BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6713467 · Received July 14, 2017

    Report

    Report Number
    1226348-2017-00120
    Event Type
    Injury
    Date Received
    July 14, 2017
    Date of Event
    March 5, 2015
    Report Date
    July 3, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MDR IS TO REPORT 3 UNSPECIFIED ENTERPRISE DEVICES. NO ADDITIONAL INFORMATION COULD BE PROVIDED BY THE AUTHOR, INCLUDING LOT AND CATALOG NUMBERS. 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. ARTICLE ATTACHED TO THIS MDR. BHOGAL, P., BROUWER, P.A., SÖDERQVIST, A.K., ET AL, (2015). PATIENTS WITH SUBARACHNOID HAEMORRHAGE FROM VERTEBROBASILAR DISSECTION: TREATMENT WITH STENT-IN-STENT TECHNIQUE. NEURORADIOLOGY (2015) 57:605¿614 DOI 10.1007/S00234-015-1505-9. COMPLAINTS FOR 4 EVENTS DESCRIBED IN THE ARTICLE ARE BEING SUBMITTED IN SEPARATE MDR REPORTS. 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. CONCLUSION: THE DEVICES WERE NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBERS WERE NOT PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. PSEUDOANEURYSM AND DISSECTION ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH IMPLANTATION OF ENTERPRISE STENTS. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED BASED ON THE INFORMATION PROVIDED; HOWEVER, OFF-LABEL USE OF THE ENTERPRISE STENTS MAY HAVE CONTRIBUTED TO THE EVENT. PER THE INSTRUCTIONS FOR USE (IFU): ¿THE CODMAN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM IS NOT INTENDED FOR USE AS A STAND-ALONE DEVICE, I.E. WITHOUT SUBSEQUENT COIL EMBOLIZATION OF THE ANEURYSM.¿ THE IFU ALSO CAUTIONS: ¿THE PERFORMANCE AND SAFETY OF TWO OR MORE OVERLAPPING STENTS HAS NOT BEEN ESTABLISHED¿. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE IS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿PATIENTS WITH SUBARACHNOID HAEMORRHAGE FROM VERTEBROBASILAR DISSECTION: TREATMENT WITH STENT-IN-STENT TECHNIQUE¿ BY BHOGAL, P., BROUWER, P.A., SÖDERQVIST, A.K., ET AL, PUBLISHED NEURORADIOLOGY (2015) 57:605¿614 DOI 10.1007/S00234-015-1505-9. A (B)(6) MALE PATIENT HAD AN ENLARGING PSEUDOANEURYSM POST TREATMENT WITH THREE ENTERPRISE STENTS (CATALOG AND LOT NUMBERS NOT PROVIDED IN THE ARTICLE OR AVAILABLE FROM THE AUTHOR). PATIENT 10 PRESENTED WITH A SUBARACHNOID HEMORRHAGE AND RIGHT VERTEBRAL AND PICA DISSECTION ARISING FROM THE SITE OF PSEUDOANEURYSM. IN THIS PATIENT, THREE ADDITIONAL STENTS WERE PLACED ACROSS THE SITE OF DISSECTION 15 DAYS AFTER THE ORIGINAL PROCEDURE. THIS RESULTED IN SIX STENTS IN TOTAL. PATIENT SHOWED ENLARGEMENT OF THE PSEUDOANEURYSM ON EARLY FOLLOW-UP CT ANGIOGRAPHY. THERE WAS RESOLUTION OF THE ANEURYSM ON THE DELAYED CT ANGIOGRAPHY PERFORMED AT 23 MONTHS. THE OBJECTIVE OF THE STUDY DESCRIBED IN THE ARTICLE WAS TO ANALYZE IF A STENT-IN-STENT TREATMENT WAS EFFECTIVE TREATMENT IN PATIENTS WITH SUBARACHNOID HEMORRHAGE FROM VERTEBROBASILAR DISSECTION. NINETY-THREE PATIENTS WITH POTENTIAL SUBARACHNOID HEMORRHAGE SECONDARY TO VERTEBROBASILAR PATHOLOGY WERE IDENTIFIED. AFTER REVIEW OF THE CLINICAL NOTES AND IMAGING, 15 WERE FOUND TO HAVE PRESENTED WITH SUBARACHNOID HEMORRHAGE AND TREATED WITH STENTS ALONE. ALL DISSECTIONS WERE SPONTANEOUS WITH NO HISTORY OF PRECEDING TRAUMA. THE AGES RANGED BETWEEN 46 AND 71 YEARS (MEAN 61 YEARS). ALL PATIENTS PRESENTED WITH FISCHER GRADE 4 SAH AND HAD A VISIBLE PSEUDOANEURYSM. ALL PATIENTS WERE TREATED WITH A BOLUS OF IV HEPARIN 5000 IU AND 100IU PER HOUR TO MAINTAIN THE ACTIVATED CLOTTING TIME (ACT) AT APPROXIMATELY 2 -2.5 TIMES ABOVE NORMAL. A VARIETY OF STENTS WERE USED INCLUDING ENTERPRISE, WINGSPAN, NEUROFORM, SURPASS, LVIS AND LVIS JR. NO INTRA-PROCEDURAL COMPLICATIONS WERE EXPERIENCED. THE AUTHORS CONCLUDED THAT STENT-IN-STENT TECHNIQUE REPRESENTED A VIABLE RECONSTRUCTIVE ENDOVASCULAR SURGICAL TECHNIQUE WITH LOW RISK OF INTRA-PROCEDURAL COMPLICATIONS AND POST-OPERATIVE REPEAT HEMORRHAGE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494162 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R