BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 10805351 · Received November 6, 2020

    Report

    Report Number
    1820334-2020-02043
    Event Type
    Injury
    Date Received
    November 6, 2020
    Report Date
    April 14, 2021
    Manufacturer
    COOK INC
    Product Code
    KRD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: BUBALO LAW PLC IN THE UNITED STATES INFORMED COOK OF AN INCIDENT INVOLVING NESTER PLATINUM EMBOLIZATION COILS. ON OR AROUND (B)(6) 2008 A PATIENT HAD A VARICOCELE EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE PATIENT HAD NESTER EMBOLIZATION COILS IMPLANTED. THE COILS ARE FROM UNKNOWN LOT NUMBERS. SHORTLY, AFTER THE PROCEDURE, THE PATIENT EXPERIENCED MULTIPLE HEALTH ISSUES INCLUDING CHRONIC PELVIC PAIN, PELVIC AND PERINEAL PAIN, FULL HYSTERECTOMY AND AN IMMUNE DISORDER. ON (B)(6) 2017, THE PATIENT HAD THE COILS REMOVED DUE TO CHRONIC PELVIC AND ADNOMINAL PAIN. IT IS ALLEGED THAT SMALL PIECES OF THE COIL WERE LEFT INSIDE BECAUSE IT WAS TOO DANGEROUS TO REMOVE AS THEY WERE GOING TOWARDS THE AORTA. AFTER THE COILS WERE REMOVED, THE PATIENT BEGAN TO FEEL RELIEF. THE PATIENT HAD PRE-EXISTING CONDITION OF PELVIC CONGESTION SYNDROME. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. DUE TO THIS, NO DIMENSIONAL, VISUAL, OR FUNCTIONAL VERIFICATIONS COULD BE COMPLETED. A DEVICE MASTER RECORD (DMR) REVIEW WAS PERFORMED, AND DEVICE MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES ASSOCIATED WITH THE COMPLAINT WERE IDENTIFIED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY POTENTIALLY RELATED FAILURE MODES PRIOR TO DISTRIBUTION. THE DEVICE'S DESIGN HISTORY FILES (DHF) WERE REVIEWED AND DETERMINED THAT BIOCOMPATIBILITY TESTING OF NESTER COILS HAS BEEN COMPLETED AS DESCRIBED IN ISO STANDARDS AND THAT THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. COOK ALSO REVIEWED PRODUCT LABELING. INSTRUCTIONS FOR USE [IFU], ¿NESTER® EMBOLIZATION COILS¿ [T_CE_NEC_REV4], PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: DEVICE DESCRIPTION: "NESTER EMBOLIZATION COILS ARE MADE OF PLATINUM WITH SPACED SYNTHETIC FIBERS, AND ARE SUPPLIED PRELOADED IN A LOADING CARTRIDGE. THEY ARE DESIGNED TO BE DELIVERED TO THE TARGET VESSEL USING A SOFT, STRAIGHT WIRE GUIDE THROUGH A STANDARD ANGIOGRAPHIC CATHETER." WARNINGS: "POSITIONING OF THE EMBOLIZATION COILS SHOULD BE DONE WITH PARTICULAR CARE. COILS SHOULD NOT BE LEFT TOO CLOSE TO THE INLETS OF ARTERIES AND SHOULD BE INTERMESHED WITH PREVIOUSLY PLACED COILS IF POSSIBLE. A MINIMAL BUT SUFFICIENT ARTERIAL BLOOD FLOW SHOULD REMAIN TO HOLD THE COILS AGAINST THE PREVIOUSLY PLACED COILS UNTIL A SOLID CLOT ENSURES PERMANENT FIXATION. THE PURPOSE OF THESE SUGGESTIONS IS TO MINIMIZE THE POSSIBILITY OF LOOSE COILS BECOMING DISLODGED AND OBSTRUCTION A NORMAL AND ESSENTIAL ARTERIAL CHANNEL." INSTRUCTIONS FOR USE: "PERFORM A FINAL ANGIOGRAM TO CONFIRM THE COIL POSITION WITHIN THE TARGET VESSEL." HOW SUPPLIED: "SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DUE TO LACK OF LOT INFORMATION. HOWEVER, COOK WAS INFORMED OF FACILITIES INVOLVED IN THE CASE. IT IS UNKNOWN WHICH FACILITY OR IF THESE FACILITIES ARE WHERE THE COILS WERE IMPLANTED. A GLOBAL SALES SHIPMENT REPORT WAS CONDUCTED FROM 13MARCH2020 THROUGH 13MARCH2008 FOR NESTER COILS. COOK WAS UNABLE TO NARROW DOWN POTENTIAL LOT NUMBERS. THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE SOURCE OF THE PATIENT'S ADVERSE EFFECTS COULD NOT BE DETERMINED. FINDINGS OF THIS INVESTIGATION REVEALED NO EVIDENCE TO SUGGEST THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THE INVESTIGATION CONCLUSION FOR THIS COMPLAINT IS CAUSE TRACED TO THE PATIENT FOR AN ADVERSE PHYSIOLOGICAL RESPONSE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    IT WAS DISCOVERED THAT CONTAINED WITHIN A SPREADSHEET SUPPLIED BY THE PATIENT'S LEGAL TEAM WAS A STATEMENT ALLEGING THE FOLLOWING: "AFTER REMOVAL, SMALL PIECES OF COIL WERE LEFT INSIDE BECAUSE IT WAS TOO DANGEROUS TO REMOVE AS THEY WERE GOING TOWARDS THE AORTA." NO IMAGING, PROCEDURAL NOTES, OR ADDITIONAL DETAILS REGARDING THIS OCCURRENCE AND ALLEGED POSSIBLE SEPARATION ARE AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: ESQUIRE. PMA/510(K) #: PREAMENDMENT OR K153778. (B)(4). 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

    IT WAS REPORTED, "ON OR ABOUT (B)(6) 2008, (PATIENT) HAD A VARICOCELE EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, (PATIENT) HAD NESTER EMBOLIZATION COILS IMPLANTED." THE NUMBER OF NESTER COILS IMPLANTED IS CURRENTLY UNKNOWN. SHORTLY AFTER THE PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED A LITANY OF HEALTH ISSUES, INCLUDING: "CHRONIC PELVIC PAIN, PELVIC AND PERINEAL PAIN, FULL HYSTERECTOMY, AND IMMUNE DISORDER." "ON OR ABOUT (B)(6) 2017, (PATIENT) HAD THE COILS REMOVED DUE CHRONIC PELVIC AND ABDOMINAL PAIN. AFTER THE COILS WERE REMOVED, (PATIENT) BEGAN TO FEEL RELIEF." NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270455 UNKNOWN KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R