BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX23MM

    MDR report key: 18555878 · Received January 22, 2024

    Report

    Report Number
    3008114965-2024-00105
    Event Type
    Malfunction
    Date Received
    January 22, 2024
    Date of Event
    December 28, 2023
    Report Date
    January 22, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS WAS NOT AVAILABLE / REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 8130016. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE COMPLAINT PRODUCT AVAILABLE TO BE RETURNED FOR ANALYSIS, THE REPORTED PRODUCT ISSUE DOCUMENTED IN THE COMPLAINT CANNOT BE CONFIRMED THROUGH FUNCTIONAL EVALUATION AND ANALYSIS. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4MM X 23MM ENTERPRISE 2 STENT (ENCR402312 / 8130016) WAS IMPEDED IN THE DISTAL END OF THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND SWITCH TO NEW DEVICES (COMPETITOR BRANDS) TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 02-JAN-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET VESSEL WAS THE MIDDLE CEREBRAL ARTERY (MCA) THERE WAS NO REMARKABLE ANATOMICAL FEATURE NOTED ¿ I.E., NO CALCIFICATION / TORTUOSITY. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV) DURING THE DEVICE ADVANCEMENT. EXCESSIVE FORCE WAS NOT EXERTED ON TO THE DEVICE. THE INFORMATION CONFIRMED THE COMPLAINT DEVICE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052909 ENTERPRISE2 4MMX23MM INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 8130016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MICROCATHTER (UNSPECIFIED BRAND)