BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EU 4.5X22MM STENT 12 MM DW TIP

    MDR report key: 12057838 · Received June 24, 2021

    Report

    Report Number
    3008114965-2021-00260
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    June 4, 2021
    Report Date
    June 9, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10878528009495
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING. HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. 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) UPDATED SECTIONS ON THIS MEDWATCH REPORT: G3, G6, H2, H3, H6 AND H10. 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-ASSISTED COIL EMBOLIZATION FOR ANEURYSMS, A 4.5X22MM (ENC452212, 5852782) COULDN¿T CROSS THROUGH THE UNSPECIFIED MICROCATHETER (MC). THE PHYSICIAN TRIED TO WITHDRAW THE STENT BUT FAILED AND THE STENT WAS DETACHED IN MICROCATHETER WITHOUT EXPECTATION. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE STENT DELIVERY SYSTEM OUTSIDE OF THE PATIENT. THE PHYSICIAN SWITCHED TO ANOTHER NEW MC AND A NEW STENT DELIVERY SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NOT PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. ONLY A PHOTO OF THE EXTERNAL BOX OF THE EU 4.5X22MM STENT 12 MM DW TIP WAS PROVIDED AT THE TIME OF COMPLAINT ENTRY. NO DAMAGES COULD BE NOTED ON IT. THE DEVICE COULD NOT BE NOTED IN THE PICTURE. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOT 5852782. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. ONE NON-STERILE UNIT EU 4.5X22MM STENT 12 MM DW TIP WAS RECEIVED INSIDE OF A POUCH. THE DEVICE WAS INSPECTED, AND IT WAS NOTED THAT THE DEVICE WAS RETURNED SEPARATED. THE INTRODUCER, STENT AND DELIVERY WIRE WERE INSPECTED, AND THEY WERE FOUND IN GOOD NORMAL CONDITIONS, NO DAMAGES OR ANOMALIES WERE OBSERVED ON THE COMPONENTS OF THE DEVICE. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE THE DEVICE WAS RETURNED SEPARATED; THE STENT WAS DETACHED FROM THE DELIVERY WIRE. IT IS NECESSARY THAT THE STENT IS STILL INSIDE OF THE INTRODUCER TUBE TO PERFORM THE FUNCTIONAL ANALYSIS. THE PRODUCT WAS RETURNED TO CERENOVUS FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. THE VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE DEVICE WAS RETURNED SEPARATED. THE STENT, INTRODUCER AND DELIVERY WIRE WERE INSPECTED, AND THEY WERE FOUND IN GOOD NORMAL CONDITIONS, NO DAMAGES OR ANOMALIES WERE OBSERVED ON THE DEVICE. FUNCTIONAL TEST COULD NOT BE PERFORMED DUE THE DEVICE WAS RETURNED SEPARATED; THE STENT WAS DETACHED FROM THE DELIVERY WIRE. THE CUSTOMER COMPLAINTS REGARDING ¿DELIVERY WIRE - IMPEDED IN MICROCATHETER WITH LOSS OF CEREBRAL TARGET POSITION¿ AND ¿STENT - DEPLOYMENT DIFFICULTY-PREMATURE/IN MICROCATHETER¿ COULD NOT BE DUPLICATED DUE TO THE STENT WAS RETURNED DETACHED FROM THE REST OF THE DEVICE. ALTHOUGH THERE IS NO EVIDENCE THAT THE STENT WAS DEPLOYED INSIDE THE MICROCATHETER SINCE THE MICROCATHETER WAS NOT RETURNED FOR EVALUATION, THE CUSTOMER COMPLAINT WAS CONFIRMED SINCE THE STENT WAS RETURNED DETACHED FROM THE REST OF THE DEVICE. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES WERE IDENTIFIED. IMPEDED IN MICROCATHETER AND DEPLOYMENT DIFFICULTY-PREMATURE/IN MICROCATHETER ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THE ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE IN THE INTRACRANIAL ARTERIES. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. ALTHOUGH NO CONCLUSION COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING PRECAUTION: ¿ IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. ¿ DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE A NEW ONE. ¿ IF RESISTANCE IS FELT WHILE RECAPTURING THE STENT, DO NOT CONTINUE TO RECAPTURE THE DEVICE. WITHDRAW THE INFUSION CATHETER SLIGHTLY TO UN-SHEATH THE STENT (WITHOUT EXCEEDING THE RECAPTURE LIMIT), AND THEN ATTEMPT TO RECAPTURE THE STENT AGAIN. ASSIGNMENT OF ROOT CAUSE FOR THE EVENTS REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION AND DEVICE INTERACTION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURES. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IF INFORMATION IS PROVIDED AT A LATER DATE, THE FILE WILL BE REOPENED AND PROCESSED ACCORDINGLY. 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.

    Additional Manufacturer Narrative · 1

    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. ONLY A PHOTO OF THE EXTERNAL BOX OF THE EU 4.5X22MM STENT 12 MM DW TIP WAS PROVIDED, NO DAMAGES COULD BE NOTED ON IT. THE DEVICE COULD NOT BE NOTED IN THE PICTURE. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOT 5852782. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED CONDITION ¿STENT- DEPLOYMENT DIFFICULTY-PREMATURE/IN MICROCATHETER¿ COULD NOT BE EVALUATED BASED ON THE PICTURE. THE REPORTED CONDITION ¿DELIVERY WIRE - IMPEDED IN MICROCATHETER WITH LOSS OF CEREBRAL TARGET POSITION¿ COULD NOT BE EVALUATED BASED ON THE PICTURE. THE MRE SUGGESTS THAT THE FAILURE REPORTED BY THE CUSTOMER COULD NOT BE RELATED TO THE MANUFACTURING PROCESS. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. FURTHER INVESTIGATION WILL BE PERFORMED ONCE THE DEVICE RETURNS FOR ANALYSIS. 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 · 1

    AS REPORTED BY THE FIELD, DURING A STENT ASSISTED COIL EMBOLIZATION FOR ANEURYSMS, A 4.5X22MM (ENC452212, 5852782) COULDN'T CROSS THROUGH THE UNSPECIFIED MICROCATHETER (MC). THE PHYSICIAN TRIED TO WITHDRAW THE STENT BUT FAILED AND THE STENT WAS DETACHED IN MICROCATHETER WITHOUT EXPECTATION. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE STENT DELIVERY SYSTEM OUTSIDE OF THE PATIENT. THE PHYSICIAN SWITCHED TO ANOTHER NEW MC AND A NEW STENT DELIVERY SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NOT PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959401 EU 4.5X22MM STENT 12 MM DW TIP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 641CF3575 5852782 10878528009495

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED MICROCATHETER| UNSPECIFIED MICROCATHETER