BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY¿

    MDR report key: 6549152 · Received May 5, 2017

    Report

    Report Number
    2134265-2017-04445
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Date of Event
    April 18, 2017
    Report Date
    April 18, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THAT PROXIMAL STENT ROWS 1 AND 10 WERE DAMAGED AND THE STENT STRUTS WERE LIFTED AND PULLED DISTALLY. THE MAXIMUM CRIMPED STENT PROFILE MEASUREMENT AT THE TIME OF MANUFACTURE WAS WITHIN SPECIFICATION. THE TIP WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED. 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 AND SHAFT POLYMER EXTRUSION FOUND NO ISSUES. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. DEVICE ANALYSIS DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT AS STENT MOVEMENT WAS NOT EVIDENT DURING ANALYSIS. IT WAS REPORTED THAT THE LOT NUMBER INDICATED ON THE BOX #(B)(4) WAS DIFFERENT TO THE LOT NUMBER INDICATED ON THE HUB #(B)(4). A BOTTOM UP ANALYSIS OF THE FINISHED GOODS BATCH (FGB) #(B)(4) WAS PERFORMED AND NO ANOMALIES WERE NOTED. THE FGB BATCH #(B)(4) INDICATED ON THE BOX IS THE FINISHED GOODS BATCH NUMBER (FGB) AFTER THE STENT HAS BEEN CRIMPED ONTO THE SDS WHEREAS THE CATHETER BATCH #(B)(4) PRESENT ON THE CATHETER IS THE CATHETER BATCH NUMBER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT MOVED ON BALLOON AND DEVICE MARKING ISSUE OCCURRED. A 2.25 X 38 SYNERGY¿ DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, UPON REMOVAL OF THE PROTECTION SHEATH, THE STENT MOVED ON THE BALLOON. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. IT WAS ALSO NOTED THAT THE LOT NUMBER ON THE BOX WAS DIFFERENT TO THE LOT NUMBER OF THE HUB OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT MOVED ON BALLOON AND DEVICE MARKING ISSUE OCCURRED. A 2.25 X 38 SYNERGY¿ DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, UPON REMOVAL OF THE PROTECTION SHEATH, THE STENT MOVED ON THE BALLOON. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. IT WAS ALSO NOTED THAT THE LOT NUMBER ON THE BOX WAS DIFFERENT TO THE LOT NUMBER OF THE HUB OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329735 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926238220 19600736

    Patients

    Seq Age Sex Outcome Treatment
    1