BEUDAMED
    FDA Adverse Event Death Summary report: N

    KRD DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

    MDR report key: 23708543 · Received December 3, 2025

    Report

    Report Number
    1820334-2025-01497
    Event Type
    Death
    Date Received
    December 3, 2025
    Date of Event
    October 22, 2025
    Report Date
    May 5, 2026
    Manufacturer
    COOK INC
    Product Code
    KRD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT AN UNKNOWN PUSHABLE EMBOLIZATION COIL MIGRATED. THE DEVICE WAS REQUIRED FOR A 40-YEAR-OLD FEMALE TO EMBOLIZE THE RIGHT OVARIAN VEIN TO TREAT PELVIC CONGESTION SYNDROME. THE RIGHT OVARIAN VEIN MEASURED 8MM NEAR ITS ORIGIN FROM THE INFERIOR VENA CAVA (IVC) AND MEASURED 6MM MORE DISTAL TO THE IVC. THE PROCEDURE WAS PERFORMED UNDER CONSCIOUS SEDATION WITH REGISTERED NURSE MONITORING. AN ATTENDING PHYSICIAN PERFORMED THE PROCEDURE, AND A RESIDENT PHYSICIAN WAS PRESENT. NO COOK REPRESENTATIVE ATTENDED THE CASE. THE FIRST COIL PLACED DURING EMBOLIZATION WAS 8MM IN DIAMETER BY 14MM LONG. NEXT, 10MM DIAMETER COILS WERE PLACED. IT IS UNKNOWN HOW MANY OF THESE COILS WERE USED. THE LAST COIL PLACED WAS AN 8MM COIL OF UNKNOWN LENGTH. WHEN REMOVING THE DELIVERY CATHETER AFTER THE LAST COIL WAS DEPLOYED, THE COIL MIGRATED TO THE HEART. AN ATTEMPT TO RETRIEVE THE COIL WITH A SNARE RESULTED IN DISSECTION/PERFORATION OF THE HEART. THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AT THE PROCEDURE FACILITY AND WAS THEN TRANSFERRED TO ANOTHER FACILITY. SOMETIME AFTER ARRIVING AT THE NEW FACILITY, AN OPEN ABDOMINAL/CHEST PROCEDURE WAS PERFORMED. LATER, THE PATIENT EXPIRED ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION IS AVAILABLE. REVIEWS OF THE DOCUMENTATION INCLUDING QUALITY CONTROL PROCEDURES AND INSTRUCTIONS FOR USE (IFU) OF THE DEVICE WERE COMPLETED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE CATALOG NUMBER WAS NOT PROVIDED FOR THE COMPLAINT DEVICE. COOK REVIEWED OVERALL SALES AND ASSUMED THE DEVICE TO BE A NESTER EMBOLIZATION COIL FOR THIS INVESTIGATION. A REVIEW OF THE DEVICE MASTER RECORD (DMR) FOUND THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE COMPLETED DUE TO THE LACK OF LOT INFORMATION PROVIDED BY THE FACILITY. AN EXPANDED SALES SEARCH FOR THIS CUSTOMER WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. COOK ALSO REVIEWED PRODUCT LABELING. THE CURRENT INSTRUCTIONS FOR USE [T_NEC2_REV0] STATE THE FOLLOWING: ¿CONTRAINDICATIONS, NONE KNOWN. WARNINGS: POSITIONING OF EMBOLIZATION COILS AND MICROCOILS 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 OBSTRUCTING A NORMAL AND ESSENTIAL ARTERIAL CHANNEL. COIL DELIVERY TECHNIQUE AND COIL SIZE SELECTION IN GENERAL, THE FIRST COIL SELECTED SHOULD HAVE A DIAMETER THAT IS 20% LARGER, OR AT LEAST 2 MM OVERSIZED, THAN THE VESSEL THAT IS BEING OCCLUDED.¿ EVIDENCE PROVIDED UPON REVIEW OF THE DMR AND IFU, SUGGESTS THAT THE DEVICE WAS NOT MANUFACTURED OUT OF SPECIFICATION AND THAT THERE ARE NO NONCONFORMING PRODUCTS IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF THIS INVESTIGATION, IT WAS CONCLUDED THAT NON-DEVICE-RELATED FACTORS CONTRIBUTED TO THE REPORTED EVENT. IT IS LIKELY THAT UNDER SIZING OF THE COIL CONTRIBUTED TO THE MIGRATION, AND THE PATIENT¿S CONDITION CONTRIBUTED TO THE SEVERE COMPLICATIONS AND SUBSEQUENT DEATH. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. 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.

    Additional Manufacturer Narrative · 0

    D1: BRAND NAME: THE IDENTITY OF THE DEVICE IS UNKNOWN; HOWEVER, BASED ON AVAILABLE INFORMATION, THE DEVICE IS EITHER AN MREYE® EMBOLIZATION COIL OR A NESTER® EMBOLIZATION COIL. G4: PMA/510(K) #: MREYE - K150931; NESTER - K153778. H3: DEVICE EVALUATED BY MFG.? NO. DEVICE RETURN TO MANUFACTURER. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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

    NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNKNOWN PUSHABLE EMBOLIZATION COIL MIGRATED. THE DEVICE WAS REQUIRED FOR A 40-YEAR-OLD FEMALE TO EMBOLIZE THE RIGHT OVARIAN VEIN TO TREAT PELVIC CONGESTION SYNDROME. THE RIGHT OVARIAN VEIN MEASURED 8MM NEAR ITS ORIGIN FROM THE INFERIOR VENA CAVA (IVC) AND MEASURED 6MM MORE DISTAL TO THE IVC. THE PROCEDURE WAS PERFORMED UNDER CONSCIOUS SEDATION WITH REGISTERED NURSE MONITORING. AN ATTENDING PHYSICIAN PERFORMED THE PROCEDURE, AND A RESIDENT PHYSICIAN WAS PRESENT. NO COOK REPRESENTATIVE ATTENDED THE CASE. THE FIRST COIL PLACED DURING EMBOLIZATION WAS 8MM IN DIAMETER BY 14MM LONG. NEXT, 10MM DIAMETER COILS WERE PLACED. IT IS UNKNOWN HOW MANY OF THESE COILS WERE USED. THE LAST COIL PLACED WAS AN 8MM COIL OF UNKNOWN LENGTH. WHEN REMOVING THE DELIVERY CATHETER AFTER THE LAST COIL WAS DEPLOYED, THE COIL MIGRATED TO THE HEART. AN ATTEMPT TO RETRIEVE THE COIL WITH A SNARE RESULTED IN DISSECTION/PERFORATION OF THE HEART. THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AT THE PROCEDURE FACILITY AND WAS THEN TRANSFERRED TO ANOTHER FACILITY. SOMETIME AFTER ARRIVING AT THE NEW FACILITY, AN OPEN ABDOMINAL/CHEST PROCEDURE WAS PERFORMED. LATER, THE PATIENT EXPIRED ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609246 KRD DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Death| R