BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CERECYTE MICROCOIL

    MDR report key: 6639777 · Received June 14, 2017

    Report

    Report Number
    2954740-2017-00134
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    January 1, 2008
    Report Date
    May 23, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    PMA / PMN Number
    K022420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL/FINAL MDR IS THE ONLY REPORT BEING SUBMITTED FOR MFR #2954740-2017-00134. PROCODES; KRD/HCG. UDI: UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE. CONCLUSION: THE DEVICES ARE NOT AVAILABLE FOR ANALYSIS AND NO STERILE LOT NUMBER INFORMATION HAS BEEN REPORTED, THUS, NO ANALYSIS OR DHR COULD BE PERFORMED. ANEURYSM RECANALIZATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE CODMAN EMBOLIC COIL DEVICE AND IS LISTED IN THE IFU. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT TARGET SITE CHARACTERISTICS, DISEASE PROCESS AND COIL PACKING DENSITY IN THE INDEX PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿PRELIMINARY EXPERIENCE OF CERECYTE COILS IN THE TREATMENT OF INTRACRANIAL ANEURYSMS¿ BY M. LEONARDI, M. DALL¿OLIO, O. ORTIZ VASQUEZ, C. QUERCETTI, PUBLISHED INTERVENTIONAL NEURORADIOLOGY 14: 285-292, 2008, THE AUTHORS REVIEW A COHORT IN A RETROSPECTIVE STUDY WERE CERECYTE COILS (MICRUS ENDOVASCULAR, SAN JOSE, CALIF) WERE THE ONLY BIOACTIVE COILS DEPLOYED OR CERECYTE COILS WERE USED IN THE FIRST EMBOLIZATION PROCEDURE FOR TREATMENT OF INTRACRANIAL ANEURYSM. THIRTY-NINE (39) PATIENTS MATCHED THESE INCLUSION CRITERIA, 15 MEN AND 24 WOMEN (AVERAGE AGE 63.5 YEARS) WITH 44 ANEURYSMS. SEVEN INTRACRANIAL STENTS WERE DEPLOYED: ¿ SIX NEUROFORM (BOSTON SCIENTIFIC); ¿ ONE LEO (BALT). CERECYTE COILS ALONE WERE DEPLOYED IN 15 ANEURYSMS. IN ALL, 21 PATIENTS WITH 24 UNRUPTURED ANEURYSMS WERE TREATED ELECTIVELY, WHEREAS 18 PATIENTS WITH 20 ANEURYSMS PRESENTED WITH SUBARACHNOID HEMORRHAGE CAUSED BY A RUPTURED ANEURYSM AND WERE TREATED IN AN EMERGENCY SETTING. TREATMENT OUTCOMES WERE: 30 ANEURYSMS COMPLETED EXCLUDED FROM THE CIRCULATION, 13 ANEURYSMS ALMOST COMPLETED EXCLUDED FROM THE CIRCULATION, ONE INCOMPLETE ANEURYSM OCCLUSION. TWO ANEURYSMS OUT OF 44 RECURRED DURING FOLLOW-UP (4.54%) AND WERE RE-EMBOLIZED. ONE WAS A LARGE ANEURYSM LOCATED ON THE LEFT VERTEBRAL ARTERY ABOVE THE ORIGIN OF THE POSTERO-INFERIOR CEREBELLAR ARTERY, THE OTHER WAS AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY. AFTER DIAGNOSTIC ANGIOGRAPHY, BOTH OF THESE ANEURYSMS WERE EMBOLIZED FOR A SECOND TIME USING CERECYTE AND GDC COILS. COMPLETE EXCLUSION OF THE ANEURYSMS WAS OBTAINED IN BOTH CASES AND CONFIRMED AT FOLLOW-UP MR ANGIOGRAPHY SIX MONTHS AFTER THE PROCEDURE FOR THE VERTEBRAL ARTERY LESION AND ONE MONTH AFTER FOR THE ANTERIOR COMMUNICATING ARTERY ANEURYSM. AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423007 UNKNOWN CERECYTE MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention