BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EU ENT4.5MMD 22MML WNO DSTL TP

    MDR report key: 19272131 · Received May 8, 2024

    Report

    Report Number
    3008114965-2024-00464
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 29, 2024
    Report Date
    May 8, 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 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 8697616. 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 IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2024-00464 AND 3008114965-2024-00465. 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 4.5MM X 22MM NO DISTAL TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE ((B)(6)) WAS IMPEDED IN THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER ((B)(6)) AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT AND SWITCH TO A NEW STENT TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 07-MAY-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE INTENDED PROCEDURE WAS A STENT-ASSISTED ANEURYSM EMBOLIZATION THAT TARGETED THE INTERNAL CAROTID ARTERY (ICA). THE TARGET WAS AN UNRUPTURED ANEURYSM LOCATED ON THE OPHTHALMIC SEGMENT OF THE ICA. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NOTHING UNUSUAL WAS NOTED ABOUT THE SYSTEM PRIOR TO USE. THE REPLACEMENT STENT WAS ANOTHER 4.5MM X 22MM NO DISTAL TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE ((B)(6)); ANOTHER PROWLER SELECT PLUS MICROCATHETER ((B)(6)) WAS USED WITH THE REPLACEMENT STENT. THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT AND THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100045 EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 8697616

    Patients

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