BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3983842 · Received August 6, 2014

    Report

    Report Number
    2134265-2014-04944
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND THE DISTAL END OF THE CRIMPED STENT WAS DAMAGED AND LIFTED UPWARDS FROM THE STENT PROFILE. FROM THE ANALYSIS THE DAMAGED DISTAL END IT APPEARS THE CRIMPED STENT RECEIVED PARTIAL INFLATION FROM THE BALLOON. BASED ON THIS EVIDENCE, IT MAY BE LIKELY THAT THE BALLOON EXPERIENCED A LOSS IN PRESSURE DURING THE START OF THE INFLATION ATTEMPT. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKING ON THE HYPOTUBE SHAFT AND THE SHAFT ITSELF WAS BROKEN IN THE REGION OF A SEVERE KINK. THE HYPOTUBE BROKE 690MM DISTAL FROM THE STRAIN RELIEF. THE HYPOTUBE MAY HAVE BROKE DUE TO THE APPLICATION OF EXCESSIVE FORCE WHICH MAY HAVE INITIALLY KINKED THE DEVICE AND THEN RESULTED IN THE HYPOTUBE BREAKING. IT MAY BE POSSIBLE THAT THE BALLOON EXPERIENCED A LOSS IN PRESSURE WHEN THE HYPOTUBE INITIALLY FRACTURED, HOWEVER THIS CANNOT BE CONFIRMED. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE APPARENT WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS APPEARED TO BE TIGHTLY WRAPPED AND EVENLY FOLDED. DURING THE ANALYSIS, INFLATION WAS NOT POSSIBLE DUE TO THE HYPOTUBE BREAK. THEREFORE IT IS DIFFICULT TO DETERMINE IF THE BALLOON HAD EXPERIENCED A LEAK OR RUPTURE. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MIDSHAFT SECTION FOUND NO ISSUES WITH THEIR PROFILE. THE BI-COMPONENT BOND SHOWED NO SIGNS OF DAMAGE OR STRAIN. 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 24 X 3.00MM TAXUS¿ LIBERTÉ¿ DRUG ELUTING STENT WAS SELECTED FOR USE AND ADVANCED TO TREAT THE TARGET LESION. HOWEVER, AS THE DEVICE REACHED THE LESION, THE PHYSICIAN ATTEMPTED TO DILATE THE BALLOON BUT THE BALLOON WOULD NOT DILATE. THE PHYSICIAN OPTED TO WITHDRAW THE DEVICE BUT THE DEVICE'S SHAFT FRACTURED. HALF OF THE SHAFT WAS REMOVED FROM THE PATIENT AND THE OTHER HALF WAS RETAINED INSIDE THE PATIENT'S BODY. TO RESOLVE THE ISSUE, THE PHYSICIAN USED AN UNSPECIFIED BALLOON CATHETER TO REMOVE THE RETAINED SHAFT OF THE STENT DELIVERY SYSTEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 24 X 3.00MM TAXUS LIBERTE DRUG ELUTING STENT WAS SELECTED FOR USE AND ADVANCED TO TREAT THE TARGET LESION. HOWEVER, AS THE DEVICE REACHED THE LESION, THE PHYSICIAN ATTEMPTED TO DILATE THE BALLOON BUT THE BALLOON WOULD NOT DILATE. THE PHYSICIAN OPTED TO WITHDRAW THE DEVICE BUT THE DEVICE'S SHAFT FRACTURED. HALF OF THE SHAFT WAS REMOVED FROM THE PATIENT AND THE OTHER HALF WAS RETAINED INSIDE THE PATIENT'S BODY. TO RESOLVE THE ISSUE, THE PHYSICIAN USED AN UNSPECIFIED BALLOON CATHETER TO REMOVE THE RETAINED SHAFT OF THE STENT DELIVERY SYSTEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461981 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894024300 16563816

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention