BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CERECYTE MICROCOIL

    MDR report key: 6647689 · Received June 16, 2017

    Report

    Report Number
    2954740-2017-00143
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Date of Event
    January 1, 2009
    Report Date
    May 23, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PROCODE: KRD/HCG. CONCOMITANT MEDICAL PRODUCTS: 30 MM X 4.5 MM NEUROFORM 3 STENT (BOSTON SCIENTIFIC/TARGET, (B)(4)). UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT PART NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. DATE OF EVENT, PRODUCT CODE, AND LOT NUMBER NOT AVAILABLE. THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR WERE UNSUCCESSFUL. THIS IS AN INITIAL/FINAL MDR REPORT. CONCLUSION: THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DHR COULD NOT BE PERFORMED. PROTRUSION OF THE COIL OUT OF THE ANEURYSM IS A KNOWN PROCEDURAL COMPLICATION ASSOCIATED WITH COIL EMBOLIZATION PROCEDURES. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, ANEURYSM CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. COIL PROTRUSION FROM THE ANEURYSM IS MORE COMMON WITH WIDE NECK ANEURYSMS AND THE STENT IS INTENDED TO HELP MAINTAIN THE COIL WITHIN THE ANEURYSM. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿COIL MIGRATION THROUGH A NEUROFORM 3 STENT DURING ENDOVASCULAR COILING¿ BY A. O¿HARE, J.THORNTON, P. BRENNAN, PUBLISHED INTERVENTIONAL NEURORADIOLOGY 15: 219-222, 2009, THE AUTHORS PRESENT A CASE WHERE A CODMAN CERECYTE COIL (CATALOG AND LOT UNKNOWN) PROTRUDED INTO THE PARENT ARTERY THROUGH A NON-CODMAN STENT. A (B)(6) WOMAN PRESENTED AFTER AN INCIDENTAL FINDING OF THREE CEREBRAL ANEURYSMS. THE TWO RIGHT CAROTID ANEURYSMS WERE SUCCESSFULLY COILED ON TWO SEPARATE OCCASIONS. A LEFT PERIOPHTHALMIC ANEURYSM WAS TOO BROAD-NECKED TO COIL UNASSISTED AND THEREFORE A 30 MM X 4.5 MM NEUROFORM 3 STENT (BOSTON SCIENTIFIC/TARGET, (B)(4)) WAS PLACED ACROSS THE ANEURYSM NECK. THE PROCEDURE WAS UNCOMPLICATED WITH THE PLATINUM STRUTS IN A SATISFACTORY POSITION, AND THE PATIENT RETURNED HOME ON DUAL ANTIPLATELET THERAPY TO RETURN IN SIX WEEKS FOR ENDOVASCULAR COILING OF THIS ANEURYSM. SIX WEEKS LATER, ANGIOGRAPHY SHOWED THAT THE ANEURYSM WAS UNCHANGED AND MEASURED 4 X 2.5 MM. THE STENT REMAINED IN ITS CORRECT POSITION AND A 0.17 COURIER CATHETER WAS ADVANCED OVER A TRANSCEND WIRE TO THE ANEURYSM. THE CATHETER WAS SUCCESSFULLY PLACED IN THE ANEURYSM AFTER SEVERAL ATTEMPTS. THE INITIAL COIL WAS ADVANCED (CERECYTE 2.5 X 3.3 CM). DESPITE THE OPTIMAL WORKING ANGLE, DIFFICULTY AROSE IN ASCERTAINING WHETHER THIS FIRST COIL WAS COMPLETELY INSIDE THE ANEURYSM OR WHETHER SOME OF THE LOOPS PROTRUDED INTO THE PARENT VESSEL. A LOW CONTRAST DYNACT (SIEMENS MEDICAL SOLUTIONS, FORCHEIM, GERMANY) WAS UNABLE TO IDENTIFY THE STRUTS OF THE STENT. THE CT DID SHOW PROBABLE COIL HERNIATION THROUGH THE STENT INTO THE CAROTID AND THE COIL WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED ABOUT THE CODMAN CERECYTE COIL, INCLUDING CATALOG AND LOT NUMBER OR DATE OF PROCEDURE. THE MICROCATHETER WAS REPOSITIONED AND ANOTHER COIL (HYDROCOIL, 2 X 4CM, MICROVENTION, ALISO VIEJO, CA, USA) PLACED WHICH HAD A MORE FAVOURABLE APPEARANCE. THIS WAS DEPLOYED AND FOLLOWED BY A SECOND COIL (HYDROCOIL, 2 X 3CM) AT THE SAME CATHETER POSITION. AS THE SECOND COIL NEARED THE POINT OF DETACHMENT THE FIRST COIL HERNIATED IN ITS ENTIRETY INTO THE PARENT VESSEL. THE SECOND COIL WAS RETRACTED AND THE HERNIATED COIL DRIFTED TOWARD THE MIDDLE CEREBRAL ARTERY (MCA). ATTEMPTS WERE MADE TO RETRIEVE THE COIL USING THE MERCI DEVICE (CONCENTRIC MEDICAL, INC, (B)(4)). ALTHOUGH SUCCESSFUL ON GAINING PURCHASE ON THE HERNIATED COIL, ON WITHDRAWING THE DEVICE IT CONSISTENTLY FAILED TO ENTER THE DISTAL END OF THE STENT AT THE LEVEL OF THE DISTAL MARKERS. THE COIL HERNIATED FURTHER UP THE MCA. NO MORE RETRIEVAL EFFORTS WERE MADE AND 4 MG ATEPLASE WAS ADMINISTERED LOCALLY THROUGH THE MICROCATHETER TO IMPROVE THE COMPROMISED FLOW IN THE MCA. THE PATIENT REMAINED ON HEPARIN. ON POST-OPERATIVE NEUROLOGICAL ASSESSMENT, THE ONLY DEFICIT WAS SOME SUBTLE DECREASE IN THE EXTENSORS OF THE RIGHT HAND. NO FURTHER INFORMATION COULD BE OBTAINED ABOUT THE CODMAN CERECYTE COIL, INCLUDING CATALOG AND LOT NUMBER OR DATE OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429017 UNKNOWN CERECYTE MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR