BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 3288330 · Received August 14, 2013

    Report

    Report Number
    1226348-2013-20154
    Event Type
    Malfunction
    Date Received
    August 14, 2013
    Date of Event
    July 22, 2013
    Report Date
    July 23, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING USE THE "REVIVE THROMBECTOMY DEVICE, SELF-EXPANDING" (FRS21452299 / C12288) THE DELIVERY WIRE SEPARATED IN PATIENT. DURING THROMBECTOMY IN THE RIGHT ARTERIA CEREBRI MEDIA, THE PUSHER WIRE BROKE AND THE MICROCATHETER (REBAR 18) HAD TO BE REMOVED TOGETHER WITH THE DEVICE. THE REVIVE SE IS WITHIN THE MICROCATHETER AND WILL BE RETURNED IN THIS WAY. IT IS THE FIRST GENERATION OF THE REVIVE. THE PATIENT HAD VERY CURVED VESSELS. A REBAR 18 MICROCATHETER WAS USED FOR THE PROCEDURE. NEITHER THE COMPLAINT DEVICE NOR THE CONCOMITANT DEVICE KINK/BENT PRIOR TO THE REPORTED EVENT. THE BROKEN PUSHER WIRE WAS THE ONLY DAMAGED NOTED WHEN THE DEVICE WAS REMOVED FROM THE DEVICE. AN ADEQUATE FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE. THERE WAS RESISTANCE WHEN THE DEVICE WAS ADVANCED SECONDARY TO TORTUOUS VESSELS. THERE IS NO OTHER INFORMATION AVAILABLE. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. THE BASKET WAS RETURNED UNDAMAGED WITH NO MATERIAL DEFECTS OR FABRICATION ISSUES. THE BASKET EXPANDED AS DESIGNED. THE SEVERED ENDS FRACTURE IS DUCTILE IN NATURE WHICH REQUIRED EXTERNAL FORCE. THE LOCATION OF THE SEVERED END DEEP INSIDE THE MICROPCATHETER¿S HUB SHOWS THAT THE EXTERNAL FORCE THAT WAS USED MAY HAVE BEEN PARTLY MECHANICAL IN NATURE WITH THE USE OF A STRAIGHT EDGE TOOL OF UNKNOWN ORIGIN. THE FIRST SEVERAL MILLIMETERS OF THE SEVERED END SHOWS A RADIUS THAT WAS DUE TO EXTERNAL FORCE WITH PRESSURE DIRECTLY AT THE FRACTURE SITE. THE SECTION OF METAL THAT HAS BEEN COMPRESSED AND LEFT A MARK ON SOME OF THE PHOTOS MOST LIKELY OCCURRED DURING THE RETRACTION OF THE REVIVE OUT OF THE MICROCATHETER. NO MATERIAL DEFECTS WERE FOUND TO THE SEVERED END OF THE CORE WIRE. THE RETURNED REBAR 18 MICROCATHETER PASSED INSPECTION AND FUNCTIONALITY TESTING. NO ANOMALIES TO THE INNER DIAMETER WERE FOUND. A NEW TEST REVIVE WAS ADVANCED THROUGH AND OUT THE DISTAL TIP OF THE RETURNED MICROCATHETER WITH NO SIGNIFICANT RESISTANCE ENCOUNTERED. THEREFORE, THE REBAR 18 MICROCATHETER, BY ITSELF, DID NOT CONTRIBUTE TO THE FIELD COMPLAINT. THE MOST LIKELY PRIMARY CONTRIBUTING FACTOR TO THE CORE WIRE BEING SEVERED WAS DUE TO EXTERNAL FORCE WITH THE POSSIBLE APPLICATION OF A STRAIGHT EDGE TOOL OF UNKNOWN ORIGIN PRODUCING MECHANICAL DAMAGE AT THE SEVERED END. IN ADDITION, WITHOUT THE RETURN OF THE SEVERED 45.0 CENTIMETERS OF THE PROXIMAL SECTION OF THE REVIVE USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS SEVERED COMPONENT HAD ANY ADDITIONAL CONTRIBUTIONS TO THE COMPLAINT EVENT. A SECONDARY CONTRIBUTING FACTOR MAY HAVE BEEN DUE TO DISTAL INTERFERENCE INSIDE THE MICROCATHETER AND/OR THE ¿CURVY¿ VESSEL TORTUOSITY REPORTED IN THE EVENT DESCRIPTION. THE DISTAL TIP SECTION OF THE BASKET WAS RETURNED WITH A ARC WHICH STRAIGHTENED AFTER CLEANING. THIS SHOWS THE POSSIBLY OF INTERFERENCE EXISTING INSIDE THE MICROCATHETER. WHILE THE BLOOD MIXTURE FOUND ADHERING TO THE BASKET HAD PROTEIN IN THE BLOOD, CONTRAST, AND PROTEIN MIXTURE, IT CANNOT BE DETERMINED IF THE ADDITIONAL PRESENCE OF PROTEIN PRODUCED INTERFERENCE. THEREFORE, THE SOURCE OF POSSIBLE INTERFERENCE; WHETHER OF A FIXED OR DETACHED NATURE CANNOT BE DETERMINED. 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. THE SEPARATION COMPLAINT WAS CONFIRMED; HOWEVER THE ROOT CAUSE COULD NOT BE DETERMINED. 100% INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE CONFIRMED EVENT.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED STATES THAT DURING USE THE "REVIVE THROMBECTOMY DEVICE, SELF-EXPANDING" (FRS21452299 / C12288) THE DELIVERY WIRE SEPARATED IN PATIENT. DURING THROMBECTOMY IN THE RIGHT ARTERIA CEREBRI MEDIA, THE PUSHER WIRE BROKE AND THE MICROCATHETER (REBAR 18) HAD TO BE REMOVED TOGETHER WITH THE DEVICE. THE REVIVE SE IS WITHIN THE MICROCATHETER AND WILL BE RETURNED IN THIS WAY. IT IS THE FIRST GENERATION OF THE REVIVE. THE PATIENT HAD VERY CURVED VESSELS. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. A REBAR 18 MICROCATHETER WAS USED FOR THE PROCEDURE. NEITHER THE COMPLAINT DEVICE NOR THE CONCOMITANT DEVICE KINK/BENT PRIOR TO THE REPORTED EVENT. THE BROKEN PUSHER WIRE WAS THE ONLY DAMAGED NOTED WHEN THE DEVICE WAS REMOVED FROM THE DEVICE. AN ADEQUATE FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE. THERE WAS RESISTANCE WHEN THE DEVICE WAS ADVANCED SECONDARY TO TORTUOUS VESSELS. THIS IS (B)(6) FEMALE. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391536 REVIVE - THROMBECTOMY DEVICE MICRUS THROMBECTOMY HCG MICRUS ENDOVASCULAR, LLC NA C12288

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR UNK REBAR 18