BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VORTX 18 FIBERED PLATINUM COIL

    MDR report key: 2003428 · Received March 1, 2011

    Report

    Report Number
    2134265-2011-00696
    Event Type
    Injury
    Date Received
    March 1, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K914786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#2134265-2011-00697,2134265-2011-00698, 2134265-2011-00700, 2134265-2011-00415. IT WAS REPORTED THAT FOLLOWING A COIL PLACEMENT PROCEDURE AN ALLERGIC REACTION OCCURRED. DURING A DRAINING PROCEDURE FOR A LIVER ABCESS, BLEEDING OCCURRED AT THE LEFT HEPATIC ARTERY. EMBOLIZATION WAS PERFORMED WITH THE DEPLOYMENT OF (3) VORTX-18 DIAMOND 3MM/3.3 MM COILS AND (2) VORTX-18 DIAMOND 4MM/3.7 MM COILS. THE EMBOLIZATION ALSO UTILIZED N-BUTYL CYANOACRYLATE (GLUE). "SEVERAL" DAYS LATER, THE PATIENT EXPERIENCED SWOLLEN LYMPH NODES AND FEVER (38 DEGREES C). AN EOSINOPHIL INCREASE OCCURRED. THE PHYSICIAN CONFIRMED THAT A TYPE 3 OR TYPE 4 ALLERGIC REACTION OCCURRED. NO ADDITIONAL PATIENT COMPLICATIONS HAVE OCCURRED AND THE PATIENT REMAINS HOSPITALIZED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS DISCHARGED AFTER THE IMPLANT PROCEDURE AND RETURNED TO THE FACILITY ON AN UNSPECIFIED DATE WITH THE PREVIOUSLY REPORTED SYMPTOMS. THE PATIENT WAS HOSPITALIZED FOR 8 WEEKS FOLLOWING THE PROCEDURE. THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND LYMPH NODE SWELLING ONE WEEK AFTER THE PROCEDURE. THE PATIENT WAS NOTED TO HAVE A FEVER 4 WEEKS FOLLOWING THE PROCEDURE. THE PATIENT HAS BEEN DISCHARGED AND HAS NO SYMPTOMS NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VORTX 18 FIBERED PLATINUM COIL DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M0013822030 13502287

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other (2) VORTX-18 DIAMOND 4MM/3.7 MM COILS| (2) VORTX-18 DIAMOND 3MM/3.3 MM COILS