BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6417044 · Received March 20, 2017

    Report

    Report Number
    1226348-2017-00041
    Event Type
    Injury
    Date Received
    March 20, 2017
    Date of Event
    April 23, 2016
    Report Date
    February 23, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICES WERE NOT RETURNED FOR ANALYSIS. IN ADDITION, THE LOT NUMBERS WERE NOT PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. STROKE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF THE ENTERPRISE STENT AND THE IMPLANTATION PROCEDURE. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE CEREBELLAR INFARCTIONS. THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WERE RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE FOLLOWING LITERATURE ARTICLE IS ATTACHED TO THIS MDR REPORT: JEON, J.P., CHO, Y.D., RHIM, J.K, ET AL. (2016). STENT-ASSISTED COIL EMBOLIZATION OF VERTEBROBASILAR DISSECTING ANEURYSMS: PROCEDURAL OUTCOMES AND FACTORS FOR RECANALIZATION. NEUROINTERVENTION, HTTP://DX.DOI.ORG/10.3348/KJR.2016.17.5.801. UDI: UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE. SINCE THE LOT NUMBER WAS NOT PROVIDED, DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. THE DATE OF THE EVENTS WAS ALSO UNKNOWN. THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THERE WERE 3 PATIENTS/PROCEDURES ASSOCIATED WITH THIS MDR; HOWEVER, SINCE THERE WAS NOT DEVICE, PATIENT, OR PROCEDURE SPECIFIC INFORMATION AVAILABLE, ALL THREE EVENTS WERE REPORTED UNDER THIS SINGLE MDR REPORT. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿STENT-ASSISTED COIL EMBOLIZATION OF VERTEBROBASILAR DISSECTING ANEURYSMS: PROCEDURAL OUTCOMES AND FACTORS FOR RECANALIZATION¿ BY JIN PYEONG JEON, MD, YOUNG DAE CHO, MD, JONG KOOK RHIM, MD, JEONG JIN PARK, MD,WON-SANG CHO, MD, HYUN-SEUNG KANG, MD, JEONG EUN KIM, MD, GYOJUN HWANG, MD,O-KI KWON, MD, AND MOON HEE HAN, MD, PUBLISHED NEUROINTERVENTION, HTTP://DX.DOI.ORG/10.3348/KJR.2016.17.5.801, IT WAS REPORTED THAT AFTER IMPLANTATION OF ENTERPRISE STENTS (CATALOG/LOT UNKNOWN), THREE PATIENTS EXPERIENCED CEREBELLAR INFARCTIONS ON POST-EMBOLIZATION DAY 1, WEEK 2, AND MONTH 2, RESPECTIVELY, BUT NO OTHER PROCEDURE-RELATED COMPLICATIONS DEVELOPED. THE ARTICLE PROVIDED NO PATIENT, PROCEDURE, OR DEVICE SPECIFIC INFORMATION. PER THE ARTICLE: ¿OUTCOMES OF STENT-ASSISTED COIL EMBOLIZATION (SACE) HAVE NOT BEEN WELL ESTABLISHED IN THE SETTING OF VERTEBROBASILAR DISSECTING ANEURYSMS (VBDAS) DUE TO THE LOW PERCENTAGE OF CASES THAT NEED TREATMENT AND THE ARRAY OF AVAILABLE THERAPEUTIC OPTIONS. HEREIN, WE PRESENTED CLINICAL AND RADIOGRAPHIC RESULTS OF SACE IN PATIENTS WITH VBDAS¿ STENT-ASSISTED COIL EMBOLIZATION TECHNICALLY SUCCEEDED IN ALL PATIENTS. IMMEDIATELY FOLLOWING SACE, 25 ANEURYSMS (53.2%) SHOWED NO CONTRAST FILLING INTO THE ANEURYSMAL SAC. DURING A MEAN FOLLOW-UP OF 20.2 MONTHS, 37 LESIONS (78.7%) APPEARED COMPLETELY OCCLUDED, WHEREAS 10 LESIONS SHOWED RECANALIZATION, 5 OF WHICH REQUIRED ADDITIONAL EMBOLIZATION. OVERALL RECANALIZATION RATE WAS 12.64% PER LESION-YEAR, AND MEAN POSTOPERATIVE TIME TO RECANALIZATION WAS 18 MONTHS (RANGE, 3¿36 MONTHS). IN MULTIVARIABLE ANALYSIS, MAJOR BRANCH INVOLVEMENT (HAZARD RATIO [HR]: 7.28; P = 0.013) AND THE PRESENCE OF RESIDUAL SAC FILLING (HR: 8.49, P = 0.044) WERE IDENTIFIED AS STATISTICALLY SIGNIFICANT INDEPENDENT PREDICTORS OF RECANALIZATION. NO BLEEDING WAS ENCOUNTERED IN FOLLOW-UP MONITORING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200314 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