BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 6601011 · Received May 31, 2017

    Report

    Report Number
    2134265-2017-05337
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    May 9, 2017
    Report Date
    May 11, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    UDI-DI
    08714729840107
    PMA / PMN Number
    P150003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND NO ISSUES. THERE WAS NO SIGN OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET EQUIDISTANT BETWEEN THE PROXIMAL AND DISTAL MARKERBANDS. THE CRIMPED STENT OUTER DIAMETER WAS MEASURED AND IS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. 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 MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE HYPOTUBE KINKS ALONG THE FULL LENGTH OF THE CATHETER. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT POLYMER EXTRUSION FOUND A BREAK AT THE PORT WELD SITE AND MULTIPLE INNER/OUTER POLYMER EXTRUSION KINKS ALONG THE FULL LENGTH OF THE SHAFT POLYMER EXTRUSION. 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 CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75X16MM SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING PREPARATION, AS THE PHYSICIAN WAS PULLING THE STENT PROTECTOR OFF TO THE DISTAL END, THE SHAFT BROKE INTO TWO. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75X16MM SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING PREPARATION, AS THE PHYSICIAN WAS PULLING THE STENT PROTECTOR OFF TO THE DISTAL END, THE SHAFT BROKE INTO TWO. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382007 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC - GALWAY H7493926016270 19719505 08714729840107

    Patients

    Seq Age Sex Outcome Treatment
    1