BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENOVUS ENTERPRISE

    MDR report key: 21961242 · Received May 5, 2025

    Report

    Report Number
    3008114965-2025-00384
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    April 25, 2025
    Report Date
    May 5, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704075288
    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. (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 IS NOT AVAILABLE / REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 9242471. 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. THE INCOMPLETE EXPANSION OF THE ENTERPRISE2 VASCULAR RECONSTRUCTION DEVICE (VDR) CAN POTENTIALLY LEAD TO THROMBOSIS AND/OR MIGRATION OR EMBOLIZATION, RESULTING IN ISCHEMIA OR INFARCT. THERE ARE ANEURYSM/VESSEL CHARACTERISTICS, DEVICE SELECTION, AND OPERATOR TECHNIQUE THAT MAY HAVE CONTRIBUTED TO THE EVENT, RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. THE DEVICE WAS LEFT IMPLANTED IN THE PATIENT WITHOUT FULL EXPANSION OF THE PROXIMAL MARKERS; HOWEVER, IT WAS REPORTED THERE WAS NO EVIDENCE OF OBSTRUCTED BLOOD FLOW. SINCE THE ALLEGED DEVICE DEFICIENCY REQUIRED ADDITIONAL INTERVENTIONS (I.E., USE OF A GUIDEWIRE TO MASSAGE THE STENT AND A BALLOON CATHETER TO DILATE THE VESSEL) IN AN EFFORT TO FULLY EXPAND THE STENT AND PRECLUDE PATIENT COMPLICATIONS, THE 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 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 ANGIOPLASTY PROCEDURE, THE PHYSICIAN RELEASED THE 4MM X 23MM NO TIP ENTERPRISE¿ 2 VASCULAR RECONSTRUCTION DEVICE (ENCR402300 / 9242471) IN THE TARGET SITE. THE DISTAL MARKERS OPENED WELL, BUT THE TWO PROXIMAL MARKERS WERE CONVERGED AND COULD NOT EXPAND. A DELIVERY WIRE WAS USED TO ¿MASSAGE¿ THE PROXIMAL MARKERS, BUT THEY WERE STILL UNABLE TO OPEN COMPLETELY. AFTER THE PHYSICIAN USED A BALLOON CATHETER (UNSPECIFIED BRAND) TO DILATE, THE PROXIMAL MARKERS WERE STILL NOT COMPLETELY OPENED. IT WAS REPORTED THAT ¿THE PHYSICIAN THEN COMPLETED THE PROCEDURE.¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET VESSEL OF THE ANGIOPLASTY PROCEDURE WAS THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THERE WERE NO VESSEL NOR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED INCOMPLETE EXPANSION. THERE WAS NO EVIDENCE OF OBSTRUCTED BLOOD FLOW DUE TO THE REPORTED ISSUE. THE STENT REMAINS IMPLANTED. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER; WHICH WAS A CERENOVUS MICROCATHETER. THE INFORMATION INDICATED THAT AFTER THE PHYSICIAN USED A BALLOON CATHETER (UNSPECIFIED COMPETITOR BRAND) FOR DILATION, THE PROXIMAL MARKERS OF THE STENT WERE STILL NOT COMPLETELY OPENED. THE DOCTOR THEN COMPLETED THE PROCEDURE. FURTHER DETAILS COULD NOT BE OBTAINED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT AND THE 10-MINUTE PROCEDURE EXTENSION WAS NOT CONSIDERED TO BE CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831346 CERENOVUS ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 9242471 10886704075288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention BALLOON CATHETER (UNSPECIFIED BRAND)| MICROCATHETER