BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX39MM NO TIP

    MDR report key: 12974903 · Received December 10, 2021

    Report

    Report Number
    3008114965-2021-00654
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    December 5, 2021
    Report Date
    January 25, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS UNCLEAR IF THE ENTERPRISE OR THE MC BECAME KINKED OR BENT AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. THERE WAS NO DAMAGE TO THE DEVICES WHEN THEY WERE REMOVED FROM THE PATIENT. THE PRODUCT/LOT NUMBER FOR THE PROWLER SELECT PLUS IS 606-S255X, 30481249. AN ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THERE WAS NO SIGNIFICANT PROLONGATION IN THE PROCEDURE DUE TO THE EVENT. COMPLAINT CONCLUSION: IT WAS REPORTED BY THE FIELD, DURING AN EMERGENT COIL EMBOLIZATION TO A LESION IN THE VERTEBRAL ARTERY (VA), AN ENTERPRISE2 4MMX39MM NO TIP INTRACRANIAL NEUROVASCULAR STENT (ENC403900, 5832089) WAS INSERTED INTO A PROWLER SELECT PLUS (UNKNOWN PRODUCT/LOT) MICROCATHETER (MC) AND TRIED TO DELIVER IT, BUT THERE WAS A HEAVY RESISTANCE FELT BETWEEN THE ENTERPRISE AND THE CATHETER. ALTHOUGH DELIVERY WAS ATTEMPTED SEVERAL TIMES, IT WAS NOT ABLE TO BE INSERTED. THEREFORE, THE COMPLAINT PRODUCT WAS CONFIRMED ONCE BY VISUALLY INSPECTED, BUT NOTHING IN PARTICULAR WAS ABLE TO BE CONFIRMED. ALTHOUGH THE PHYSICIAN CHANGED THE MICROCATHETER ONCE, THE SITUATION DID NOT CHANGE. BECAUSE IT WAS IN THE MIDDLE OF AN EMERGENT PROCEDURE, THE COMPLAINT PRODUCT WAS REMOVED. SINCE THERE WAS NO ENTERPRISE OF THE SAME SIZE, THE PHYSICIAN USED AN ENTERPRISE COIL WHICH REDUCED BY 1 SIZE. THE DELIVERY WAS POSSIBLE WITHOUT CHANGING THE MICROCATHETER, AND THE PROCEDURE WAS COMPLETED. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS UNCLEAR IF THE ENTERPRISE OR THE MC BECAME KINKED OR BENT AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. THERE WAS NO DAMAGE TO THE DEVICES WHEN THEY WERE REMOVED FROM THE PATIENT. THE PRODUCT/LOT NUMBER FOR THE PROWLER SELECT PLUS IS 606-S255X, 30481249. AN ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THERE WAS NO SIGNIFICANT PROLONGATION IN THE PROCEDURE DUE TO THE EVENT. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOT 5832089. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. RESISTANCE/FRICTION WITH LOSS OF MC CEREBRAL TARGET POSITION IS A KNOWN POTENTIAL PROCEDURAL COMPLICATION ASSOCIATED WITH THE ENTERPRISE 2 VRD. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE INSTRUCTIONS FOR USE (IFU) CONTAINS SEVERAL CAUTIONS RELATING TO THIS SITUATION, INCLUDING INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION/INTERACTION, VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. 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 · 0

    PRODUCT COMPLAINT#: (B)(4) SECTION G3. DATE RECEIVED BY MANUFACTURER IS 01/05/2022.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. INITIAL REPORTER: THE CUSTOMER CONTACT INFORMATION, INCLUDING NAME, OCCUPATION, PHONE, FAX, AND E-MAIL ADDRESS, WAS NOT REPORTED. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. (B)(6) MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOT 5832089. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE FIELD, DURING AN EMERGENT COIL EMBOLIZATION TO A LESION IN THE VERTEBRAL ARTERY (VA), AN ENTERPRISE2 4MMX39MM NO TIP INTRACRANIAL NEUROVASCULAR STENT (ENC403900, 5832089) WAS INSERTED INTO A PROWLER SELECT PLUS (UNKNOWN PRODUCT/LOT) MICROCATHETER (MC) AND TRIED TO DELIVER IT, BUT THERE WAS A HEAVY RESISTANCE FELT BETWEEN THE ENTERPRISE AND THE CATHETER. ALTHOUGH DELIVERY WAS ATTEMPTED SEVERAL TIMES, IT WAS NOT ABLE TO BE INSERTED. THEREFORE, THE COMPLAINT PRODUCT WAS CONFIRMED ONCE BY VISUALLY INSPECTED, BUT NOTHING IN PARTICULAR WAS ABLE TO BE CONFIRMED. ALTHOUGH THE PHYSICIAN CHANGED THE MICROCATHETER ONCE, THE SITUATION DID NOT CHANGE. BECAUSE IT WAS IN THE MIDDLE OF AN EMERGENT PROCEDURE, THE COMPLAINT PRODUCT WAS REMOVED. SINCE THERE WAS NO ENTERPRISE OF THE SAME SIZE, THE PHYSICIAN USED AN ENTERPRISE COIL WHICH REDUCED BY 1 SIZE. THE DELIVERY WAS POSSIBLE WITHOUT CHANGING THE MICROCATHETER, AND THE PROCEDURE WAS COMPLETED. A CONTINUOUS FLUSH WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875020 ENTERPRISE2 4MMX39MM NO TIP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 5832089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PROWLER SELECT PLUS.