BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CERECYTE MICROCOIL

    MDR report key: 4461522 · Received January 28, 2015

    Report

    Report Number
    2954740-2015-00038
    Event Type
    Injury
    Date Received
    January 28, 2015
    Date of Event
    July 1, 2013
    Report Date
    January 14, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT AVAILABLE FOR ANALYSIS. NO STERILE LOT NUMBER WAS REPORTED THUS NO DHR COULD BE CONDUCTED. ALTHOUGH ASEPTIC INFLAMMATION IS NOT SPECIFICALLY LISTED IN THE PRODUCT LABELING AS A POTENTIAL ADVERSE EVENTS ASSOCIATED WITH USE OF THE DEVICES, THE SYMPTOMS REPORTED ARE NEUROLOGIC CHANGES. PER THE MICROCOIL IFU POSSIBLE ADVERSE EVENTS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: HEMATOMA AT SITE OF ENTRY, VESSEL PERFORATION, INFECTION, EMBOLI, HEMORRHAGE, ISCHEMIA OR VASOSPASM, NEUROLOGICAL DEFICITS INCLUDING STROKE, AND POSSIBLY DEATH. ALL PRODUCTS ARE 100% INSPECTED PRIOR TO LEAVING THE MANUFACTURING FACILITY AND THERE IS NO EVIDENCE OF A MANUFACTURING RELATED ISSUE. REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT PATIENT PHYSIOLOGIC FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: GDC ULTRASOFT (BOSTON SCIENTIFIC, LOT UNKNOWN)/ MATRIX 2 COIL (BOSTON SCIENTIFIC, LOT UNKNOWN)/ THE PRODUCT IS IMPLANTED AND WILL NOT BE RETURNED. CONCLUSIONS ON THE EVENT ARE BEING FORMULATED AND ARE FORTHCOMING.

    Description of Event or Problem · 1

    REVIEW OF A LITERATURE ARTICLE JAWID, MADJIDYAR; ULRIKE, BRANDT; ANDREAS, BINDER; OLAV, JANSEN, NEURORADIOLOGY (2014) 56: 1129-1132, ¿LATE OCCURRENCE OF A SYMPTOMATIC PERIANEURYSMAL EDEMA AND WALL ENHANCEMENT AFTER COIL EMBOLIZATION¿ REVEALED THAT APPROXIMATELY EIGHT (8) YEARS POST COILING THE PATIENT PRESENTED WITH TRANSIENT RIGHT SIDED HEMIPARESIS, APHASIA AND DYSARTHRIA. IN (B)(6) 2005, A (B)(6) YEAR-OLD FEMALE PATIENT, UNDERWENT SUCCESSFUL COIL EMBOLIZATION OF THREE (3) INCIDENTAL ANEURYSMS. THE ANEURYSMS WERE LOCATED IN THE M2-SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA; 4X3X3 MM; NECK WIDTH, 1.6 MM), IN THE DISTAL LEFT INTERNAL CAROTID ARTERY (ICA; 6.8X3.4X3.3 MM; NECK WIDTH, 2.8MM), AND IN THE A-1 SEGMENT OF THE LEFT ANTERIOR CEREBRAL ARTERY (ACA; 5.1X4.6X4.6 MM; NECK WIDTH, 1.8MM). TWO TYPES OF COILS WERE USED; BARE PLATINUM COILS AND BIO-ACTIVE COILS. THE BARE PLATINUM AND ONE TYPE OF BIO-ACTIVE COILS WERE FROM COMPETITOR COMPANIES AND THE SECOND TYPE OF BIO-ACTIVE COILS USED WAS MICRUS CERECYTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY REPORT OF ISSUES, AND FOLLOW UP IMAGING WAS DONE WITHOUT REPORT OF ISSUES AT FOUR (4) DAYS, ONE (1) YEAR AND TWO (2) YEARS POST INDEX PROCEDURE. APPROXIMATELY EIGHT (8) YEARS POST INDEX, THE PATIENT PRESENTED WITH TRANSIENT RIGHT SIDED HEMIPARESIS, APHASIA AND DYSARTHRIA. DURING HOSPITALIZATION FURTHER EPISODES WERE WITNESSED. MRI REVEALED PERIANEURYSMAL BRAIN EDEMA AND WALL ENHANCEMENT OF THE ANEURYSM IN THE LEFT ICA. THE OTHER TWO TREATED SITES HAD NO PATHOLOGIC FINDINGS. ALL ADDITIONAL LAB FINDINGS SUPPORTED THE DIAGNOSIS OF LATE ASEPTIC INFLAMMATORY REACTION SECONDARY TO FOREIGN BODY REACTION WHICH WAS TREATED WITH A COURSE OF CORTICOSTEROIDS. WITH THE TREATMENT THE HEMIPARESIS AND DYSARTHRIA DID NOT REAPPEAR; HOWEVER, TRANSIENT HEADACHE DID PERSIST. FOLLOW UP MRI AFTER ONE WEEK AND THREE WEEKS SHOWED PROGRESSIVE ALMOST COMPLETE RESOLUTION OF THE BRAIN EDEMA AND WALL ENHANCEMENT. UP TO 2 YEARS POST STEROID TREATMENT THERE WAS NO REOCCURRENCE OF THE EDEMA SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65370 UNKNOWN CERECYTE MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R