BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE2 4MMX23MM NO TIP

    MDR report key: 19274103 · Received May 8, 2024

    Report

    Report Number
    3008114965-2024-00451
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 27, 2024
    Report Date
    June 10, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    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). 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. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. THE PRODUCT ANALYSIS TEAM REVIEWED THE PHOTO INCLUDED IN THE COMPLAINT. THE REVIEW IS DOCUMENTED BELOW. [PHOTO REVIEW]: IN THE PHOTO INCLUDED IN THE COMPLAINT, ONLY A DETACHED STENT CAN BE OBSERVED. THE REST OF THE DEVICE IS NOT SHOWN IN THE PHOTO AND NO FURTHER DAMAGES COULD BE NOTED ON THE STENT AS IT IS SHOWN EXPANDED AND IN GOOD CONDITION (I.E., NO KINKS, NO BENDS, AND NO BROKEN STRUTS OBSERVED). LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 8639209. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE ISSUE REPORTED REGARDING THE STENT BEING SEPARATED FROM THE DELIVERY WIRE WAS CONFIRMED DUE TO THE DETACHED CONDITION OF THE STENT. HOWEVER, THE ISSUES REPORTED REGARDING THE STENT BEING PARTIALLY EXPANDED AND TWISTED COULD NOT BE CONFIRMED AS THE STENT WAS NOTED TO BE FULLY EXPANDED NO STRUCTURAL DAMAGE COULD BE NOTED. THE ISSUE REPORTED REGARDING THE PROXIMAL STENT MARKERS MIGRATING ON THE IMAGE CANNOT BE EVALUATED SINCE THE REPORTED ISSUE IS SPECIFIC TO THE PATIENT AND PROCEDURE AT THE TIME OF OCCURRENCE AND CANNOT BE EVALUATED THROUGH A PHOTO. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTOS PROVIDED. IF THE PRODUCT IS RECEIVED AFTER THIS INVESTIGATION, AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. STENT KINKING/BENDING WHILE IN PATIENT CAN RESULT IN THE STENT NOT FULLY APPOSING TO THE VESSEL WALL AND MAY RESULT IN THROMBOSIS. THE INCOMPLETE EXPANSION AND MIGRATION OF THE ENTERPRISE 2 STENT CAN POTENTIALLY LEAD TO THROMBOSIS OR EMBOLIZATION, RESULTING IN ISCHEMIA OR INFARCT. ADDITIONALLY, THE PREMATURE DETACHMENT OF THE STENT MAY LEAD TO DAMAGE OF HEALTHY INTIMA, POSSIBLE SIDE BRANCH OCCLUSION, ISCHEMIA, INFARCT AND/OR THE NEED FOR ADDITIONAL INTERVENTION. CLINICAL AND PROCEDURAL FACTORS, INCLUDING VESSEL CHARACTERISTICS/TORTUOSITY, POSSIBLE VASOSPASM, AND MECHANICAL MANIPULATION OF DEVICES WITHIN THE ARTERY, ARE ALL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. IN THIS CASE, THERE WERE NO REPORTS OF PATIENT HARM; HOWEVER, THE EVENTS RESULTED IN A 15-MINUTE PROCEDURAL DELAY AND THE PHYSICIAN WAS REQUIRED TO PERFORM THE ADDITIONAL SURGICAL INTERVENTION OF REMOVING THE MICROCATHETER AND STENT FROM THE PATIENT AND IMPLANTING A NEW STENT TO PRECLUDE PATIENT HARM. BASED ON THIS REQUIRED SURGICAL INTERVENTION, THIS EVENT MEETS US FDA REPORTING UNDER CRITERIA 21 CFR 803 WITH THE CLASSIFICATION OF ¿SERIOUS INJURY.¿ THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. THE COMPLAINT PRODUCT WAS RETURNED AND RECEIVED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 4MM X 23MM NO TIP ENTERPRISE¿ 2 VASCULAR RECONSTRUCTION DEVICE WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. IT WAS NOTED THAT ONLY THE DETACHED STENT WAS RETURNED FOR EVALUATION. THE STENT COMPONENT WAS INSPECTED UNDER THE MICROSCOPE AND AS OBSERVED IN THE PHOTOS INCLUDED IN THE COMPLAINT, NO ABNORMALITIES WERE FOUND ON THE STENT (I.E., NO BROKEN STRUTS, NO KINKS). BOTH ENDS OF THE STENT WERE NOTED TO BE COMPLETELY EXPANDED. THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT REGARDING THE STENT MARKER BANDS CONVERGING AND THEN TWISTED WERE NOT CONFIRMED SINCE THE STENT WAS NOTED AS ALREADY EXPANDING ON BOTH ENDS AND NO DAMAGES WERE FOUND DURING THE INSPECTION. IT IS POSSIBLE THAT THE MARKER BANDS MAY HAVE CONVERGED TOGETHER BUT OPPOSED TO THE VESSEL WALL DURING THE PROCEDURE. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER FACTORS THAT CONTRIBUTED TO THE FAILURE ENCOUNTERED DURING THE PROCEDURE THAT COULD NOT BE REPLICATED IN THE LABORATORY SETTING. THE ISSUE DOCUMENTED REGARDING THE DELIVERY WIRE BEING SEPARATED FROM THE STENT BODY WAS CONFIRMED SINCE THE STENT WAS NOTED AS ALREADY SEPARATED FROM THE DELIVERY SYSTEM. HOWEVER, WITHOUT THE REST OF THE COMPONENTS, THE ROOT CAUSE OF THE FAILURE ENCOUNTERED CANNOT BE DETERMINED. THE ISSUE DOCUMENTED IN THE COMPLAINT THAT THE STENT MARKERS POSITION HAD MIGRATED CANNOT BE REPLICATED IN THE LABORATORY SINCE THE REPORTED ISSUE IS SPECIFIC TO THE PATIENT AND PROCEDURE AT THE TIME OF OCCURRENCE. HOWEVER, STENT MIGRATION IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT SUCH ISSUES FROM OCCURRING. WITH THE LIMITED INFORMATION AVAILABLE, A CONCLUSIVE CAUSE CANNOT BE DETERMINED; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION AND OPERATOR'S TECHNIQUE, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AT THIS TIME, THERE IS NO EVIDENCE TO SUPPORT THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 8639209. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DOES CONTAIN THE FOLLOWING RECOMMENDATIONS: MAINTAIN ADEQUATE STENT LENGTH (APPROXIMATELY 5 MM) ON EACH SIDE OF THE ANEURYSM NECK TO ENSURE APPROPRIATE NECK COVERAGE. SELECT A STENT LENGTH THAT IS AT LEAST 10 MM LONGER THAN THE ANEURYSM NECK TO MAINTAIN A MINIMUM OF 5 MM ON EITHER SIDE OF THE ANEURYSM NECK. A LARGE DIFFERENTIAL IN DIAMETER BETWEEN THE PROXIMAL AND DISTAL SEGMENTS OF THE PARENT VESSEL MAY INCREASE THE RISK OF STENT MIGRATION. DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE A NEW ONE. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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. 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). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE ON 03-JUN-2024. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. 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 PHYSICIAN STARTED TO RELEASE THE STENT, A 4MM X 23MM NO TIP ENTERPRISE¿ 2 VASCULAR RECONSTRUCTION DEVICE (ENCR402300 / 8639209) AT THE TARGET SITE. THE DISTAL MARKERS OF THE STENT WERE WELL OPENED, THE MICROCATHETER (COMPETITOR BRAND) WAS RETRACTED TO RELEASE THE STENT AND THE MICROCATHETER WAS REMOVED FROM THE PATIENT. AFTER THE STENT WAS RELEASED, THE THREE MARKERS AT THE PROXIMAL END OF THE STENT CONVERGED AND COULD NOT BE OPENED AS EXPECTED. IT WAS NOTED THAT WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE DELIVERY WIRE, IT COULD NO NOT BE RETRACTED. THE PROXIMAL STENT MARKERS LOCATION MIGRATED ON IMAGE. THE STENT WAS NOTED TO BE TWISTED. THE PHYSICIAN ADVANCED THE INTERMEDIATE CATHETER (COMPETITOR BRAND) TO COVER THE STENT AND THE STENT WAS REMOVED WITH THE INTERMEDIATE CATHETER OUT OF THE PATIENT¿S ANATOMY. THE PHYSICIAN OBSERVED THAT THE DELIVERY WIRE HAS SEPARATED FROM THE STENT BODY. THE PHYSICIAN REPLACED BOTH THE MICROCATHETER AND THE STENT WITH COMPETITOR BRANDS TO USE WITH THE SAME INTERMEDIATE CATHETER TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 15-MINUTES. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. ONE PHOTO WAS INCLUDED IN THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145805 ENTERPRISE2 4MMX23MM NO TIP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 8639209

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention