BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX23MM

    MDR report key: 16589828 · Received March 22, 2023

    Report

    Report Number
    3008114965-2023-00181
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    March 13, 2023
    Report Date
    March 27, 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

    PRODUCT COMPLAINT #(B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, B5, G3, G6, H2, AND H10. SECTION B5: ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT 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. THERE WAS NO BLOOD FLOW RESTRICTION. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, THE PHYSICIAN REMOVED AN ENTERPRISE2 4MMX23MM INTRACRANIAL STENT (ENCR402312, 7190236) FROM THE PACKAGING, THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE UNSPECIFIED MICROCATHETER (MC) AND LOCKED WITH THE RHV. THE STENT WAS FLUSHED WITH SALINE AND DELIVERED TO THE TARGET POSITION. THE DOCTOR STARTED TO WITHDRAW THE MICROCATHETER TO RELEASE THE STENT, WHEN THE MICROCATHETER WAS RETRACTED TO RECAPTURE LIMIT POINT, THE DISTAL MARKERS OF THE STENT DID NOT OPEN. THE PHYSICIAN OBSERVED THE STENT FROM MULTIPLE ANGLES UNDER THE RAY, AND THE MARKERS WERE STILL UNABLE TO OPEN. A NEW STENT WAS SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT 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. THERE WAS NO BLOOD FLOW RESTRICTION. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. 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. INCOMPLETE STENT EXPANSION IS A KNOWN POTENTIAL PROCEDURAL COMPLICATIONS ASSOCIATED WITH THE ENTERPRISE 2 VRD. WITH THE INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE ASSOCIATED DEVICES, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. HOWEVER, THE EVENT MAY HAVE BEEN RELATED TO A COMBINATION OF MULTIPLE FACTORS EXPERIENCED IN THE CLINICAL SETTING RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. 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. 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). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. INITIAL REPORTER PHONE: (B)(6). 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 COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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). THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, THE PHYSICIAN REMOVED AN ENTERPRISE2 4MMX23MM INTRACRANIAL STENT (ENCR402312, 7190236) FROM THE PACKAGING, THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE UNSPECIFIED MICROCATHETER (MC) AND LOCKED WITH THE RHV. THE STENT WAS FLUSHED WITH SALINE AND DELIVERED TO THE TARGET POSITION. THE DOCTOR STARTED TO WITHDRAW THE MICROCATHETER TO RELEASE THE STENT, WHEN THE MICROCATHETER WAS RETRACTED TO RECAPTURE LIMIT POINT, THE DISTAL MARKERS OF THE STENT DID NOT OPEN. THE PHYSICIAN OBSERVED THE STENT FROM MULTIPLE ANGLES UNDER THE RAY, AND THE MARKERS WERE STILL UNABLE TO OPEN. A NEW STENT WAS SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451415 ENTERPRISE2 4MMX23MM INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 7190236

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED MICROCATHETER