BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1951126 · Received December 30, 2010

    Report

    Report Number
    MW5018853
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    April 15, 2010
    Report Date
    December 30, 2010
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT HAD 70% MID RCA STENOSIS STENTED WITH 3.0X38 TAXUS LIBERTE. DISCHARGED ON ASA AND PLAVIX. ON (B)(6) 2010, PT ACTUALLY ADMITTED ELECTIVELY FOR STAGED PROCEDURE TO LAD. THIS WAS SUCCESSFUL, HOWEVER PT BEGAN TO COMPLAIN OF SOB, TACHYCARDIA, AND BECAME HYPOTENSIVE. REPEAT FILMS VERIFIED NO COMPLICATIONS IN THE LAD. THEREFORE IT WAS DECIDED TO ANGIOGRAPHICALLY CONFIRM NO OTHER SIGNIFICANT DISEASE. FILMS REVEAL A SUBACUTE THROMBOSIS OF MID RCA JUST DISTAL TO PREVIOUSLY PLACED STENTS. PT CONTINUED WITH SYMPTOMS, RAPID RESPONSE TEAM CALLED FOR INTUBATION. APEX 2.0X15 USED TO DILATE. A 3.0X24 TAXUS LIBERTE WOULDN'T CROSS, 3.0X30 VOYAGER USED TO DILATE. STENT STILL UNABLE TO CROSS. A 3.0X23 XIENCE ALSO UNABLE TO CROSS. A 3.5X30 VOYAGER USED FOR MULTIPLE OVERLAPPING INFLATIONS. NOW A 3.0X15 XIENCE ABLE TO CROSS THROUGH MID VESSEL AND DEPLOYED DISTAL TO EXISTING STENTS. FINAL FILMS REVEAL 0% RESIDUAL STENOSIS. THE PT WAS HEMODYNAMICALLY STABLE FOLLOWING STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC TAXUS LIBERTE LONG MONORAIL NIQ 12816546

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability