BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX23MM NO TIP

    MDR report key: 17210404 · Received June 27, 2023

    Report

    Report Number
    3008114965-2023-00381
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    June 12, 2023
    Report Date
    August 11, 2023
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    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). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED IN THE PRODUCT ANALYSIS LAB ON 08-AUG-2023. THE RETURNED PRODUCT IS PENDING EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 4MM X 23MM NO TIP ENTERPRISE¿ 2 VASCULAR RECONSTRUCTION DEVICE WAS RETURNED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. THE STENT COMPONENT WAS OBSERVED STILL INSIDE THE INTRODUCER AND STILL ATTACHED TO THE DELIVERY WIRE. NO APPEARANCE OF DAMAGES WERE OBSERVED. THE DEVICE UNDERWENT MICROSCOPIC INSPECTION. NO DAMAGES WERE OBSERVED ON THE STENT COMPONENT. RESIDUES OF DRIED SALINE SOLUTION WERE NOTED ALONG THE ENTIRE LENGTH OF THE ENTERPRISE STENT. A FUNCTIONAL TEST WAS PERFORMED IN WHICH THE ENTERPRISE SYSTEM WAS SECURED INTO A LAB SAMPLE MICROCATHETER THROUGH A LAB SAMPLE SYRINGE AND ROTATING HEMOSTASIS VALVE (RHV). THE SYSTEM WAS FLUSHED, AND THE ENTERPRISE SYSTEM WAS ADVANCED THROUGH THE MICROCATHETER WITHOUT NOTICEABLE RESISTANCE. THE STENT WAS DEPLOYED AND INSPECTED UNDER MAGNIFICATION. IT WAS NOTED THAT THE STRUTS ON ONE SECTION OF THE STENT WERE CRUSHED DOWN, KEEPING THE STENT FROM FULLY EXPANDING. NO BROKEN CONDITION ON THE STRUTS WERE FOUND, AND RESIDUES OF PARYLENE COATING WERE NOTED. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 7161628. 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. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT THIS TYPE OF DAMAGES FROM LEAVING THE FACILITY. THE ISSUE REPORTED REGARDING THE INCOMPLETELY EXPANDED STENT COMPONENT WAS CONFIRMED BASED ON THE CRUSHED CONDITION OF THE STRUTS OBSERVED. THIS CONDITION, ALONG WITH THE DELAMINATION OF THE PARYLENE COATING SUGGEST THAT THE DEVICE WAS INADVERTENTLY SUBJECTED TO EXCESSIVE FORCE DURING MANIPULATION. THE COMPRESSED CONDITION OF THE STRUTS RESULTED IN THE LACK OF PROPER OPENING BEHAVIOR OF THE STENT. WITH THE LIMITED INFORMATION AVAILABLE, THE ROOT CAUSE OF THE FAILURE MODE OBSERVED REMAINS INCONCLUSIVE; HOWEVER, THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT RESULTS FROM A DEFECT INHERENTLY RELATED TO THE DEVICE. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DOES CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE TO A NEW ONE. IF RESISTANCE IS FELT WHILE RECAPTURING THE STENT, DO NOT CONTINUE TO RECAPTURE THE DEVICE. WITHDRAW THE INFUSION CATHETER SLIGHTLY TO UNSHEATHE THE STENT (WITHOUT EXCEEDING THE RECAPTURE LIMIT), AND THEN ATTEMPT TO RECAPTURE THE STENT AGAIN. 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. UPDATED SECTIONS: B.4, G.3, G.6. H.2, H.3, H.6, AND H.10. 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, 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. SECTION E.1: INITIAL REPORTER ADDRESS LINE 1: (B)(6). SECTION E.1: INITIAL REPORTER ADDRESS LINE 2:(B)(6). SECTION H.3: 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 LAB REVIEWED THE PHOTO INCLUDED IN THE COMPLAINT. THE REVIEW IS DOCUMENTED BELOW. [PHOTO REVIEW]: THE PHOTO ATTACHED TO THE COMPLAINT FILE SHOWED THE STENT PARTIALLY OUTSIDE OF THE INTRODUCER; IT WAS NOTED THAT THE STENT STILL REMAINS ATTACHED TO THE DELIVERY SYSTEM. NO DAMAGES OR ANOMALIES WERE OBSERVED. THE DELIVERY WIRE AND THE INTRODUCER WERE SHOWN ONLY AT THEIR DISTAL PORTION; NO DAMAGES WERE OBSERVED. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 7161628. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED ISSUE IN THE COMPLAINT ABOUT THE INCOMPLETE STENT EXPANSION COULD NOT BE CONFIRMED AS THE STENT COMPONENT NEEDS TO BE COMPLETELY DETACHED FROM THE UNIT TO EVALUATE THE SHAPE OF THE EXPANSION. IN ADDITION, NO VISIBLE DAMAGES WERE OBSERVED ON THE STENT THAT CONTRIBUTED TO THE REPORTED FAILURE. THIS INVESTIGATION WAS PERFORMED BASED ON THE ONE (1) PHOTO PROVIDED. IF THE PRODUCT IS RECEIVED, AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITION OF THE DEVICE RECEIVED. 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 THE PATIENT SUFFERING FROM A LEFT POSTERIOR COMMUNICATING SEGMENT ANEURYSM UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE COMPLAINT DEVICE, A 4MM X 23MM NO TIP ENTERPRISE¿ 2 VASCULAR RECONSTRUCTION DEVICE ((B)(4)) WAS PLACED IN THE TARGET LOCATION. THE PHYSICIAN TRIED TO RELEASE THE STENT; IT WAS FOUND THAT THE STENT TIP WAS UNABLE TO OPEN. THE PHYSICIAN RETRACTED THE STENT AND REPLACED IT WITH NEW DEVICE TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ONE PHOTO WAS INCLUDED IN THE COMPLAINT. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET ANEURYSM WAS A REGULAR UNRUPTURED ANEURYSM 2.1 MM IN LENGTH AND 2.0 MM IN WIDTH. THERE WERE NO VESSEL OR 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 TEMPERATURE INDICATOR LABEL ON THE INNER POUCH HAD BEEN CHECKED AND CONFIRMED TO BE WITHIN ACCEPTABLE CRITERIA. NOTHING UNUSUAL WAS NOTED ABOUT THE SYSTEM PRIOR TO USE. THE MICROCATHETER USE WAS A CERENOVUS MICROCATHETER; HOWEVER THE CATALOG AND LOT NUMBER ARE NOT OBTAINABLE. THERE HAD BEEN NO RESISTANCE DURING THE ADVANCEMENT OF THE STENT THROUGH THE MICROCATHETER. THE INCOMPLETE EXPANSION OF THE STENT DID NOT RESULT IN STENT MIGRATION OR STENT EMBOLIZATION. THE REPLACEMENT STENT WAS ANOTHER 4MM X 23MM NO TIP ENTERPRISE¿ 2 VASCULAR RECONSTRUCTION DEVICE ((B)(4)). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT OR ANY PATIENT ADVERSE EVENT. THE REPORTED ISSUE DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930729 ENTERPRISE2 4MMX23MM NO TIP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 7161628

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MICROCATHETER