BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY STENT

    MDR report key: 6078579 · Received November 2, 2016

    Report

    Report Number
    MW5065811
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    September 17, 2016
    Report Date
    October 24, 2016
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CABG (RIMA TO LIMA), FOREIGN BODY EXTRACTION. THE PT PRESENTED WITH A MYOCARDIAL INFARCTION. HE UNDERWENT CARDIAC CATHETERIZATION WITH PERCUTANEOUS INTERVENTION TO HIS RCA. THE LESION WAS PREDILATED WITH A 2.5 X 12 MM PRE DILATION BALLOON. A 3.5 X 16 MM SYNERGY DRUG-ELUTING STENT WAS PLACED AT THE LESION AND DEPLOYED. NEXT, THE PROXIMAL PORTION OF THE RCA WAS STENTED OVERLAPPING THE FIRST STENT WITH A 3.5 X 8 MM SYNERGY DRUG-ELUTING STENT. DISTAL AND OVERLAPPING TO THE 3.5 X 16 MM STENT, A 3.0 X 8 MM SYNERGY DRUG-ELUTING STENT WAS DEPLOYED. THE STENTS WERE POSTULATED WITH A 3.5 MM NONCOMPLIANT BALLOON FOLLOWED BY A 4.0 MM NONCOMPLIANT BALLOON. ANGIOGRAPHY SHOWED THE STENTS APPEARED TO BE WELL-EXPANDED WITH NO EVIDENCE OF DISSECTIONS AND TIMI 3 FLOW THROUGHOUT THE CORONARY ARTERY. NEXT, THE GUIDEWIRE WAS ATTEMPTED TO BE REMOVED FOR FINAL ANGIOGRAPHY UNDER FLUOROSCOPY. AT THIS POINT, AFTER INITIAL WITHDRAWAL OF THE GUIDEWIRE, THE VERY DISTAL PORTION OF THE RADIOPAQUE TIP OF THE GUIDEWIRE APPEARED TO GET STUCK UNDER THE DISTAL EDGE OF THE MOST DISTAL STENT (SYNERGY 3.0X 8MM). THE STENT ACCORDIONED BACK INTO THE SECOND STENT (SYNERGY 3.5 X 16 MM) AND THE DISTAL TIP OF THE GUIDEWIRE APPEARED TO BE LODGED WITHIN THE STENT AND UNABLE TO BE REMOVED. NEXT, RELEASE OF THIS WIRE WAS ATTEMPTED USING RX 1.5 MM BALLOON. THE WIRE WOULD NOT RELEASE. FINALLY, THE DISTAL TIP OF THE WIRE DID BREAK AND THE WIRE WAS ABLE TO BE REMOVED. UNFORTUNATELY, THERE WAS A RETAINED PORTION OF THE WIRE TIP WITHIN THE ACCORDIONED RCA STENT. THE CASE WAS ABLE TO BE COMPLETED. F/U CARDIAC CTA SHOWED A LONGER THAN EXPECTED WIRE ATTACHED TO THE STENT GOING INTO THE RIGHT AXILLARY. SEVERAL DAYS LATER, THE PT UNDERWENT CABG AND THE REMOVAL OF STENT AND WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725907 SYNERGY STENT SYNERGY 3.5 X 16MM NIQ BOSTON SCIENTIFIC 19174128
    725908 SYNERGY STENT SYNERGY 3.5 X 8MM NIQ BOSTON SCIENTIFIC 18459546
    725909 SYNERGY STENT SYNERGY 3.0 X 8MM NIQ BOSTON SCIENTIFIC 18456136
    726010 RUNTHROUGH NS RUNTHROUGH NS DQX TERUMO 160701

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| O| R