BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY¿

    MDR report key: 6127020 · Received November 24, 2016

    Report

    Report Number
    2134265-2016-10725
    Event Type
    Injury
    Date Received
    November 24, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 2, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. STENT HAD DETACHED FROM THE BALLOON AND WAS NOT RETURNED FOR ANALYSIS. STENT DETACHMENT MAY HAVE OCCURRED DURING WITHDRAWAL OF THE DEVICE DUE TO THE COMPLEX ANATOMY OF THE PATIENT. THE BALLOON CONES AND BALLOON MAIN BODY WERE REVIEWED AND ANALYSIS SUGGESTS THAT THE BALLOON MAY HAVE BEEN SUBJECTED TO POSITIVE PRESSURE AS THE BALLOON WINGS WERE OPENED OUT FROM THEIR FOLDED POSITIONS AND SOLIDIFIED MEDIA WAS PRESENT INSIDE THE BALLOON CHAMBER. CRIMP MARKINGS ON THE BALLOON WALL ARE NOT AS PROMINENT DUE TO THE BALLOON PREVIOUSLY RECEIVING POSITIVE PRESSURE OR MANIPULATION. AN INFLATED BALLOON TENDS TO REDUCE THE PILLOWING EFFECT CAUSED DURING THE STENT CRIMPING PROCESS. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION OF THE MID-SHAFT SECTION FOUND A MIDSHAFT KINK AT 97MM PROXIMAL FROM THE PORT SKIVE. THIS TYPE OF DAMAGE IS LIKELY TO HAVE BEEN CAUSED BY EXCESSIVE TENSILE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE OUTER EXTRUSION, INNER LUMEN AND BI-COMPONENT BOND SHOWED NO SIGNS OF DAMAGE OR STRAIN. 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 OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE AND DISLODGEMENT OCCURRED. THE PATIENT WAS PRESENTED WITH ACUTE MYOCARDIAL INFARCTION (AMI). THE 100% STENOSED, 25MM X4.0MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). FOLLOWING PREDILATION USING A 2.0MM NON-BSC BALLOON CATHETER FOR 15 SECONDS, AN IMAGING CATHETER WAS INSERTED BUT FAILED TO CROSS THE LESION AND ADDITIONAL DILATION WAS PERFORMED WITH MORE PRESSURE. A 4.00 X 28 SYNERGY¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PHYSICIAN NOTED THAT THE STENT STRUTS WAS LIFTED. DURING REMOVAL OF THE DEVICE BACK INTO THE GUIDE CATHETER, IT WAS NOTED THAT THE STENT DISLODGED IN FRONT OF THE LESION AND WAS RETRIEVED USING A MICRO SNARE. ADDITIONAL DILATATION WAS PERFORMED USING A 2.5 NC BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED WITH DEPLOYMENT OF A NON-BSC STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND NO PROBLEM WITH THE PATIENT'S STATUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE AND DISLODGEMENT OCCURRED. THE PATIENT WAS PRESENTED WITH ACUTE MYOCARDIAL INFARCTION (AMI). THE 100% STENOSED, 25MM X4.0MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). FOLLOWING PREDILATION USING A 2.0MM NON-BSC BALLOON CATHETER FOR 15 SECONDS, AN IMAGING CATHETER WAS INSERTED BUT FAILED TO CROSS THE LESION AND ADDITIONAL DILATION WAS PERFORMED WITH MORE PRESSURE. A 4.00 X 28 SYNERGY¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PHYSICIAN NOTED THAT THE STENT STRUTS WAS LIFTED. DURING REMOVAL OF THE DEVICE BACK INTO THE GUIDE CATHETER, IT WAS NOTED THAT THE STENT DISLODGED IN FRONT OF THE LESION AND WAS RETRIEVED USING A MICRO SNARE. ADDITIONAL DILATATION WAS PERFORMED USING A 2.5 NC BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED WITH DEPLOYMENT OF A NON-BSC STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND NO PROBLEM WITH THE PATIENT'S STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777567 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926228400 18268033

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HIRYU BALLOON CATHETER