BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5613048 · Received April 27, 2016

    Report

    Report Number
    1226348-2016-00073
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    November 30, 2015
    Report Date
    April 12, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL/FINAL REPORT. UDI: UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN PRODUCT INFO WERE UNSUCCESSFUL, UDI UNAVAILABLE. IN THE LITERATURE ARTICLE ¿A FINITE ELEMENT METHOD TO PREDICT ADVERSE EVENTS IN INTRACRANIAL STENTING USING MICROSTENTS: IN VITRO VERIFICATION AND PATIENT SPECIFIC CASE STUDY¿ BY IANNACCONE ET AL, PUBLISHED ANNALS OF BIOMEDICAL ENGINEERING, VOL. 44, NO. 2, FEBRUARY 2016 (_ 2015) PP. 442¿452 DOI: 10.1007/S10439-015-1505-2, IT WAS REPORTED THAT USING AN UNKNOWN 22MM ENTERPRISE STENT IN AN IN VITRO SIMULATION THERE WAS INCOMPLETE STENT EXPANSION. PER THE ARTICLE: ¿CLINICAL STUDIES HAVE DEMONSTRATED THE EFFICACY OF STENT SUPPORTED COILING FOR INTRA-CRANIAL ANEURYSM TREATMENT. DESPITE ENCOURAGING OUTCOMES, SOME MATTERS ARE YET TO BE ADDRESSED. IN PARTICULAR CLOSED STENT DESIGNS ARE INFLUENCED BY THE DELIVERY TECHNIQUE AND MAY SUFFER FROM UNDER-EXPANSION, WITH THE TYPICAL EFFECT OF ¿¿HUGGING¿¿ THE INNER CURVATURE OF THE VESSEL WHICH SEEMS RELATED TO ADVERSE EVENTS. IN THIS STUDY WE PROPOSE A NOVEL FINITE ELEMENT (FE) ENVIRONMENT TO STUDY POTENTIAL FAILURE ABLE TO REPRODUCE THE MICROCATHETER ¿¿PULLBACK¿ ¿DELIVERY TECHNIQUE. WE FIRST VERIFIED OUR PROCEDURE WITH PUBLISHED IN VITRO DATA AND THEN REPLICATED THE INTERVENTION ON ONE PATIENT TREATED WITH A 4.5 9 22 MM ENTERPRISE MICROSTENT. RESULTS SHOWED GOOD AGREEMENT WITH THE IN VITRO TEST, CATCHING BOTH SIZE AND LOCATION OF THE MALAPPOSED AREA.¿ THE INCOMPLETE EXPANSION WAS NOT VISUALIZED IN THE LIVE PATIENT PROCEDURE THAT THE IN VITRO MODEL WAS DESIGNED TO REPLICATE. AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/ LOT NUMBER, IS AVAILABLE. BASED ON THE INFORMATION, THE EVENT WAS NOT CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. A STERILE LOT WAS NOT PROVIDED THEREFORE A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT COULD NOT BE PERFORMED. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿A FINITE ELEMENT METHOD TO PREDICT ADVERSE EVENTS IN INTRACRANIAL STENTING USING MICROSTENTS: IN VITRO VERIFICATION AND PATIENT SPECIFIC CASE STUDY¿ BY IANNACCONE ET AL, PUBLISHED ANNALS OF BIOMEDICAL ENGINEERING, VOL. 44, NO. 2, FEBRUARY 2016 (_ 2015) PP. 442¿452 DOI: 10.1007/S10439-015-1505-2, IT WAS REPORTED THAT USING AN UNKNOWN 22MM ENTERPRISE STENT IN AN IN VITRO SIMULATION THERE WAS INCOMPLETE STENT EXPANSION. PER THE ARTICLE: ¿CLINICAL STUDIES HAVE DEMONSTRATED THE EFFICACY OF STENT SUPPORTED COILING FOR INTRA-CRANIAL ANEURYSM TREATMENT. DESPITE ENCOURAGING OUTCOMES, SOME MATTERS ARE YET TO BE ADDRESSED. IN PARTICULAR CLOSED STENT DESIGNS ARE INFLUENCED BY THE DELIVERY TECHNIQUE AND MAY SUFFER FROM UNDER-EXPANSION, WITH THE TYPICAL EFFECT OF ¿¿HUGGING¿¿ THE INNER CURVATURE OF THE VESSEL WHICH SEEMS RELATED TO ADVERSE EVENTS. IN THIS STUDY WE PROPOSE A NOVEL FINITE ELEMENT (FE) ENVIRONMENT TO STUDY POTENTIAL FAILURE ABLE TO REPRODUCE THE MICROCATHETER ¿¿PULLBACK¿ ¿DELIVERY TECHNIQUE. WE FIRST VERIFIED OUR PROCEDURE WITH PUBLISHED IN VITRO DATA AND THEN REPLICATED THE INTERVENTION ON ONE PATIENT TREATED WITH A 4.5 9 22 MM ENTERPRISE MICROSTENT. RESULTS SHOWED GOOD AGREEMENT WITH THE IN VITRO TEST, CATCHING BOTH SIZE AND LOCATION OF THE MALAPPOSED AREA.¿ THE INCOMPLETE EXPANSION WAS NOT VISUALIZED IN THE LIVE PATIENT PROCEDURE THAT THE IN VITRO MODEL WAS DESIGNED TO REPLICATE. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267246 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1