BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX23MM

    MDR report key: 16644545 · Received March 30, 2023

    Report

    Report Number
    3008114965-2023-00176
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 19, 2023
    Report Date
    March 30, 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, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. THE INITIAL REPORTER NAME AND ADDRESS: (B)(6). BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. (B)(6) MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 6970733. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(6) 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.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WAS SUFFERING FROM AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM UNDERWENT A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION. AFTER THE 4MM X 23MM ENTERPRISE 2 STENT (ENCR402312 / 6970733) WAS PLACED IN THE TARGET POSITION, THE STENT BECAME IMPEDED IN THE MICROCATHETER TIP AND COULD NOT PASS THROUGH IT. THE PHYSICIAN RETRACTED THE STENT WITH THE MICROCATHETER TOGETHER AND REPLACED THE STENT TO COMPLETE THE PROCEDURE; THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS. ON 29-MAR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT WHEN THE STENT WAS REMOVED FROM THE PATIENT, IT WAS STILL ON THE DELIVERY WIRE. THE STENT / STENT DELIVERY SYSTEM DID NOT APPEAR DAMAGED. NOTHING UNUSUAL WAS NOTED ABOUT THE SYSTEM PRIOR TO USE. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER DURING THE PROCEDURE; THE MICROCATHETER USED WAS A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 30743228). THERE WERE NO VISIBLE KINKS OR OTHER DAMAGES OBSERVED ON THE MICROCATHETER. THE REPLACEMENT STENT WAS ANOTHER 4MM X 23MM ENTERPRISE 2 STENT (ENCR402312). THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241407 ENTERPRISE2 4MMX23MM INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 6970733

    Patients

    Seq Age Sex Outcome Treatment
    1 Male PROWLER SELECT PLUS 150/5CM