BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 11990708 · Received June 14, 2021

    Report

    Report Number
    3002808486-2021-01345
    Event Type
    Injury
    Date Received
    June 14, 2021
    Report Date
    June 14, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K150964. SUMMARY OF INVESTIGATIONAL FINDINGS: AN ARTICLE DESCRIBED THAT THE COIL DID NOT SIT PROPERLY IN THE AORTIC AMPULLA. THE COIL WAS REMOVED AND ANOTHER SMALLER (5MM) COOK COIL WAS SUCCESSFULLY PLACED. NO PRODUCT WAS RETURNED FOR ANALYSIS AND BASED ON THE INFORMATION PROVIDED WITH THE ARTICLE ONLY, IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE 6.5MM COIL TO ¿NOT SIT PROPERLY¿. HOWEVER, SINCE REPLACEMENT COIL IS SMALLER (5MM) REFERENCE IS MADE TO IFU CAUTIONING THAT AN ANGIOGRAM MUST BE PERFORMED PRIOR TO EMBOLIZATION FOR MEASURING LENGTH AND DIAMETER OF THE PDA. IFU ALSO CAUTION THAT IT IS IMPORTANT TO FOLLOW THE LOADING PROCEDURE CAREFULLY TO AVOID COMPLICATIONS DURING ATTACHMENT AND DETACHMENT OF THE COIL, THUS ENSURING A PROPER POSITION. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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 · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A 6.5PDA5 COIL WAS DEPLOYED BUT WAS NOT ANCHORED PROPERLY IN THE AORTIC AMPULLA AND THEREFORE, WAS REMOVED. A 5PDA5 COIL WAS PLACED IN THE DUCTUS ARTERIOSUS. JUST AS THE WIRE WAS BEING ROTATED TO RELEASE THE COIL, THE COIL ROTATED AND MIGRATED TO THE LEFT PULMONARY ARTERY. PATIENT OUTCOME: THE COIL MIGRATED TO THE LEFT PULMONARY ARTERY AS THE COIL WAS RELEASED. THE COIL LAID PARALLEL TO THE VESSEL AND DESPITE MULTIPLE ATTEMPTS IT COULD NOT BE RETRIEVED. AT THIS POINT, THE DISTAL LEFT PULMONARY ARTERY WAS FOUND TO BE ESSENTIALLY OCCLUDED AND, THEREFORE, A THORACOTOMY WAS PERFORMED IN ORDER TO RETRIEVE THE COIL SURGICALLY COMBINED WITH PDA CLOSURE. THE PATIENT RECOVERED WELL FROM SURGERY AND WAS DISCHARGED FROM THE HOSPITAL ON DAY 3. AT FOLLOW-UP 6 MONTHS LATER, NO COMPLICATIONS WERE REPORTED. CONVERSION TO OPEN REPAIR TO RETRIEVE COIL THAT MIGRATED AND ESSENTIALLY OCCLUDED THE PULMONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890177 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO