BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX16MM NO TIP

    MDR report key: 16087929 · Received January 3, 2023

    Report

    Report Number
    3008114965-2022-00857
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    December 16, 2022
    Report Date
    January 9, 2023
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. INITIAL REPORTER FACILITY NAME: (B)(6). THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS WAS NOT AVAILABLE / REPORTED. CONCLUSION: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT STENT, A 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENCR401600 / 7121771) WAS DELIVERED INTO A CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) AND PLACED IN THE TARGET LESION. WHEN APPROXIMATELY 50% OF THE STENT WAS RELEASED, THE PHYSICIAN OBSERVED THAT THE POSITION WAS NOT ACCURATE AND ATTEMPTED TO RETRACT THE STENT FOR ADJUSTMENT. THE STENT WAS IMPEDED IN THE MICROCATHETER AND COULD NOT BE ADVANCED NOR WITHDRAWN. THE PHYSICIAN RETRACTED THE DEVICES AND REPLACED THE STENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. BASED ON COMPLAINT INFORMATION, THE DEVICE IS 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 7121771. 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 ISSUE IN THE COMPLAINT CANNOT BE CONFIRMED. 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 SAMPLE; 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 09-JAN-2023. [ADDITIONAL INFORMATION]: ON 09-JAN-2023, THE CERENOVUS SALES REPRESENTATIVE, PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE TARGETING AN ANEURYSM ON THE ANTERIOR CEREBRAL ARTERY (ACA). THE MICROCATHETER USED DURING THE PROCEDURE WITH THE 4MM X 16MM ENTERPRISE 2 VRD WAS A PROWLER SELECT PLUS (CATALOG/LOT# UNKNOWN). A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE STENT / STENT DELIVERY SYSTEM DID NOT APPEAR DAMAGED. WHEN THE STENT WAS REMOVED FROM THE PATIENT, IT WAS STILL ON THE DELIVERY WIRE. NOTHING UNUSUAL WAS NOTED ABOUT THE SYSTEM PRIOR TO USE. THE REPLACEMENT STENT WAS NOT ANOTHER 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENCR401600). THE REPLACEMENT MICROCATHETER WAS A REBAR¿ 18 MICROCATHETER (MEDTRONIC). THE REPORTED ISSUE DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. UPDATED SECTIONS: B.4, G.3, G.6, H.2, H.10, AND CONCOMITANT PRODUCTS. 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 COMPLAINT STENT, A 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENCR401600 / 7121771) WAS DELIVERED INTO A CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) AND PLACED IN THE TARGET LESION. WHEN APPROXIMATELY 50% OF THE STENT WAS RELEASED, THE PHYSICIAN OBSERVED THAT THE POSITION WAS NOT ACCURATE AND ATTEMPTED TO RETRACT THE STENT FOR ADJUSTMENT. THE STENT WAS IMPEDED IN THE MICROCATHETER AND COULD NOT BE ADVANCED NOR WITHDRAWN. THE PHYSICIAN RETRACTED THE DEVICES AND REPLACED THE STENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508141 ENTERPRISE2 4MMX16MM NO TIP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 7121771

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MICROCATHETER