BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 3012533 · Received March 20, 2013

    Report

    Report Number
    1226348-2013-20049
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 28, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE COIL EMBOLIZATION PROCEDURE, THE DELTAPAQ CERECYTE MICROCOIL ((B)(4)) WAS FINISHED WITHOUT ANY ISSUE, BUT A ONE MONTH FOLLOW-UP CT AND MRI IMAGES SHOWED SCATTERED EMBOLIC MATERIALS WITHOUT SYMPTOM. THE PHYSICIAN SUSPECTED THE CERECYTE PGA COATING MATERIAL COULD BE ONE OF THE POSSIBILITIES OF THE EMBOLIC MATERIALS ON THE CT AND MRI IMAGES. NO PART OF THE COIL PROTRUDED INTO THE PARENT ARTERY. THE LONG TERM CARE OF THE PATIENT CONSIST OF CT/MRI (ONE MONTH FOLLOW UP), AND IT IS UNKNOWN IF OTHER DEVICES WERE UTILIZED TO TREAT THE PATIENT. THE PATIENT DOES NOT HAVE HISTORY OF HYPERCOAGULATION OR ALLERGIES. IT WAS UNKNOWN THE MEDICATIONS GIVEN PRE, INTRA AND POST PROCEDURE, AND THE PATIENT WAS NO COMPLIANT WITH DISCHARGED MEDICATIONS. THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. BASED ON THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT; HOWEVER, THERE ARE POTENTIAL INHERENT RISKS ASSOCIATED WITH THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. ADDITIONALLY, THE DELTAPAQ CERECYTE MICROCOIL ARE NOT COATED WITH HYDROPHILIC MATERIAL, AND THERE IS NO INDICATION IN THE REPORTED INFORMATION OF THE DEVICE HISTORY REVIEW THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS NEEDED.

    Additional Manufacturer Narrative · 1

    NO HOLTER MONITOR WAS EVER DONE, AND THE PATIENT DID NOT HAVE ANY MEDICAL PROBLEMS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY ISSUE. NO FURTHER INFORMATION WILL BE FORTHCOMING FOR THIS REPORT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AFTER THE COIL EMBOLIZATION PROCEDURE, THE DELTAPAQ CERECYTE MICROCOIL ((B)(4)) WAS FINISHED WITHOUT ANY ISSUE, BUT A ONE MONTH FOLLOW-UP CT AND MRI IMAGES SHOWED SCATTERED EMBOLIC MATERIALS WITHOUT SYMPTOM. THE PHYSICIAN SUSPECTED THE CERECYTE PGA COATING MATERIAL COULD BE ONE OF THE POSSIBILITIES OF THE EMBOLIC MATERIALS ON THE CT AND MRI IMAGES. NO PART OF THE COIL PROTRUDED INTO THE PARENT ARTERY. THE LONG TERM CARE OF THE PATIENT CONSIST OF CT/MRI (ONE MONTH FOLLOW UP), AND IT IS UNKNOWN IF OTHER DEVICES WERE UTILIZED TO TREAT THE PATIENT. THE PATIENT DOES NOT HAVE HISTORY OF HYPERCOAGULATION OR ALLERGIES. IT WAS UNKNOWN THE MEDICATIONS GIVEN PRE, INTRA AND POST PROCEDURE, AND THE PATIENT WAS NO COMPLIANT WITH DISCHARGED MEDICATIONS. THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115033 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C10617

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening