BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6690006 · Received July 6, 2017

    Report

    Report Number
    1226348-2017-00097
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    July 18, 2012
    Report Date
    June 11, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED IN AN EFFORT TO SUPPORT THE CER SUBMISSION PROCESS, AS SUCH, THE ASSOCIATED TIME FRAME OF EVENT DATES INCLUDES BUT IS NOT LIMITED TO 20 YEARS. THESE ARTICLES ARE BEING REVIEWED ON A MONTHLY BASIS FOR SAFETY SIGNALS AND WILL BE FOLLOWED BY MONTHLY TRENDING ASSESSMENTS AS WELL AS PMS REVIEWS. EVENTS THAT CAPTURED SPECIFIC PATIENT DEVICE OR PROCEDURE INFORMATION ARE LISTED IN INDIVIDUAL COMPLAINTS. ARTICLE ATTACHED TO THIS MDR: KADKHADOYAN, Y., ET AL. (2012) RHODES, N., BLACKBURN, S. COMPARISON OF ENTERPRISE WITH NEUROFORM STENT-ASSISTED COILING OF INTRACRANIAL ANEURYSMS. AJR 2013; 200:872¿878. DATE OF EVENT, PRODUCT CODE, AND LOT NUMBER COULD NOT BE OBTAINED FROM THE AUTHOR. UDI: UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT PART NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. THIS IS AN INITIAL/FINAL MDR REPORT. CONCLUSION: THE PRODUCTS WERE NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBERS WERE NOT AVAILABLE; THEREFORE, A DHR COULD NOT BE PERFORMED. STROKE AND NEUROLOGICAL DEFICIT ARE KNOWN POTENTIAL ADVERSE EVENTS WITH USE OF THE ENTERPRISE STENT AND CEREBRAL STENTING PROCEDURES. BASED ON THE INFORMATION PROVIDED IN THE ARTICLE, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, PATIENT FACTORS OR CONCOMITANT DEVICES MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENTS BASED ON REVIEW OF COMPLAINT HISTORIES FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WERE RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿COMPARISON OF ENTERPRISE WITH NEUROFORM STENT-ASSISTED COILING OF INTRACRANIAL ANEURYSMS¿ BY YASHA KADKHODAYAN, NICHOLAS RHODES, SPIROS BLACKBURN, COLIN P. DERDEYN, DEWITTE T. CROSS, III, CHRISTOPHER J. MORAN, PUBLISHED AJR 2013; 200:872¿878, IT WAS REPORTED THAT THERE WERE ADVERSE EVENTS AND TECHNICAL COMPLICATIONS ASSOCIATED WITH THE USE OF UNKNOWN ENTERPRISE STENTS. ONE OF THE HEMORRHAGIC COMPLICATIONS OCCURRED DURING TREATMENT OF A GIANT, MOSTLY THROMBOSED, ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE ENTERPRISE WAS PLACED FROM THE RIGHT A1 SEGMENT TO THE LEFT A2 SEGMENT ACROSS THE NECK OF THE ANEURYSM AFTER A FAILED ATTEMPT TO PLACE A NEUROFORM (ALSO COUNTED AGAINST THE NEUROFORM COHORT). AT THE END OF THE PROCEDURE, A FOCUS OF ACTIVE EXTRAVASATION WAS NOTED FROM THE RIGHT A2 SEGMENT, RESULTING IN SUBARACHNOID AND INTRAVENTRICULAR HEMORRHAGE. IT WAS UNCLEAR WHETHER THIS REPRESENTED A WIRE PERFORATION BECAUSE THE RIGHT A2 WAS NEVER INTENTIONALLY SELECTED. BASELINE LEFT-SIDED WEAKNESS WORSENED TO HEMIPLEGIA AFTER THE PROCEDURE. THE PATIENT WAS DISCHARGED TO AN INPATIENT REHABILITATION CENTER A WEEK LATER. THERE WERE NO PROCEDURAL DEATHS. PER THE ARTICLE, ENTERPRISE STENT DEPLOYMENT SUCCESS WAS HIGH (108 OF 115 ATTEMPTS, 93.9%) WITH 102 ANEURYSMS RECEIVING A STENT. THE COILING MICROCATHETER WAS INSERTED INTO THE ANEURYSM BEFORE STENT DEPLOYMENT IN 70 OF 115 CASES (60.9%); NO STENT MOVEMENT GREATER THAN 1 MM WAS OBSERVED IN THESE CASES. THE JAILING TECHNIQUE, WHICH HAS BEEN USED SINCE THE BEGINNING OF OUR STENT-COILING EXPERIENCE, WAS PREFERENTIALLY USED FOR SMALLER ANEURYSMS, GENERALLY LESS THAN 3¿4 MM IN DIAMETER, CONSIDERED A HIGHER RISK TO CATHETERIZE THROUGH STENT INTERSTICES. TWO PROCEDURES WERE STAGED TO ALLOW ENDOTHELIALIZATION OF THE STENT IN THE SETTING OF PERCEIVED STENT INSTABILITY, AND THE PATIENTS RETURNED AFTER 8 WEEKS FOR COILING IN A DELAYED FASHION THROUGH THE STENT. THREE ENTERPRISE STENTS WERE PLACED TO TACK DOWN COIL TAILS; ONE WAS PLACED TO COVER A STRETCHED COIL. FIVE WERE DEPLOYED AFTER NEUROFORM PLACEMENT FAILED, AND FIVE WERE DEPLOYED THROUGH A PREVIOUSLY PLACED NEUROFORM THAT WOULD NOT RETAIN COILS. NO ADDITIONAL PATIENT, PROCEDURE OR DEVICE INFORMATION WAS PROVIDED FOR THE EVENTS CAPTURED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470489 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| S