BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBIT GALAXY DETACHABLE COIL SYSTEM

    MDR report key: 6659432 · Received June 22, 2017

    Report

    Report Number
    3008264254-2017-00092
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    January 6, 2017
    Report Date
    May 28, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PROCODE: KRD/HCG. CONCOMITANT PRODUCT(S): TWO SL-10 MICROCATHETER, TAXCESS 14 MICROWIRE, TARGET COILS. DATE OF EVENT, PRODUCT CODE, AND LOT NUMBER NOT AVAILABLE. UDI: UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT PART NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. ARTICLE ATTACHED TO MDR: OH, S.W., NA, Y.S., LEE, H.J. ET AL. (2016). DELAYED ENHANCING LESIONS AFTER COIL EMBOLIZATION OF ANEURYSMS: CLINICAL EXPERIENCE AND BENCHTOP ANALYSES. J NEUROINTERVENT SURG 2017;0:1¿5. DOI:10.1136/NEURINTSURG-2016-012833. CONCLUSION: THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBER WAS NOT AVAILABLE; THEREFORE, A DHR COULD NOT BE PERFORMED. THE POTENTIAL FOR A REACTION TO THE FOREIGN BODY IS ALWAYS PRESENT WHEN IMPLANTATION OF MEDICAL DEVICES IS PERFORMED. IT IS A ROUTINE PORTION OF THE PATIENT¿S ASSESSMENT, BY THE IMPLANTING PHYSICIAN OR OTHER HEALTH CARE PROFESSIONALS, IN THE FOLLOW UP EXAMINATIONS. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT THE CONCOMITANT MICROCATHETER MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE (OH, S.W., NA, Y.S., LEE, H.J. ET AL. (2016). DELAYED ENHANCING LESIONS AFTER COIL EMBOLIZATION OF ANEURYSMS: CLINICAL EXPERIENCE AND BENCHTOP ANALYSES. J NEUROINTERVENT SURG 2017;0:1¿5. DOI:10.1136/NEURINTSURG-2016-012833), THE AUTHORS REPORT THEIR EXPERIENCES OF CAUSE OF DELAYED ENHANCING LESIONS COMPLICATION IN PATIENTS TREATED FOR CEREBRAL ANEURYSMS AND TO INVESTIGATE THE CAUSE OF THE LESIONS BY BENCHTOP ANALYSES. IN CASE# 1, THE PATIENT WAS TREATED FOR AN UNRUPTURED ANEURYSM THAT WAS LOCATED AT THE RIGHT OPHTHALMIC ARTERY. DELIVERY OF THE SUBSEQUENT FILLING COILS WAS ATTEMPTED WITH MULTIPLE COILS (TARGET 360 SOFT 8/200, 7/200, AND 6/150 MM) BUT FAILED OWING TO THE FRICTION. THE COILS AND THE MICROCATHETER WERE DISCARDED. AN ORBIT GALAXY (CODMAN) COIL WAS ADDITIONALLY USED IN CASE 1. THE ANGIOGRAPHIC COIL EMBOLIZATION WAS NEAR COMPLETE. DURING THE OUTPATIENT FOLLOW-UP, PATIENT PRESENTED WITH INTERMITTENT LEFT ARM WEAKNESS. PATIENT WAS TREATED WITH STEROIDS AND ANTICOAGULANT. THE SYMPTOMATIC PATIENT SHOWED GRADUAL IMPROVEMENT OF SYMPTOMS AFTER RECEIVING THE MEDICATION FOR 7 DAYS. BRAIN MR EVALUATIONS PERFORMED REVEALED MULTIPLE ENHANCING LESIONS IN THE HEMISPHERE 27 DAYS AFTER THE PROCEDURE. THE AUTHORS CONCLUDED BRAIN LESIONS WERE CAUSED BY FRAGMENTATION AND EMBOLI OF THE INNER COATING WALL OF THE MICROCATHETER. DEVELOPMENT OF UNUSUAL FRICTION DURING COIL DELIVERY MAY BE A SIGN OF DAMAGE OF THE MICROCATHETER INNER WALL AND THE DEVICE SHOULD BE DISCARDED. FROM A PROSPECTIVELY COLLECTED DATABASE CONSISTING OF 886 PATIENTS WITH ANEURYSMS TREATED ENDOVASCULARLY BETWEEN JANUARY 2010 AND DECEMBER 2015, THE ARTICLE DISCUSSED THREE PATIENTS WHO SHOWED DELS ON FOLLOW-UP CT/MR AFTER COIL EMBOLIZATION WERE SELECTED. DOUBLE MICROCATHETER TECHNIQUE WAS USED IN ALL CASES. STEAM SHAPING OF THE MICROCATHETER TIP WAS PERFORMED AT THE DISCRETION OF THE OPERATOR. THE INTERVAL FROM EVT TO INITIAL LESION DETECTION ON CT OR MR WAS 32.7 DAYS (RANGE 27¿37 DAYS). THE LESIONS MEASURED 3.0±1.4 MM (RANGE 0.8¿8.3 MM) IN SIZE. THE NUMBERS OF LESIONS WERE 3, 30, AND 107, RESPECTIVELY. THE LESIONS SHOWED SOLID ENHANCEMENT WITHOUT EVIDENCE OF NECROSIS, AND SURROUNDING T2 HYPERINTENSITY WITHOUT DIFFUSION RESTRICTION, SUGGESTING VASOGENIC EDEMA. THE LOT AND CATALOG NUMBERS OF THE CODMAN COILS WERE NOT PROVIDED IN THE ARTICLES. NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE AUTHOR, INCLUDING THE CATALOG AND LOT NUMBERS OF THE CODMAN COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441111 ORBIT GALAXY DETACHABLE COIL SYSTEM NEUROVASCULAR EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R