM BALLOON, INFLATED THREE TIMES TO 14 ATM. THE STENT EXHIBITED ADEQUATE EXPANSION AND OPPOSITION TO THE WALL. THE PT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE TIME, AND HIS PAIN SYNDROME IMPROVED SIGNIFICANTLY. TIMI III FLOW WAS ACHIEVED DISTALLY, HOWEVER, THE SMALL DIAGONAL BRANCH THAT ORIGINATED JUST PAST THE LESION SITE HAS SIGNIFICANT COMPROMISE FLOW TRANSIENTLY THAT IMPROVED TOWARDS THE END OF THE PROCEDURE WITH IC VASODILATORS. FOUR MONTHS LATER, THE PT PRESENTED TO THE HOSP WITH A THREE DAY HISTORY OF SHORTNESS OF BREATH, COUGH, WHEEZING, AND ATYPICAL LEFT SIDE CHEST PAIN. THE CLINICAL IMPRESSION WAS ACUTE BRONCHITIS. TWO YRS AND FOUR MONTHS POST THE INITIAL STENT PLACEMENT, THE PT PRESENTED WITH STUTTERING CHEST PAIN THAT OCCUR WITH ANY ACTIVITY, RESPONSIVE TO SUBLINGUAL NITROGLYCERINE. THE PT HAS NOT BEEN COMPLIANT WITH HIS MEDICATIONS AND ESSENTIALLY HAD STOPPED ALL OF HIS PILLS OVER THE LAST YR. ANGIOGRAPHY IDENTIFIED THROMBUS IN THE PREVIOUSLY PLACED STENT. ANGIOJET THROMBECTOMY WAS PERFORMED ACROSS THE LAD, UTILIZING THROMBECTOMY CATHETER THREE TIMES. THE PT DEVELOPED VENTRICULAR FIBRILLATION REQUIRING ELECTROCARDIOVERSION. THEN THE PT DEVELOPED ATRIAL FIBRILLATION FOLLOWING CONVERSION, WHICH WAS TREATED WITH ELECTROCARDIOVERSION AND INTRAVENOUS BOLUS OF AMIODARONE. THE PHYSICIAN PLACED AN UNK NON-DRUG ELUTING STENT ACROSS THE ECTATIC LONG DISEASED SEGMENT, WHICH APPEARED ANGIOGRAPHICALLY TO HAVE SIGNIFICANT IRREGULARITIES. TIMI III FLOW WAS MAINTAINED THROUGHOUT THE PROCEDURE TIME IN THE LEFT ANTERIOR DESCENDING. A 3.5X24MM NON-BSC STENT WAS DEPLOYED ACROSS THE ENTIRE DISEASED SEGMENT, INFLATED ONCE TO 15 ATM. THE STENT LOCATED IN THE PROXIMAL PORTION CONTAINING THE ECTATIC SEGMENT WAS POST DILATED WITH AN UNK 4.0X16MM NON-COMPLIANT BALLOON, INFLATED TO 22 ATM, ACHIEVING 4.4MM LUMEN. MEDICATION: IC NITROGLYCERIN. IMAGES AROUND THE GUIDEWIRE SHOWED GOOD POSITION OF THE STENT AND TIMI III FLOW. NO EVIDENCE OF DISSECTION OF PERFORATION. THE PT WAS HEMODYNAMICALLY STABLE AND TRANSFERRED TO HIS ROOM IN A STABLE CONDITION. ASPIRIN AND PLAVIX WERE PRESCRIBED. THREE MONTHS POST THE REINTERVENTION, THE PT PRESENTED WITH RAPID PALPITATIONS AND "FEELING LIKE PASSING OUT". THE PT'S EJECTION FRACTION WAS 40%, SHOWING PROGRESSIVE IMPROVEMENT IN HIS ECHOCARDIOGRAM ASSESSMENT, MAKING RECURRING CORONARY ARTERY DISEASE LESS LIKELY.

    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 3.50X16 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other VOYAGER BALLOON| DRIVER STENT