BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EU 4.5X22MM STENT 12 MM DW TIP

    MDR report key: 20295423 · Received September 24, 2024

    Report

    Report Number
    3008114965-2024-00924
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    September 14, 2024
    Report Date
    September 24, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704043980
    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, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: THE INITIAL REPORTER PHONE: (B)(6). 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 8872359. 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 JOHNSON & JOHNSON MEDTECH, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, JOHNSON & JOHNSON MEDTECH, 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 ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212 / 8872359) PASSED THROUGH THE TIP OF THE MICROCATHETER (UNSPECIFIED BRAND) AND THE PHYSICIAN TRIED TO RELEASE THE STENT. IT WAS OBSERVED THAT THE DISTAL MARKERS OF THE STENT FULLY OPENED BUT THE MIDDLE SECTION OF THE STENT COULD NOT FULLY OPEN OR EXPAND AS INTENDED, CAUSING THE INABILITY TO COVER THE ANEURYSM NECK WELL, AND PART OF THE COIL (COMPETITOR BRAND) PROTRUDED OUT OF THE ANEURYSM. THE PHYSICIAN RETRACTED THE STENT AND DELIVERED THE STENT AGAIN AND STARTED TO RELEASE IT AGAIN, BUT THE STENT MIDDLE SECTION STILL WAS UNABLE TO OPEN COMPLETELY. THE PHYSICIAN RETRACTED THE STENT AND REPLACED IT WITH A NEW STENT TO COMPLETE THE PROCEDURE USING THE ORIGINAL CONCOMITANT MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT BUT THE PROCEDURE WAS REPORTEDLY PROLONGED BY APPROXIMATELY 20 MINUTES. ON 23-SEP-2024, IT WAS REPORTED THAT ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE ARE NOT AVAILABLE / CANNOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104334 EU 4.5X22MM STENT 12 MM DW TIP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 8872359 10886704043980

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown EMBOLIC COILS (UNSPECIFIED BRAND)| MICROCATHETER (UNSPECIFIED BRAND)