BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX16MM NO TIP

    MDR report key: 11019381 · Received December 16, 2020

    Report

    Report Number
    3008114965-2020-00593
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 3, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704075349
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A SURGICAL PROCEDURE FOR THE COMMUNICATING ANEURYSM, CATHETERIZATION OF THE RIGHT A2 SEGMENT USING A PROWLER MICROCATHETER (MC) AND A TERUMO 16'-90 °WAS USED. WHEN DEPLOYMENT THE INTRACRANIAL, THE STENTS OF TWO 4MMX23MM ENTERPRISE2 NO TIP (ENC402300, 11193908) AND (ENC402300, 5711204) GOT RELEASED INSIDE THE CATHETER AND SO IT WAS NOT POSSIBLE TO RECAPTURE THEM ANYMORE. A THIRD ENTERPRISE STENT DELIVERY SYSTEM (ENC403012, 1161318) WAS USED WITH SUCCESS. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION FOR THE PATIENT. THE PATIENT HAD A SCANNER AND MRI AS PART OF A HEADACHE ASSESSMENT ASSOCIATED WITH A PHASIC DISORDER THAT HAD BEEN EVOLVING FOR SEVERAL WEEKS. THE IMAGES SHOW A GIANT ANEURYSM PARTIALLY THROMBOSED OF THE LEFT SYLVIC BIFURCATION, RESPONSIBLE FOR A LEFT FRONTOTEMPORAL PERI-LESIONAL EDEMA EXPLAINING THE SEMIOLOGY. IT WAS ALSO FORTUITOUSLY EVIDENCED AN ANEURYSM OF THE ANTERIOR COMMUNICATING COMPLEX OF ABOUT 10 MM. ON (B)(6) 2020, THE PATIENT UNDERWENT A TEMPORO-SYLVIC BYPASS BY ANASTOMOSIS BETWEEN THE LEFT SUPERFICIAL ARTERY AND THE TEMPORAL BRANCH OF THE LEFT MIDDLE CEREBRAL ARTERY ALLOWING THE EXCLUSION OF THE GIANT ANEURYSM BY CLIP PLACEMENT. IN VIEW OF THIS LONG AND COMPLICATED INTERVENTION, THE MANAGEMENT OF THE COMMUNICATING ANEURYSM IS DONE LATER BY ENDOVASCULAR ROUTE AND PLACEMENT OF COILS AND AN INTRACRANIAL STENT AT THE RELATIVELY WIDE ANEURYSM NECK. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, NO PRODUCT INVESTIGATION CAN BE PERFORMED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING, AND PACKAGING OF THE LOT: 5711204 THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT OF ¿STENT - DEPLOYMENT DIFFICULTY-PREMATURE/IN MICROCATHETER¿ 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. PREMATURE STENT DEPLOYMENT IN MICROCATHETER IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE IN THE INTRACRANIAL ARTERIES. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT DEVICES; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION, ANEURYSM SIZE AND VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. 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). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2020-00592 AND 3008114965-2020-00593. 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 · 1

    AS REPORTED BY THE FIELD, DURING A SURGICAL PROCEDURE FOR THE COMMUNICATING ANEURYSM, CATHETERIZATION OF THE RIGHT SEGMENT USING A PROWLER MICROCATHETER (MC) AND A TERUMO 16'-90 °WAS USED. WHEN DEPLOYMENT OF THE INTRACRANIAL, THE STENTS OF TWO 4MMX23MM ENTERPRISE2 NO TIP (ENC402300, 11193908) AND (ENC402300, 5711204) GOT RELEASED INSIDE THE CATHETER AND SO IT WAS NOT POSSIBLE TO RECAPTURE THEM ANYMORE. A THIRD ENTERPRISE STENT DELIVERY SYSTEM (ENC403012, 1161318) WAS USED WITH SUCCESS. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION FOR THE PATIENT. THE PATIENT HAD A SCANNER AND MRI AS PART OF A HEADACHE ASSESSMENT ASSOCIATED WITH A PHASIC DISORDER THAT HAD BEEN EVOLVING FOR SEVERAL WEEKS. THE IMAGES SHOW A GIANT ANEURYSM PARTIALLY THROMBOSED OF THE LEFT SYLVIC BIFURCATION, RESPONSIBLE FOR A LEFT FRONTOTEMPORAL PERI-LESIONAL EDEMA EXPLAINING THE SEMIOLOGY. IT WAS ALSO FORTUITOUSLY EVIDENCED AN ANEURYSM OF THE ANTERIOR COMMUNICATING COMPLEX OF ABOUT 10 MM. ON (B)(6) 2020, THE PATIENT UNDERWENT A TEMPORO-SYLVIC BYPASS BY ANASTOMOSIS BETWEEN THE LEFT SUPERFICIAL ARTERY AND THE TEMPORAL BRANCH OF THE LEFT MIDDLE CEREBRAL ARTERY ALLOWING THE EXCLUSION OF THE GIANT ANEURYSM BY CLIP PLACEMENT. IN VIEW OF THIS LONG AND COMPLICATED INTERVENTION, THE MANAGEMENT OF THE COMMUNICATING ANEURYSM IS DONE LATER BY ENDOVASCULAR ROUTE AND PLACEMENT OF COILS AND AN INTRACRANIAL STENT AT THE RELATIVELY WIDE ANEURYSM NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485946 ENTERPRISE2 4MMX16MM NO TIP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL ENF401600 5711204 10886704075349

    Patients

    Seq Age Sex Outcome Treatment
    1 ENTERPRISE2 4MMX23MM NO TIP.| PROWLER MICROCATHETER.| TERUMO 16'-90 INTERVENTION SYSTEM.