BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY?

    MDR report key: 3892220 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03611
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 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 IS A COMBINATION PRODUCT. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    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 MAJORITY OF THE STENT WERE DEFORMED, BUNCHED, OVERLAPPING AND LIFTED UPWARDS FROM THE STENT PROFILE. THE PROXIMAL CRIMPED STENT WAS NOT DAMAGED AND WAS FOUND TO HAVE AN OUTSIDE DIAMETER (OD) WHICH WAS WITHIN SPECIFICATION. IT WAS NOTED THAT THE ENTIRE STENT MOVED DISTALLY 7.7MM ON THE BALLOON. A REVIEW OF THE ASSOCIATED BATCH RECORDS; THE MAXIMUM CRIMPED STENT PROFILE MEASURED WAS WITHIN SPECIFICATION. THE PRODUCT STENT PROTECTOR WAS NOT RETURNED FOR ANALYSIS WITH THE DEVICE, HOWEVER THE SPECIFIED INSIDE DIAMETER OF THE STENT PROTECTOR (ID) WAS WITHIN SPECIFICATION. THE BALLOONS PROXIMAL CONE PROFILE WAS REVIEWED AND NO ISSUES WERE NOTED. THE PROXIMAL BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. IT WAS NOT POSSIBLE TO EXAMINE THE DISTAL CONE OF THE BALLOON AS THE STENT HAD MOVED OUT OVER THE DISTAL PORTION. CRIMP MARKINGS WERE EVIDENT ON THE WALL OF THE BALLOON THAT WAS EXPOSED DUE TO THE MOVEMENT OF THE STENT, AS WOULD BE EXPECTED. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT PROFILE. 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 CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 38X2.50MM SYNERGY STENT WAS SELECTED TO TREAT THE LESION. PRIOR TO INSERTION OF THE DEVICE TO THE UNSPECIFIED INTRODUCER SHEATH, THE PHYSICIAN DID HIS ROUTINE CHECK ON THE DEVICE AND DISCOVERED THAT THE STENT STRUT OF THE DEVICE WAS ALREADY DAMAGED. ANOTHER SYNERGY 2.5 X 38 STENT WAS OPENED AND IT WAS FINE. 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. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 38X2.50MM SYNERGY¿ STENT WAS SELECTED TO TREAT THE LESION. PRIOR TO INSERTION OF THE DEVICE TO THE UNSPECIFIED INTRODUCER SHEATH, THE PHYSICIAN DID HIS ROUTINE CHECK ON THE DEVICE AND DISCOVERED THAT THE STENT STRUT OF THE DEVICE WAS ALREADY DAMAGED. ANOTHER SYNERGY 2.5 X 38 STENT WAS OPENED AND IT WAS FINE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368931 SYNERGY? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493919838250 16656126

    Patients

    Seq Age Sex Outcome Treatment
    1