BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY?

    MDR report key: 3842493 · Received June 2, 2014

    Report

    Report Number
    2134265-2014-02950
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL EXAMINATION OF THE STENT FOUND THAT THE CRIMPED STENT ON THE DEVICE WAS DAMAGED AND MOVED ON THE BALLOON. STENT STRUTS THROUGHOUT THE ENTIRE STENT WERE DEFORMED, BUNCHED, OVERLAPPING AND LIFTED UPWARDS FROM THE STENT PROFILE. IT WAS NOTED THAT THE ENTIRE STENT MOVED PROXIMALLY ON THE BALLOON. THE BALLOONS DISTAL CONE PROFILE WAS REVIEWED AND NO ISSUES WERE NOTED. THE DISTAL BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. IT WAS NOT POSSIBLE TO EXAMINE THE PROXIMAL CONE OF THE BALLOON AS THE STENT HAD MOVED OUT OVER THE PROXIMAL PORTION. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. 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 STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 95% STENOSED, 14X2.5MM, ECCENTRIC AND DE NOVO TARGET LESION CONTAINING A SIGNIFICANT <=45 DEGREE LESION BEND WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING A NON-BSC GUIDE WIRE, PREDILATION WAS PERFORMED USING A 2.25X9 MAVERICK BALLOON CATHETER AND A 3.0X10 FLEXTOME CUTTING BALLOON WAS USED RESULTING TO 85% RESIDUAL STENOSIS AND A 6F NON-BSC GUIDE CATHETER WAS ADVANCED. A 16X2.25MM SYNERGY DRUG-ELUTING STENT WAS THEN SELECTED TO TREAT THE TARGET LESION. HOWEVER, THE PHYSICIAN FELT RESISTANCE WHEN DELIVERING THE STENT THROUGH THE GUIDE CATHETER. THE DEVICE WAS REMOVED AND WAS NOTICED THAT THE DISTAL TIP OF THE STENT WAS FRAYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 95% STENOSED, 14X2.5MM, ECCENTRIC AND DE NOVO TARGET LESION CONTAINING A SIGNIFICANT <=45 DEGREE LESION BEND WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING A NON-BSC GUIDE WIRE, PREDILATION WAS PERFORMED USING A 2.25X9 MAVERICK BALLOON CATHETER AND A 3.0X10 FLEXTOME CUTTING BALLOON WAS USED RESULTING TO 85% RESIDUAL STENOSIS AND A 6F NON-BSC GUIDE CATHETER WAS ADVANCED. A 16X2.25MM SYNERGY¿ DRUG-ELUTING STENT WAS THEN SELECTED TO TREAT THE TARGET LESION. HOWEVER, THE PHYSICIAN FELT RESISTANCE WHEN DELIVERING THE STENT THROUGH THE GUIDE CATHETER. THE DEVICE WAS REMOVED AND WAS NOTICED THAT THE DISTAL TIP OF THE STENT WAS FRAYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321039 SYNERGY? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493919816220 0016404514

    Patients

    Seq Age Sex Outcome Treatment
    1 FLEXTOME 3.0X10| 6F EBU 3.5| RINATO| MAVERICK 2.25X9,