BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1020317 · Received March 26, 2008

    Report

    Report Number
    2134265-2008-00880
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    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 PROD FAMILY WILL BE CONDUCTED. IF THERE IS A ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2008-00881. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE 85% STENOSED LESION BEING TREATED WAS LOCATED IN THE CALCIFIED, SIGNIFICANTLY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). A 2.0 X 12MM MAVERICK BALLOON WAS ADVANCED INTO PLACE INTO THE POSTERIOR DESCENDING AND INFLATED TO 10 ATMS FOR 67 SECONDS WITH ADD'L INFLATIONS TO 12 ATMS FOR 48, 61 AND 63 SECONDS. THE BALLOON WAS WITHDRAWN INTO THE DISTAL RCA AND INFLATED TO 12 ATMS FOR 1 MINUTE AND 12 ATMS FOR 64 SECONDS. FINALLY THE BALLOON WAS WITHDRAWN INTO THE MID LESION AND INFLATED TO 12 ATMS FOR 35 SECONDS AND 12 ATMS FOR 35 SECONDS AND 15 ATMS FOR 49 SECONDS AND 15 ATMS FOR 40 SECONDS. A 3.00X24MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE DISTAL RCA, INFLATED TO 12 ATMS FOR 60 SECONDS. AN EPISODE OF VENTRICULAR FIBRILLATION OCCURRED REQUIRING DIRECT CURRENT CARDIOVERSION DURING PLACEMENT OF THE STENT INTO THE DISTAL RIGHT CORONARY ARTERY. THEN THE PHYSICIAN ATTEMPTED TO PLACE A 3.50X24MM TAXUS EXPRESS2 DRUG ELUTING STENT INTO THE MID RCA, BUT WAS UNABLE TO CROSS THE LESION. DURING REMOVAL OF THE UNDEPLOYED STENT, DISLODGEMENT OCCURRED. A 2.0X12MM MAVERICK BALLOON WAS ADVANCED THROUGH THE STENT AND INFLATED. THE STENT WAS PULLED BACK INTO THE RIGHT FEMORAL ARTERY, HOWEVER AGAIN DISLODGED WHEN ATTEMPTING TO PULL IT THROUGH THE ARTERIAL WALL. THE UNDEPLOYED STENT, AT THIS POINT, WAS IN THE FEMORAL PROFUNDA AT A BIFURCATION. ACCESS WAS OBTAINED ON THE CONTRALATERAL SIDE AND THE STENT WAS RETRIEVED FROM THE RIGHT FEMORAL SYS WITH A 7MM SNARE. MEDICATIONS GIVEN: ASPIRIN, PLAVIX, AND ANGIOMAX. THE PHYSICIAN CHOSE TO STOP THE CASE AND PROCEED AT A LATER DATE. TWO DAYS POST THE INITIAL PROCEDURE THE PT HAD INCREASING ANGINA. ANGIOGRAPHY IDENTIFIED 20-75% RESIDUAL STENOSIS IN THE MID RCA. ROTATIONAL ARTERECTOMY WAS PERFORMED. THE PHYSICIAN EXPERIENCED DIFFICULTY PASSING THE IVUS CATHETER, WIRES, AND TWO TAXUS EXPRESS2 DRUG ELUTING STENTS (3.50X28MM AND 3.50X12MM). INFLATIONS WERE MADE WITH A 3.75X15MM QUANTUM BALLOON, A 3.75X15MM MAVERICK BALLOON, AND A 4.0X15MM MAVERICK BALLOON. AN ATTEMPT TO PLACE A 4.0X18 NON-BSC STENT WAS ALSO UNSUCCESSFUL. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH A 4.0X12 NON BSC STENT. PT STATUS REPORTED AS "STABLE."

    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 3.50X24 MM 0009758778

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ART GUIDE CATHETER| WHISPER GUIDEWIRE| IVUS| CROSS OVER SHEATH| BMW GUIDEWIRE| VISION STENT| VODA 1 GUIDE CATHETER| GRAND SLAM GUIDEWIRE| VOLCANO