BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTAXTRASOFT COIL

    MDR report key: 5153585 · Received October 15, 2015

    Report

    Report Number
    1226348-2015-00053
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    September 18, 2015
    Report Date
    September 18, 2015
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K150319
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELTAXSFT (DLX100204, LOT C36672) WILL NOT BE RETURNED, THEREFORE THE ROOT CAUSE OF THE DEPLOYMENT DIFFICULTY CANNOT BE DETERMINED. DHR: A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. BASED ON THE INFORMATION, THE ISSUE WITH THIS DEVICE COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER, A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. UDI: (B)(4). THIS REPORT IS RELATED TO MFR. REPORT # 1226348-2015-00052.

    Description of Event or Problem · 1

    THE CONTACT AT THE FACILITY REPORTED THAT DURING EMBOLIZATION OF A PERI-OPHTHALMIC INTERNAL CAROTID ARTERY ANEURYSM THERE WAS RESISTANCE ADVANCING TWO DELTAXSOFT COILS (BOTH DLX100206/C36656) AND A DELTAXSOFT COIL (DLX100204/C36655) BECAME ENTANGLED WITH ANOTHER DELTAXSOFT COIL (DLX100204/C36672) AT THE DISTAL TIP OF THE MICROCATHETER. THE ANEURYSM SACCULAR AND WAS NOT WIDE NECK, APPROXIMATELY 3.9 X 4.1 MM IN DIAMETER. THE PATIENT'S VESSELS WERE NOT CALCIFIED. THERE WAS TORTUOSITY PROXIMAL TO THE PARENT VESSEL DUE TO THE CAROTID SIPHON; HOWEVER, NO OTHER TORTUOSITY REPORTED. THERE WERE FIVE COILS DEPLOYED IN THE ANEURYSM. HOWEVER, THERE WERE A TOTAL OF 8 COILS OPENED FOR THE CASE. THE FIRST FOUR COILS INCLUDING 2 MICRUSFRAME (MFR100412/C36806 AND MFR100305/C36803) AND 2 DELTAXSOFT (BOTH DLX100206/C36656) WERE DEPLOYED SUCCESSFULLY WITH NO REPORTED ISSUE. THEN THE PHYSICIAN FELT RESISTANCE APPROXIMATELY 1/3 OF THE WAY FROM THE PROXIMAL END OF THE PROWLER SELECT LP-ES 45 DEGREE TIP MICROCATHETER (DETAILS UNKNOWN) WHEN ADVANCING TWO DELTAXSOFT COILS (BOTH DLX100206/C36656.) THE RESISTANCE OCCURRED WITH BOTH COILS IN THE SHAFT OF THE MICROCATHETER AS THE FLUOROSAVER MARKERS WERE ADVANCED TO THE ENTRY POINT OF SHEATH IN THE VICINITY OF THE GREEN RESHEATHING TOOL. THERE WAS NO RESISTANCE WITH THE GUIDEWIRE WHEN THE MICROCATHETER WAS ADVANCED TO THE TARGET SITE. BOTH COILS WERE REMOVED WITH THE MICROCATHETER REMAINING IN PLACE. BOTH COILS WERE AVAILABLE TO BE RETURNED FOR ANALYSIS. NEXT, A DELTAXSOFT COIL (DLX100204/C36672) WAS ADVANCED AND DETACHED SUCCESSFULLY. THEN ANOTHER DELTAXSOFT COIL (DLX100204/C36655) WAS ADVANCED IN THE MICROCATHETER BUT WOULD NOT ADVANCE BEYOND THE TIP OF THE MICROCATHETER. AS THE PHYSICIAN ATTEMPTED TO RETRACT THE COIL, THE MICROCATHETER AND THE PREVIOUS DELTAXSOFT COIL (DLX100204/C36672) BEGAN TO PULL OUT OF THE ANEURYSM. THE PROXIMAL TAIL OF THE PREVIOUS COIL (LOT 36672) WAS STILL INSIDE THE MICROCATHETER TIP, AND THE COIL (LOT C36655) HAD WEDGED ALONGSIDE OF IT, LOCKING THE DISTAL TIP OF THE COIL THE PROXIMAL END OF PREVIOUS COIL. BOTH WERE STUCK AT THAT POINT IN THE MICROCATHETER AT THE DISTAL TIP. THE MICROCATHETER WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER. THE PROXIMAL END OF THE COIL WAS IN THE MICROCATHETER AS A RESULT OF THE DETACHMENT ZONE OF THE COIL BEING WITHDRAWN SLIGHTLY INTO THE TIP OF THE MICROCATHETER PRIOR TO DETACHMENT. THE PHYSICIAN PULLED THE MICROCATHETER, AND EVENTUALLY THE TWO COILS BROKE FREE OF EACH OTHER, BUT ONLY AFTER LEAVING A COUPLE OF PROXIMAL LOOPS OF THE PREVIOUS COIL (LOT C36672) IN THE PARENT VESSEL. THE PHYSICIAN THEN CHOSE TO STENT THE EXPOSED COIL TO THE PARENT VESSEL WITH A 4.5 X 22 MM ENTERPRISE STENT NO TIP (DETAILS UNKNOWN.) THE STENT WAS DEPLOYED SUCCESSFULLY AND THE EXPOSED PORTION OF EMBOLIC COIL WAS PINNED TO THE WALL OF THE PARENT VESSEL. THERE WAS SIGNIFICANT DELAY WHEN LOT C36672 WAS PINNED TO THE WALL; HOWEVER, THE PATIENT ENCOUNTERED NO OTHER ISSUES AS A RESULT OF THE PROCEDURE AND DID NOT SUFFER ANY INJURY DUE TO THE PROCEDURE. THERE WAS NO STRETCHING NOTED TO THE TWO COILS. THE DELTAXSOFT COIL (DLX100204/C36655) WAS AVAILABLE FOR RETURN WITHIN THE PROWLER SELECT LP ES MICROCATHETER. THE MICROCATHETER WAS DROPPED ON THE FLOOR WITH THE COIL IN IT PRIOR TO BEING RETRIEVED FOR RETURN. NONE OF THE DEVICES WERE KINKED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684647 DELTAXTRASOFT COIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL C36672

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention