BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY¿

    MDR report key: 6102544 · Received November 15, 2016

    Report

    Report Number
    2134265-2016-10252
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 21, 2016
    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.:SYNERGY, OUS, MR, 3.0X32MM, STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES WITH THE CRIMPED STENT. THERE WERE NO SIGNS 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 STENT OD (OUTER DIAMETER) OF THE UNDAMAGED PROXIMAL SECTION WAS MEASURED WHICH IS WITHIN MAX CRIMPED STENT SPECIFICATION INDICATING THAT THERE WERE NO ISSUES WITH THE CRIMP STENT PROFILE. 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 FOUND MULTIPLE KINKS ALONG THE FULL CATHETER LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUE WITH THE EXTRUSION. THE BI-COMPONENT BOND SHOWED NO SIGNS OF DAMAGE OR STRAIN. A VISUAL AND TACTILE EXAMINATION FOUND NO DAMAGE TO THE TIP. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00X38MM SYNERGY¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, RESISTANCE WAS ENCOUNTERED IN THE PROXIMAL LESION AND THE DEVICE WAS UNABLE TO CROSS EVEN AFTER SEVERAL ATTEMPTS. WHEN THE DEVICE WAS REMOVED FORM THE PATIENT, IT WAS NOTICED THAT THE STENT GOT LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00X38MM SYNERGY" DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, RESISTANCE WAS ENCOUNTERED IN THE PROXIMAL LESION AND THE DEVICE WAS UNABLE TO CROSS EVEN AFTER SEVERAL ATTEMPTS. WHEN THE DEVICE WAS REMOVED FORM THE PATIENT, IT WAS NOTICED THAT THE STENT GOT LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY" STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755068 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926238300 18635724

    Patients

    Seq Age Sex Outcome Treatment
    1