BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 23397891 · Received October 27, 2025

    Report

    Report Number
    3008114965-2025-01109
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 13, 2025
    Report Date
    October 30, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704075257
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    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). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 28-OCT-2025. [ADDITIONAL INFORMATION]: ON 28-OCT-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION IS A REVISION OF THE INITIAL/ORIGINAL EVENT DESCRIPTION. PER THE ADDITIONAL INFORMATION AS CONFIRMED WITH THE CERENOVUS SALES REPRESENTATIVE, ¿DURING THE PROCEDURE, [THE] STENT PASSED THE MICROCATHETER AND [WAS] RELEASED IN THE PATIENT. IT WAS FOUND THAT THE STENT WAS NOT IN THE DESIRED LOCATION, [THE] PHYSICIAN USED [ANOTHER] DEVICE TO CAPTURE THE STENT AND REMOVED IT FROM THE PATIENT, THEN RELEASED A NEW STENT IN THE TARGET SITE. THE MICROCATHETER WAS NOT REPLACED.¿ PER THE ADDITIONAL/MODIFIED INFORMATION RECEIVED ON 28-OCT-2025, THIS COMPLAINT WAS REASSESSED. IT WAS DISCLOSED THAT THE STENT DID NOT PREMATURELY DETACH BUT WAS DETACHED AT AN UNDESIRABLE LOCATION. THE PHYSICIAN REMOVED THE STENT (PRESUMABLY WITH THE MICROCATHETER) AND RELEASED A NEW STENT AT THE TARGET SITE. SINCE NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED, THIS EVENT NO LONGER MEETS US FDA REPORTING CRITERIA AS A ¿SERIOUS INJURY.¿ THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. UPDATED SECTIONS: B.4, G.3, G.6, H.1, H.2, H.6, AND H.11. 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). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: INITIAL REPORTER FACILITY NAME: (B)(6). BASED ON COMPLAINT INFORMATION, THE DEVICE REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. THE PROCEDURE IMAGE INCLUDED IN THE COMPLAINT WAS REVIEWED BY THE SENIOR MEDICAL AFFAIRS DIRECTOR. THE REVIEW IS DOCUMENTED BELOW. [PROCEDURE IMAGE REVIEW]: THE CASE INCLUDES A SINGLE UN-SUBTRACTED NON-CONTRAST FLUOROSCOPIC IMAGE SHOWING A PARTIALLY COILED ANEURYSM AND TWO STENT MARKERS, ONE CLEARLY POSITIONED DISTAL TO THE ANEURYSM. BASED ON THE IMAGE AND DESCRIPTION, THE CAUSE OF PREMATURE DETACHMENT CANNOT BE DETERMINED. DISTAL STENT LOSS TYPICALLY RESULTS FROM PARTIAL DEPLOYMENT FOLLOWED BY MICROCATHETER RETRIEVAL, WHICH REMOVES SLACK AND EXPOSES THE STENT BEYOND THE NON-RETRIEVABLE SEGMENT. PHYSICIAN NAME AND DATE REVIEWED: (B)(6) MD, MSC, ON (B)(6) 2025. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT: 9080736. 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 LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND / OR DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. PREMATURE DETACHMENT IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE ENTERPRISE2 VASCULAR RECONSTRUCTION DEVICE. IF THE STENT WAS PREMATURELY DEPLOYED IN THE PATIENT (IN AN UNINTENDED SITE), IT MAY LEAD TO DAMAGE OF HEALTHY INTIMA, POSSIBLE SIDE BRANCH OCCLUSION, ISCHEMIA, INFARCT AND/OR THE NEED FOR ADDITIONAL INTERVENTION. THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING VESSEL CHARACTERISTICS, DEVICE INTERACTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THIS CASE, THERE WAS NO REPORT OF PATIENT INJURY; HOWEVER, THE USER WAS REQUIRED TO PERFORM THE ADDITIONAL SURGICAL INTERVENTION OF IMPLANTING A SECOND STENT TO COVER THE FULL NECK OF THE ANEURYSM. BASED ON THIS SURGICAL INTERVENTION, THIS EVENT MEETS US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED LATER. 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. 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 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENCR401612 / 9080736) JUST PASSED THE MICROCATHETER AND THE STENT WAS PREMATURELY RELEASED NOT COVERING THE ANEURYSM NECK. THE PHYSICIAN IMPLANTED A SECOND STENT TO COVER THE ANEURYSM NECK AND COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A SINGULAR PROCEDURE IMAGE WAS INCLUDED. THE IMAGE WILL UNDERGO INDEPENDENT PHYSICIAN REVIEW. ADDITIONAL INFORMATION WAS RECEIVED ON 22-OCT-2025. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING AN UNRUPTURED REGULAR 4.2MM X 4.5MM ANEURYSM ON THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE HAD BEEN NO RESISTANCE DURING THE ADVANCEMENT OF THE STENT. PER THE INFORMATION, THE SECOND STENT WAS ANOTHER 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (ENCR401612). THE CONCOMITANT MICROCATHETER WAS A 150CM X 5CM PROWLER SELECT PLUS (606S255X / LOT#: UNKNOWN); THIS MICROCATHETER WAS USED TO DELIVER THE SECOND STENT. THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE IMPACT ON THE PATIENT AND NO CLINICALLY SIGNIFICANT DELAY DUE TO THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292881 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9080736 10886704075257

    Patients

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