BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX16MM NO TIP

    MDR report key: 15486474 · Received September 26, 2022

    Report

    Report Number
    3008114965-2022-00626
    Event Type
    Malfunction
    Date Received
    September 26, 2022
    Date of Event
    September 2, 2022
    Report Date
    November 7, 2022
    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

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. INITIAL REPORTER PHONE: (B)(6). 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. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, A 4MM X 16MM ENTERPRISE2 NO TIP STENT (ENCR401600, 7121771) PASSED THROUGH AN UNSPECIFIED MICROCATHETER (MC), AND THE PHYSICIAN TRIED TO RELEASE THE STENT. HOWEVER, THE STENT COULD NOT BE OPENED. THE PHYSICIAN REMOVED THE STENT OUTSIDE OF THE PATIENT¿S BODY, AND A NEW STENT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT IS UNKNOWN IF THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO RESISTANCE DURING THE ADVANCEMENT OF THE DEVICE. THE STENT DID NOT APPEAR DAMAGED. NO VESSEL OR ANEURYSM FACTORS MAY HAVE CONTRIBUTED TO THE INCOMPLETE EXPANSION. NO ADDITIONAL INTERVENTION WAS PERFORMED TO ATTEMPT TO EXPAND THE STENT. THE INCOMPLETE EXPANSION DID NOT RESULT IN STENT MIGRATION OR EMBOLIZATION OF THE STENT. THERE WAS NO BLOOD FLOW RESTRICTION. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. A NON-STERILE ENTERPRISE2 4MMX16MM NO TIP WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT THE STENT WAS RETURNED ALREADY DETACHED FROM THE UNIT. THE DELIVERY WIRE WAS INSPECTED, AND NO DAMAGES WERE NOTED ON IT. THE INTRODUCER WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS INSPECTED UNDER MICROSCOPIC MAGNIFICATION, AND THE DEPLOYED STENT WAS OBSERVED TO BE IN GOOD CONDITION; THERE WAS NO STRUCTURAL DAMAGE (I.E., NO BROKEN STRUTS, NO KINKS). NO OTHER DAMAGES WERE NOTED. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND IT INDICATED THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. CUSTOMER COMPLAINT REGARDING THE STENT NOT BEING ABLE TO OPEN WAS NOT CONFIRMED SINCE THE STENT WAS FOUND FULLY EXPANDED DURING THE ANALYSIS. WITH THE LIMITED INFORMATION AVAILABLE, THE ROOT CAUSE OF THE REPORTED FAILURE REMAINS INCONCLUSIVE; HOWEVER, THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT RESULTS FROM A DEFECT INHERENTLY RELATED TO THE DEVICE. A DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 7121771 WAS PERFORMED, AND IT INDICATED THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATION: MAINTAIN ADEQUATE STENT LENGTH (APPROXIMATELY 5MM) ON EACH SIDE OF THE ANEURYSM NECK TO ENSURE APPROPRIATE NECK COVERAGE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, A 4MM X 16MM ENTERPRISE2 NO TIP STENT (ENCR401600, 7121771) PASSED THROUGH AN UNSPECIFIED MICROCATHETER (MC) AND THE PHYSICIAN TRIED TO RELEASE THE STENT. HOWEVER, THE STENT COULD NOT BE OPENED. THE PHYSICIAN REMOVED THE STENT OUTSIDE OF THE PATIENT¿S BODY AND A NEW STENT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT IS UNKNOWN IF THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO RESISTANCE DURING THE ADVANCEMENT OF THE DEVICE. THE STENT DID NOT APPEAR DAMAGED. THERE WERE NO VESSEL OR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE INCOMPLETE EXPANSION. NO ADDITIONAL INTERVENTION WAS PERFORMED TO ATTEMPT TO EXPAND THE STENT. THE INCOMPLETE EXPANSION DID NOT RESULT IN STENT MIGRATION OR EMBOLIZATION OF THE STENT. THERE WAS NO BLOOD FLOW RESTRICTION. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588310 ENTERPRISE2 4MMX16MM NO TIP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 7121771

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED MICROCATHETER