BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY MEGATRON

    MDR report key: 25319691 · Received May 28, 2026

    Report

    Report Number
    2124215-2026-28667
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    October 20, 2021
    Report Date
    May 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    UDI-DI
    08714729985402
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SELVARAJ, K., YUSOF, H.M., ERNG, T. AND GHAPAR, A.K.A. (2025), CORONARY STENT LOSS RETRIEVAL USING PULMONARY BIOPSY FORCEPS VIA TRANSRADIAL APPROACH - A CASE SERIES. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 106: 1310-1314. HTTPS://DOI.ORG/10.1002/CCD.31674.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VIA LITERATURE ARTICLE THAT STENT DISLODGEMENT OCCURRED RESULTING IN ADDITIONAL INTERVENTION. THE PATIENT PRESENTED FOR ELECTIVE PERCUTANEOUS CORONARY INTERVENTION. THE CHRONIC TOTAL OCCLUSION (CTO) TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE CTO LESION WAS SUCCESSFULLY CROSSED AND PREDILATED WITH 3.0 MM NC AND 3.0 MM CUTTING BALLOONS. IVUS SHOWED NAPKIN-RING CALCIFICATION IN DISTAL RCA, WITH NODULAR CALCIFICATION AND DISSECTION IN MID RCA NECESSITATING TARGETED ORBITAL ATHERECTOMY OF THE DISTAL RCA FOLLOWED BY 3.5 NC BALLOON PREDILATION. DISTAL RCA WAS STENTED WITH 3.5X38 MM DES OVERLAPPING WITH A 4.0 X 28 MM DES IN PROXIMAL-MID RCA. DUE TO PROXIMAL STENT EDGE DISSECTION, A 5.0 X 20 MM SYNERGY MEGATRON EVEROLIMUS-ELUTING STENT WAS INITIALLY AIMED FOR DEPLOYMENT FROM THE OSTIAL RCA. HOWEVER, DURING DEPLOYMENT, THE PATIENT TOOK A DEEP BREATH DISLODGING THE STENT INTO THE AORTA. LOW PRESSURE STENT BALLOON INFLATION WAS ABLE TO GRIP THE STENT FOR RETRACTION INTO THE RADIAL ARTERY. LONGITUDINAL COMPRESSION OF THE LARGE 5.0 STENT WAS NOTED WITHIN RADIAL ARTERY. THE RAFR TECHNIQUE WAS SUCCESSFULLY APPLIED. DEPLOYMENT OF PULMONARY BIOPSY FORCEPS FOR COMPLETE STENT RETRIEVAL. WE THEN PROCEEDED WITH OSTIAL RCA STENTING USING THE SAME RADIAL SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536086 SYNERGY MEGATRON CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 08714729985402

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention