BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 6659426 · Received June 22, 2017

    Report

    Report Number
    2954740-2017-00180
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    January 6, 2017
    Report Date
    May 28, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: KRD/HCG. CONCOMITANT PRODUCT(S): TWO SL-10 MICROCATHETERS, TRAXCESS 14 MICROWIRE (MICROVENTION, (B)(4)), 6F SHUTTLE SHEATH (COOK, (B)(4)), AND TARGET DETACHABLE COILS (STRYKER NEUROVASCULAR) AND MICROPLEX 10 (MICROVENTION) 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 THIS MDR REPORT: 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. RESISTANCE BETWEEN THE MICROCATHETER AND THE COIL IS A KNOWN PROCEDURAL COMPLICATION. 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. FOR CASE 3, THE PATIENT WAS TREATED FOR AN UNRUPTURED ANEURYSM THAT WAS LOCATED AT THE RIGHT SUPERIOR HYPOPHYSEAL. TWO SL-10 MICROCATHETERS, TRAXCESS 14 MICROWIRE (MICROVENTION, (B)(4)), 6F SHUTTLE SHEATH (COOK, (B)(4)), AND TARGET DETACHABLE COILS (STRYKER NEUROVASCULAR) WERE USED ALONG WITH A DELTAPLUSH CERECYTE COIL (CATALOG AND LOT UNKNOWN) AND MICROPLEX 10 (MICROVENTION) COILS. FRICTION WAS NOTED IN THE NON-CODMAN MICROCATHETER DURING DELIVERY ATTEMPTS OF THE FILLING COILS (MICROPLEX 1.5/40, 1.5/30 MM, AND DELTAPLUSH CERECYTE 1.5/30 MM) AND 37 DAYS FOLLOWING TREATMENT, THE LESIONS WERE NOTED IN THE BRAIN. THE PATIENT WAS ASYMPTOMATIC AND NO TREATMENT WAS REQUIRED. THE AUTHORS CONCLUDED THE 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. THE ARTICLE DISCUSSED 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 DELAYED ENHANCING LESIONS (DEL) 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. 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
    441106 DELTAPLUSH - CERECYTE MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other