BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 5441865 · Received February 17, 2016

    Report

    Report Number
    2134265-2016-00652
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    January 19, 2016
    Report Date
    January 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P150003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT SEX, DESCRIBE EVENT OR PROBLEM, AND OTHER RELEVANT HISTORY UPDATED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. THE CRIMPED STENT WAS DETACHED FROM BALLOON AND NOT RETURNED WITH DEVICE FOR ANALYSIS. THE BALLOON CONE PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. CRIMP MARKINGS WERE EVIDENT ON THE ENTIRE LENGTH OF THE BALLOON WALL INDICATING OVERALL CRIMP CONTACT BETWEEN THE COATED STENT AND BALLOON. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE SEVERE KINKS ON THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION FOUND SEVERAL MIDSHAFT KINKS ACROSS THE LENGTH OF THE SHAFT POLYMER EXTRUSION PROFILE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 3.50 X 38 SYNERGY II DRUG-ELUTING STENT WAS PREPARED UTILIZING A DILUTED CONTRAST AND A STOPCOCK. AFTER THE ADVANCEMENT OF A 6F NON-BSC GUIDE EXTENSION CATHETER, THE 3.50 X 38 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. UPON RETRACTING THE DEVICE BACK TO THE GUIDE CATHETER, THE STENT EMBOLIZED AND WAS LEFT INSIDE THE CATHETER. A SECOND GUIDE WIRE WAS ADVANCED AND A 3.0 X 32 SYNERGY STENT WAS SUCCESSFULLY ADVANCED AND IMPLANTED. UPON COMPLETION OF THE PROCEDURE, THE GUIDE CATHETER WAS WITHDRAWN AND THE EMBOLIZED STENT WAS CAPTURED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD AND STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED VIA FACILITY MAUDE REPORT 5060221 THAT THE PATIENT PRESENTED WITH UNSTABLE ANGINA. AFTER REMOVAL OF THE NON-BSC GUIDE CATHETER WITH THE DISLODGED STENT, FLUOROSCOPY WAS PERFORMED AND VERIFIED THAT THERE WERE NO PARTS OR PIECES OF THE DETACHED STENT LEFT IN THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED VIA FACILITY MAUDE REPORT 5060221 THAT THE PATIENT PRESENTED WITH UNSTABLE ANGINA. AFTER REMOVAL OF THE NON-BSC GUIDE CATHETER WITH THE DISLODGED STENT, FLUOROSCOPY WAS PERFORMED AND VERIFIED THAT THERE WERE NO PARTS OR PIECES OF THE DETACHED STENT LEFT IN THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99065 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC - GALWAY H7493926038350 18442350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention