BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MREYE EMBOLIZATION COIL

    MDR report key: 21801002 · Received April 8, 2025

    Report

    Report Number
    1820334-2025-00364
    Event Type
    Injury
    Date Received
    April 8, 2025
    Report Date
    September 25, 2025
    Manufacturer
    COOK INC
    Product Code
    KRD
    PMA / PMN Number
    K150931
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. B3 - DATE OF EVENT: 2022 H3 - DEVICE EVALUATED BY MFG?: DEVICE NOT RETURNED 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT MREYE EMBOLIZATION COILS MIGRATED FOLLOWING THEIR PLACEMENT IN 64-YEAR-OLD FEMALE PATIENT AS A RESULT OF HEPATIC INFARCT. THE PATIENT UNDERWENT A PANCREATODUODENECTOMY WITH PORTAL VEIN AND SMA RECONSTRUCTION WITH A GRAFT. THE POST-SURGICAL RECOVERY WAS COMPLICATED BY SEPSIS DUE TO HEPATIC ABSCESSES FROM AN INFECTED PORT AND A GJ ANASTOMOTIC ULCER. THIRTEEN DAYS AFTER SURGERY, CHILLS, FATIGUE AND LEFT ABDOMINAL PAIN EXPERIENCED BY THE PATIENT LED TO A CT SCAN. THE SCAN REVEALED NARROWING OF THE PORTAL SMV, PROMPTING A TRANSHEPATIC PORTAL VEIN VENOGRAM WITH STENTING AND COIL PLACEMENT TO OCCLUDE THE TRANSHEPATIC PARENCHYMAL TRACT. INITIALLY, THERE WERE NO COMPLICATIONS. HOWEVER, FOUR DAYS LATER, A CT SCAN SHOWED A NEW AREA OF LIVER HYPO-ENHANCEMENT, INDICATING A DEVELOPING HEPATIC INFARCT PERIPHERAL TO THE INFERIOR RIGHT HEPATIC LOBE COIL EMBOLIZATION. EIGHT DAYS POST-PROCEDURE, ANOTHER CT SCAN REVEALED AN AIR-FLUID COLLECTION DISTAL TO THE EMBOLIZED TRANSHEPATIC TRACT, MEASURING 3/8 X 5.6 X 6/5 CM. THE COLLECTION CONTAINED THE EMBOLIZATION COILS, WHICH WERE NOW SCATTERED THROUGHOUT. TWENTY-ONE DAYS AFTER THE PROCEDURE, THREE COILS WERE SUCCESSFULLY REMOVED VIA SHEATH ACCESS AND A STONE BASKET DURING AN ABSCESS DRAIN EXCHANGE. BY TWENTY-NINE DAYS POST-COIL PLACEMENT, A FOLLOW-UP CT SHOWED THE EVOLUTION OF THE HEPATIC INFARCT INTO A WELL-DEFINED BILOBED FLUID COLLECTION. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. REVIEWS OF THE DOCUMENTATION, INCLUDING THE QUALITY CONTROL PROCEDURES AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED 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. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE CURRENTLY IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. AN EXPANDED SALES SEARCH TO THE CUSTOMER WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU [T_CE_IMWCE_REV6] PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: PRECAUTIONS "PERFORM AN ANGIOGRAM PRIOR TO EMBOLIZATION TO DETERMINE CORRECT CATHETER POSITION.¿ BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT PATIENT PRE-EXISTING CONDITIONS AND PROCEDURAL COMPLICATIONS CONTRIBUTED TO THE COMPLAINT EVENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 REPORTED THAT MREYE EMBOLIZATION COILS MIGRATED FOLLOWING THEIR PLACEMENT IN 64-YEAR-OLD FEMALE PATIENT AS A RESULT OF HEPATIC INFARCT. THE PATIENT UNDERWENT A PANCREATODUODENECTOMY WITH PORTAL VEIN AND SMA RECONSTRUCTION WITH A GRAFT. THE POST-SURGICAL RECOVERY WAS COMPLICATED BY SEPSIS DUE TO HEPATIC ABSCESSES FROM AN INFECTED PORT AND A GJ ANASTOMOTIC ULCER. THIRTEEN DAYS AFTER SURGERY, CHILLS, FATIGUE AND LEFT ABDOMINAL PAIN EXPERIENCED BY THE PATIENT LED TO A CT SCAN. THE SCAN REVEALED NARROWING OF THE PORTAL SMV, PROMPTING A TRANSHEPATIC PORTAL VEIN VENOGRAM WITH STENTING AND COIL PLACEMENT TO OCCLUDE THE TRANSHEPATIC PARENCHYMAL TRACT. INITIALLY, THERE WERE NO COMPLICATIONS. HOWEVER, FOUR DAYS LATER, A CT SCAN SHOWED A NEW AREA OF LIVER HYPO-ENHANCEMENT, INDICATING A DEVELOPING HEPATIC INFARCT PERIPHERAL TO THE INFERIOR RIGHT HEPATIC LOBE COIL EMBOLIZATION. EIGHT DAYS POST-PROCEDURE, ANOTHER CT SCAN REVEALED AN AIR-FLUID COLLECTION DISTAL TO THE EMBOLIZED TRANSHEPATIC TRACT, MEASURING 3/8 X 5.6 X 6/5 CM. THE COLLECTION CONTAINED THE EMBOLIZATION COILS, WHICH WERE NOW SCATTERED THROUGHOUT. TWENTY-ONE DAYS AFTER THE PROCEDURE, THREE COILS WERE SUCCESSFULLY REMOVED VIA SHEATH ACCESS AND A STONE BASKET DURING AN ABSCESS DRAIN EXCHANGE. BY TWENTY-NINE DAYS POST-COIL PLACEMENT, A FOLLOW-UP CT SHOWED THE EVOLUTION OF THE HEPATIC INFARCT INTO A WELL-DEFINED BILOBED FLUID COLLECTION. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727808 MREYE EMBOLIZATION COIL KRD, DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD COOK INC G42409

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention