BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1024348 · Received April 3, 2008

    Report

    Report Number
    2134265-2008-00971
    Event Type
    Injury
    Date Received
    April 3, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INFORMATION 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, STENT OCCLUSION OCCURRED. THE LESION BEING TREATED WAS LOCATED AT A BIFURCATION IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS MID TO DISTAL LEFT ANTERIOR DESCENDING (LAD). THE VESSEL WAS 2.5 MM IN DIAMETER AND THE LESION WAS 20MM IN LENGTH. THE PHYSICIAN PERFORMED PRE-INTRAVASCULAR ULTRASOUND (IVUS) AND NOTICED THE REMAINS OF A PLAQUE RUPTURE AT THE DISTAL SIDE OF THE MID LAD. AN UNKNOWN TYPE GUIDE WIRE WAS INSERTED TO THE LAD 1ST DIAGONAL (LAD D1) IN ADDITION TO AN UNKNOWN TYPE GUIDE WIRE WHICH WAS INSERTED TO THE LAD MAIN ARTERIA CORONARIA. THE PROXIMAL SIDE OF THE TARGET LESION WAS PREDILATED BY A 2.5 X 15MM NON-BSC BALLOON AT 10 ATMS. THEN, THE PHYSICIAN PLACED THE GUIDEWIRE THAT HAD BEEN IN THE LAD D1 AND RE-INSERTED IT TO THE LAD 2ND DIAGONAL (LAD D2). THE DISTAL SIDE OF THE TARGET LESION WAS PRE-DILATED WITH THE 2.5 X 15MM NON-BSC BALLOON AT 10 ATMS. THE PHYSICIAN THEN ADVANCED AND DEPLOYED A 2.50 X 24MM TAXUS EXPRESS2 DRUG ELUTING STENT AT THE TARGET LESION 9 ATMS. CORONARY ANGIOGRAPHY WAS PERFORMED, AND THE PHYSICIAN NOTICED A SLIGHT INDENTATION AT THE MIDDLE OF THE STENT. THE DISTAL SIDE OF THE STENT WAS DILATED BY THE NON-BSC BALLOON AT 20 ATMS, AND THE MIDDLE OF THE STENT WAS DILATED BY THE NON-BSC BALLOON AT 18 ATMS. THE PROXIMAL SIDE OF THE STENT WAS DILATED BY THE NON-BSC BALLOON AT 16 ATMS. CORONARY ANGIOGRAPHY WAS PERFORMED AGAIN, AND THE PHYSICIAN CONFIRMED THAT THERE WAS NO INDENTATION OF THE STENT. POST-IVUS WAS PERFORMED, AND A SLIGHT INCOMPLETE APPOSITION WAS CONFIRMED AT THE DISTAL SIDE OF THE STENT (WHERE THE PLAQUE RUPTURE LESION WAS NOTED). HOWEVER, IN THE PHYSICIAN'S OPINION IT WAS DIFFICULT TO GET A MORE COMPLETE APPOSITION DUE TO THE PLAQUE RUPTURE CONDITION. THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER COMPLICATIONS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOUR DAYS LATER. ONE HUNDRED AND TWENTY NINE DAYS POST THE ORIGINAL IMPLANT, THE PATIENT COMPLAINED OF SLIGHT CHEST PAIN, BUT THERE WERE NO ELECTROCARDIOGRAM (ECG) CHANGES, SO THE PHYSICIAN TOOK A WAIT-AND-SEE APPROACH. FIFTY THREE DAYS LATER, THE PATIENT PRESENTED FOR A 6 MONTH FOLLOW UP. AGAIN, THERE WERE NO ECG CHANGES, BUT CORONARY ANGIOGRAPHY SHOWED A TOTAL OCCLUSION AT THE DISTAL SIDE OF THE STENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL. SEVEN DAYS LATER, THE PHYSICIAN USED AN UNKNOWN TYPE GUIDE WIRE TO CROSS THE LESION AND DILATE THE OCCLUSION WITH AN UNKNOWN SIZE QUANTUM MAVERICK BALLOON. BLOOD FLOW WAS IMPROVED AND THE PROCEDURE WAS COMPLETED. ONE DAY LATER THE PATIENT HAD RECOVERED AND WAS IN STABLE CONDITION, WITH PLANS TO DISCHARGE FROM THE HOSPITAL WITHIN DAYS. THE PATIENT'S ANTIPLATELET THERAPY CONSISTS OF PLAVIX, BABYASPIRIN, AND PANALDINE. THE PATIENT HAD DEVELOPED HEPATOPATHY IN REACTION TO TICLOPIDINE, SO THIS PRESCRIPTION WAS DISCONTINUED. THE PATIENT WAS COMPLIANT WITH HER ANTIPLATELET THERAPY.

    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 CORPORATION 2.50X24MM

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention BALLOON: 2.5X15MM NC MERCURY