BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 7744875 · Received August 2, 2018

    Report

    Report Number
    2134265-2018-06976
    Event Type
    Malfunction
    Date Received
    August 2, 2018
    Date of Event
    July 13, 2018
    Report Date
    July 13, 2018
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P150003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: SYNERGY II US MR 3.50 X 38MM STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION OF THE CRIMPED STENT IDENTIFIED STENT DAMAGE. DAMAGE WAS NOTED TO THE ENTIRE STENT; THE DISTAL END OF THE STENT WAS DAMAGED AND PULLED OVER THE TIP. THE PROXIMAL END OF THE STENT IS DAMAGED AND BUNCHED OVER THE DISTAL BALLOON CONE. THE STENT HAD MOVED DISTALLY ALONG THE BALLOON. THE BALLOON CONES WERE REVIEWED AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE HYPOTUBE KINKS ALONG THE FULL LENGTH OF THE CATHETER AND A HYPOTUBE BREAK 840MM DISTAL FROM THE DISTAL END OF THE STRAIN RELIEF. A VISUAL AND TACTILE EXAMINATION OF SHAFT POLYMER EXTRUSION REVEALED A TEAR AT THE WIRE EXCHANGE PORT, STRETCHING ALONG THE PORT BOND AND MULTIPLE TEARS AND SCRATCHING ALONG THE SHAFT POLYMER EXTRUSION. A VISUAL AND MICROSCOPIC EXAMINATION FOUND DAMAGE TO THE TIP. 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 INVESTIGATION CONCLUSION IS OPERATIONAL CONTEXT AS THE PRODUCT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. (B)(4).

    Description of Event or Problem · 0

    SAME CASE AS MDR ID: 2134265-2018-06975. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED INSIDE THE SHEATH AND A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A PERIPHERAL LIMB. A 3.50 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE SHAFT BROKE AND HEMOSTATS WERE USED TO PULL THE BROKEN PART FROM THE SHEATH. A NEW 3.50 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED WITH THE SUPPORT OF GUIDEZILLA GUIDE EXTENSION CATHETER; HOWEVER, THE SHAFT BROKE AND UPON REMOVAL AND THE STENT DISLODGED IN THE SHEATH. THE DEVICE WAS REMOVED IN ITS ENTIRETY. ANGIOPLASTY WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2018-06975. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED INSIDE THE SHEATH AND A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A PERIPHERAL LIMB. A 3.50 X 38 MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE SHAFT BROKE AND HEMOSTATS WERE USED TO PULL THE BROKEN PART FROM THE SHEATH. A NEW 3.50 X 38 MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED WITH THE SUPPORT OF GUIDEZILLA GUIDE EXTENSION CATHETER; HOWEVER, THE SHAFT BROKE AND UPON REMOVAL AND THE STENT DISLODGED IN THE SHEATH. THE DEVICE WAS REMOVED IN ITS ENTIRETY. ANGIOPLASTY WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585562 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC - GALWAY H7493926038350 0021919657

    Patients

    Seq Age Sex Outcome Treatment
    1