BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NESTER PLATINUM EMBOLIZATION COIL

    MDR report key: 7686164 · Received July 13, 2018

    Report

    Report Number
    1820334-2018-02068
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    June 21, 2018
    Report Date
    October 9, 2018
    Manufacturer
    COOK INC
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. METHODS CODE: (4114) DEVICE NOT RETURNED. RESULTS CODE: (3221) NO FINDINGS AVAILABLE. CONCLUSION CODE: (4315) CAUSE NOT ESTABLISHED. INVESTIGATION - EVALUATION A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE PATIENT¿S PREVIOUS CONDITION COULD BE RELATED TO THE ADVERSE EVENT, BUT CANNOT BE CONFIRMED AS THE ROOT CAUSE AT THIS TIME. NO ADDITIONAL EVALUATION OF THE DEVICE WAS ABLE TO BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED, AND IMAGES WERE NOT PROVIDED. WITHOUT VISUAL, DIMENSIONAL, AND/OR FUNCTIONAL TESTING OF THE PRODUCT, WE ARE UNABLE TO DETERMINE IF THIS COMPLAINT WAS DRIVEN BY A PROCEDURAL OR DEVICE RELATED CAUSE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: PRE-AMENDMENT PER NESTER EMBOLIZATION COILS. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED FROM PUBLIC WEBSITE - 22JUN2018 - "ARE THERE ANY REPORTS OF FEVERS IN PATIENTS WHO HAVE RECEIVE NESTER EMBOLIZATION COILS?" THE FOLLOWING INQUIRY WAS MADE BY A PHYSICIAN ON 22JUN2018 WITH REGARDS TO NESTER EMBOLIZATION COILS: "ARE THERE ANY REPORTS OF FEVERS IN PATIENTS WHO HAVE RECEIVE NESTER EMBOLIZATION COILS". AFTER CONTACTING THE PHYSICIAN, IT WAS REPORTED A PATIENT WAS COUGHING UP BLOOD DUE TO AN ANEURYSM ON HER RIGHT BRONCHIAL ARTERY. THE PATIENT UNDERWENT INTERVENTIONAL RADIOLOGY TREATMENT WHERE SEVERAL NESTER EMBOLIZATION COILS (8 MM - MEDWATCH 1820334-2018-02066, 6 MM - MEDWATCH 1820334-2018-02067, AND 5 MM - THIS REPORT) WERE PLACED IN THE PATIENT'S RIGHT BRONCHIAL ARTERY. AFTER THIS TREATMENT, THE PATIENT WAS STABLE WITH GOOD RESPIRATION AND NO LONGER COUGHING UP BLOOD. SINCE THE PROCEDURE, THE PATIENT HAS HAD A FEVER WITH NO CLEAR EVIDENCE OF INFECTION. THE PATIENT'S RECORDED TEMPERATURE, MEDICAL HISTORY AND SURGICAL CHART WERE NOT PROVIDED. AS REPORTED, THE CAUSE OF THE PATIENT'S FEVER IS UNCLEAR AND THERE IS NO EVIDENCE THE NESTER EMBOLIZATION COILS CAUSED OR CONTRIBUTED TO THIS ADVERSE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528855 NESTER PLATINUM EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other