BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX23MM

    MDR report key: 17873588 · Received October 4, 2023

    Report

    Report Number
    3008114965-2023-00680
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 19, 2023
    Report Date
    November 26, 2023
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    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. 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. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 8130016. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS: 3008114965-2023-00681. 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.

    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 (B)(6) 2023. THE RETURNED PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. UPDATED SECTIONS: B.4, D.9, G.3, G.6. H.2, H.3, H.6, AND H.10. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00680 AND 3008114965-2023-00681. 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 INVESTIGATION FINDING OF THE RETURNED DEVICE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 4MM X 23MM ENTERPRISE 2 STENT WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. THE DELIVERY SYSTEM WAS NOTED TO BE ATTACHED TO THE CONCOMITANT MICROCATHETER. THE STENT WAS NOTED TO BE PARTIALLY OUTSIDE THE TIP OF THE MICROCATHETER AND IT WAS NOTED TO STILL BE ATTACHED TO THE DELIVERY SYSTEM. A DRIED CLOT REMAINED IN THE STRUTS OF THE STENT. NO OTHER DAMAGES OR OTHER ANOMALIES WERE NOTED IN THE DEVICE DURING VISUAL INSPECTION. AN ATTEMPT WAS MADE TO REMOVE THE DELIVERY SYSTEM FROM THE MICROCATHETER, BUT STRONG RESISTANCE WAS FELT. AN ATTEMPT TO PUSH THE DELIVERY SYSTEM FORWARD, BUT IT WAS NOT POSSIBLE. THE ENTERPRISE DELIVERY SYSTEM WAS NOT ABLE TO BE MOVED. THE ISSUE REPORTED REGARDING THE STENT COMPONENT BEING IMPEDED IN THE MICROCATHETER WAS CONFIRMED BASED ON THE FINDINGS. THE DRIED CLOT OBSERVED SUGGESTS THAT AN ADEQUATE FLUSH WAS NOT MAINTAINED, RESULTING IN RESISTANCE THAT COULD HAVE LED TO THE STRONG RESISTANCE FELT DURING THE ADVANCEMENT OF THE ENTERPRISE SYSTEM. IT COULD BE REASONABLY SUGGESTED THAT THE DAMAGES NOTED IN THE INVOLVED MICROCATHETER ARE THE RESULT OF THE DIFFICULTIES EXPERIENCED DURING THE WITHDRAWAL OF THE STENT AS IT BECAME IMPEDED IN THE MICROCATHETER. 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. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 8130016. 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) CONTAINS THE FOLLOWING RECOMMENDATIONS: ¿ DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. ¿ 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. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00680 AND 3008114965-2023-00681. 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 COMPLAINT STENT, A 4MM X 23MM ENTERPRISE 2 STENT (ENCR402312 / 8130016) BECAME IMPEDED IN THE DISTAL END OF THE CONCOMITANT PROWLER SELECT PLUS MICROCATHETER (606S255X / 31032663) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN TRIED TO WITHDRAW THE STENT, BUT IT COULD NOT BE RETRACTED. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT¿S ANATOMY AND REPLACED THEM WITH NEW DEVICES (COMPETITOR BRAND(S)) TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED BY ABOUT 10 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 22-SEP-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE LIMITED INFORMATION INDICATED THAT A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE PHYSICIAN DID NOT CONSIDER THE 10-MINUTE EXTENSION OF THE PROCEDURE TO BE CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276983 ENTERPRISE2 4MMX23MM INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 8130016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PROWLER SELECT PLUS 150/5CM