BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1053608 · Received May 23, 2008

    Report

    Report Number
    2134265-2008-01490
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    February 8, 2008
    Report Date
    April 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC ONE-SCIMED PLACE
    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 EVALUAION: THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IN THE PT AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE SHOPFLOOR PAPERWORK FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPECS. AS NO DEVICE WAS RECEIVED FOR ANALYSIS, THE ROOT CAUSE OF THIS COMPLAINT WILL BE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    POST MARKET SURVEILLANCE STUDY. IT WAS REPORTED THAT 128 DAYS AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PT REQUIRED A TARGET VESSEL REINTERVENTION (TVR). THE INDEX PROCEDURE TREATED A 2.5X22MM, 100% STENOSED, MODERATELY CALCIFIED, DE NOVO LESION LOCATED IN THE MID TO DISTAL PORTION OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD). PRE-PROCEDURE TIMI GRADE WAS 0. A TAXUS EXPRESS2 2.5X24MM DRUG ELUTING STENT WAS DEPLOYED AT MAXIMUM 10ATM WITH DIRECT STENTING. THE STENT WAS POST-DILATED BY A 3.0X15MM BALLOON AT MAXIMUM 14ATM. TOTAL TWO BALLOON CATHETERS WERE USED FOR THE POST-DILATION, BUT THE DETAILS WERE UNK. POST-IVUS WAS PERFORMED. THE PHYSICIAN CONFIRMED THAT POST-PROCEDURE STENOSIS WAS 12%, TIMI GRADE WAS 3, AND TARGET LESION DIAMETER WAS 2.85MM (MINIMUM DIAMETER 2.5MM). THE STENT PLACEMENT WAS WELL POSITIONED AND WELL APPOSED. THE PROCEDURE WAS COMPLETED WITH NO PT COMPLICATIONS OR INJURIES. THE PT WAS DISCHARGED FROM THE HOSPITAL 2 DAYS LATER. FOLLOW-UP EVALUATION WAS PERFORMED ONE MONTH LATER. THERE WAS NO PT SYMPTOM. AT 128 DAYS POST INDEX PROCEDURE, 62.5% PROXIMAL EDGE STENT RESTENOSIS WAS CONFIRMED. TARGET VESSEL DIAMETER WAS 3.00MM (MINIMUM DIAMETER 1.13MM, LENGTH 7.6MM) WITH TIMI GRADE 3. THE PT SYMPTOM WAS STABLE ANGINA PECTORIS. AN UNK SIZE TAXUS STENT WAS IMPLANTED IN THE RESTENOSIS LESION ON THE SAME DAY. POST-PROCEDURE STENOSIS WAS 4%. TARGET VESSEL DIAMETER WAS 3.02MM (MINIMUM DIAMETER 2.89MM) WITH TIMI GRADE 3. THE PT WAS IN REMISSION STATUS THE NEXT DAY. FOLLOW-UP EVALUATION WAS PERFORMED ONE MONTH LATER WITH NO PT SYMPTOMS. ACCORDING TO THE PHYSICIAN, THIS EVENT MIGHT BE RELATED TO THE TAXUS STENT AND THE PROCEDURE, BUT NOT RELATED TO THE ANTIPLATELET AGENTS.

    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 ONE-SCIMED PLACE 2.5X24MM 9660501

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R