BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 4202430 · Received October 27, 2014

    Report

    Report Number
    2134265-2014-06410
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    May 14, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE CORRECTED FROM (B)(6) 2014 TO (B)(6) 2014. DESCRIBE EVENT OR PROBLEM UPDATED, DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES UPDATED. DEVICE EVALUATED BY MFR.: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. THE BALLOON CONE PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE CRIMPED STENT WAS DETACHED FROM BALLOON AND NOT RETURNED WITH DEVICE FOR ANALYSIS. CRIMP MARKINGS WERE EVIDENT ON THE WALL OF THE BALLOON INDICATING THAT FULL CRIMP CONTACT WAS ACHIEVED BETWEEN THE STENT AND BALLOON. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE HYPOTUBE SHAFT PROFILE. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE PROFILE OF THE SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/ PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH MYOCARDIAL INFARCTION. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 80% STENOSED, 16X2.75MM, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. PRE-DILATION WAS PERFORMED WITH A NON-BSC BALLOON CATHETER. FOLLOWING PRE-DILATION, RESIDUAL STENOSIS WAS 70%. A 16 X 2.75MM TAXUS¿ LIBERTÉ¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. IT WAS NOTED THAT THE DEVICE ENTERED THE BODY TWICE AND THERE WAS RESISTANCE DURING ADVANCING AND REPOSITIONING. THE STENT WAS DEPLOYED AT 12 ATMS FOR 12 SECONDS AND WAS NOTED TO BE FULLY EXPANDED. HOWEVER, THE STENT DISLODGED AND EMBOLIZED TO THE ILIAC ARTERY. NO ATTEMPTS WERE MADE TO RETRIEVE THE STENT. THE PROCEDURE WAS NOT COMPLETED; THE PATIENT WILL BE UNDER OBSERVATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE STENT WAS NOT DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681762 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894016270 16455260

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O POWER LINE 1.5X 20= BALLOON| 6F MACH1 / FL4= GUIDE CATHETER| BMW ¿ MODERATE= GUIDE WIRE