BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6124559 · Received November 23, 2016

    Report

    Report Number
    1226348-2016-00175
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 1, 2016
    Report Date
    November 3, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF ONE INITIAL/FINAL MDR REPORT BEING SUBMITTED WITH ASSOCIATED MFR# 1226348-2016-00175. CATALOG# AND LOT# UNKNOWN, UDI UNAVAILABLE, EXPIRATION DATE UNAVAILABLE. (B)(4). LOT# UNKNOWN, MANUFACTURING DATE UNAVAILABLE. THE PRODUCT WAS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT PROVIDED/KNOWN. PROCEDURAL COMPLICATIONS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD DEVICE AND ARE LISTED IN THE IFU. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE VERY LIMITED INFORMATION SUGGESTS THAT PATIENT, TARGET LESION, INTRAPROCEDURAL AND MEDICATION ISSUES MAY HAVE ALL CONTRIBUTED TO THE UNSPECIFIED COMPLICATIONS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿STENT-ASSISTED COILING OF 501 WIDE-NECKED INTRACRANIAL ANEURYSMS: A SINGLE-CENTER 8 - YEAR EXPERIENCE¿ BY : YONGTAO ZHENG, YANBING SONG, YINGJUN LIU, QIANG XU, YANLONG TIAN, BING LENG. WORLD NEUROSURG. (2016) 94:285-295. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.07.017. DATE OF PUBLICATION: 01-OCT-2016 THE AUTHORS REPORTED THEIR EXPERIENCE WITH STENT-ASSISTED COILING, WITH AN EMPHASIS ON PROCEDURE-RELATED NEUROLOGIC COMPLICATIONS AND THE INCIDENCE OF ANGIOGRAPHIC RECURRENCE. BETWEEN FEBRUARY 2007 AND DECEMBER 2014, 480 PATIENTS WITH 501 ANEURYSMS WERE TREATED WITH STENT-ASSISTED COILING AT THE AUTHOR¿S INSTITUTION. THE COHORT COMPRISED 330 WOMEN (68.75%) AND 150 MEN (31.25%), WITH A MEAN AGE OF 55.4 YEARS (RANGE, 20 - 81YEARS).THREE MAIN TYPES OF STENTS WERE USED TO TREAT WIDE-NECK ANEURYSMS: ENTERPRISE STENTS (CODMAN, RAYNHAM, MASSACHUSETTS, USA), NEUROFORM STENTS (BOSTON SCIENTIFIC/TARGET, FREMONT, CALIFORNIA, USA) AND SOLITAIRE STENTS (COVIDIEN, IRVINE, CALIFORNIA, USA). OTHER TYPES OF STENTS WERE USED IN 20 PATIENTS. AMONG THESE PATIENTS, 423 (88%) WITH 439 ANEURYSMS WERE TREATED ELECTIVELY, AND 57 (12%) WITH 62 ANEURYSMS WERE TREATED IN THE CONTEXT OF SUBARACHNOID HAEMORRHAGE (SAH). THE HUNT AND HESS GRADE WAS I IN 24 PATIENTS, II IN 29 PATIENTS, III IN 6 PATIENTS, AND IV IN 4 PATIENTS. THE MEAN ANEURYSM SIZE WAS 8.6 +/- 4.8 MM (RANGE, 2 - 32 MM). A TOTAL OF 378 ANEURYSMS AROSE FROM THE ANTERIOR CIRCULATION, WHEREAS 123 ANEURYSMS AROSE FROM THE POSTERIOR CIRCULATION. COMPLETE ANGIOGRAPHIC OCCLUSION (100% OCCLUSION) WAS ACHIEVED IN 457 ANEURYSMS. THERE WAS SLIGHT RESIDUAL NECK FILLING (95% - 99% OCCLUSION) IN 21 ANEURYSMS, AND THERE WAS SOME RESIDUAL FILLING IN THE DOMES OF THE ANEURYSM (<95% OCCLUSION) IN 23 ANEURYSMS. THERE WERE 22 OVERALL PROCEDURE-RELATED COMPLICATIONS, CAUSING DEATH IN 4 PATIENTS AND MORBIDITY IN 4 PATIENTS. THESE INCLUDED THROMBOEMBOLIC COMPLICATIONS IN 3 PATIENTS, INCLUDING INTRA-PROCEDURAL THROMBOSIS IN 1 PATIENT; NEW SYMPTOMATIC INFARCTS AFTER THE OPERATION IN 2 PATIENTS; HEMORRHAGIC COMPLICATIONS IN 9 PATIENTS, INCLUDING 4 INTRAPROCEDURAL ANEURYSM RUPTURES AND 5 CASES OF DELAYED INTRACRANIAL HEMORRHAGE (1.04%) AT A MEAN OF 3 DAYS AFTER SURGERY; COIL MIGRATION IN 8 PATIENTS (1.67%); AND DELAYED ISCHEMIC COMPLICATIONS IN 2 PATIENTS BEFORE DISCHARGE. IN A LOGISTIC REGRESSION ANALYSIS, THE COMPLICATIONS DIFFERED SIGNIFICANTLY AMONG THE PATIENTS WITH HYPERTENSION, PATIENTS WITH ANEURYSMS TREATED WITH COILING BEFORE STENTING AND PATIENTS TREATED WITH MULTIPLE STENTS. ANGIOGRAPHIC FOLLOW-UP WAS AVAILABLE FOR 396 PATIENTS FOR A MEAN OF 13 MONTHS. THE RATES OF RECANALIZATION AND RETREATMENT WERE 13.9% AND 3.5%, RESPECTIVELY. IN A LOGISTIC ANALYSIS, LARGER ANEURYSM SIZE AND INITIAL INCOMPLETE ANEURYSM OCCLUSION WERE PREDICTORS OF RECANALIZATION. CLINICAL FOLLOW-UP WAS AVAILABLE FOR 406 PATIENTS (85.6%) FOR A MEAN OF 44.8 MONTHS, AND 399 PATIENTS (98.3%) ACHIEVED A GLASGOW OUTCOME SCALE SCORE OF 5. ENTERPRISE GROUP REPORTED TO HAVE COMPLICATIONS (TABLE# 4) BUT ARTICLE DOES NOT SPECIFIED THE COMPLICATIONS IN EACH GROUP. 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
    774792 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention