BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5907709 · Received August 26, 2016

    Report

    Report Number
    1226348-2016-00132
    Event Type
    Death
    Date Received
    August 26, 2016
    Date of Event
    April 12, 2016
    Report Date
    August 17, 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

    ARTICLE ATTACHED TO THIS MDR: GE, H., LI, U. , LV, X. (2016). ¿A CHALLENGING ENTITY OF UNRUPTURED GIANT SACCULAR ANEURYSMS OF VERTEBROBASILAR ARTERY¿, NEUROLOGIA I NEUROCHIRURGIA POLSKA, 50 (2016) 236-240, PUBLISHED ONLINE 12APR2016. DOI: 10.1016/J.PJNNS.2016.04.001, THE PRODUCT NUMBER WAS NOT PROVIDED; THEREFORE, UDI IS NOT AVAILABLE. THE CATALOG NUMBER AND LOT NUMBER WAS NOT PROVIDED; THEREFORE THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. THE DATE OF THE EVENT WAS NOT PROVIDED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED 9/19/2016: AFTER COMMUNICATION WITH THE AUTHOR, THE AUTHOR¿S OPINION REGARDING THE CAUSALITY OF THE ADVERSE EVENT IS UNRELATED TO CODMAN ENTERPRISE STENTS. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED. CONCLUSION: IN THE LITERATURE ARTICLE ¿A CHALLENGING ENTITY OF UNRUPTURED GIANT SACCULAR ANEURYSMS OF VERTEBROBASILAR ARTERY¿ BY HUIJIAN GE, YOUXIANG LI, XIANLI LV, PUBLISHED NEUROLOGIA I NEUROCHIRURGIA POLSKA 50 (2016) 236-240, PUBLISHED ONLINE 12APR2016. DOI: 10.1016/J.PJNNS.2016.04.001, THE AUTHORS RETROSPECTIVELY REPORT THE ANGIOGRAPHIC AND CLINICAL PRESENTATIONS IN UNRUPTURED GIANT SACCULAR VERTEBROBASILAR ANEURYSMS WITH AND WITHOUT ENDOVASCULAR TREATMENT. THE AUTHORS FOUND 10 UNRUPTURED GIANT (>25 MM) SACCULAR VERTEBROBASILAR ANEURYSMS OUT OF 400 PATIENTS WHO HAD UNRUPTURED POSTERIOR CIRCULATION ANEURYSMS IN A SINGLE CENTER BETWEEN JANUARY 2008 AND DECEMBER 2014. OF THE 10 GIANT ANEURYSMS IN 10 PATIENTS, THREE WERE LEFT UNTREATED. DURING 6 MONTHS FOLLOW-UP, ALL 3 OF THESE PATIENTS DIED FROM ANEURYSM RUPTURE. THE REMAINING 7 PATIENTS WERE TREATED BY ENDOVASCULAR PROCEDURE, 5 RECEIVED STENT-ASSISTED COILING, 1 WAS TREATED BY PARENT ARTERY OCCLUSION (PAO), AND 1 WAS TREATED BY CONVENTIONAL COILING. OF THESE TREATED PATIENTS, ONLY ONE SURVIVED DURING A 22 MONTH PERIOD OF FOLLOW-UP. AS PER THE ARTICLE, ASE 3, A (B)(6) MALE PATIENT, PRESENTED WITH UNRUPTURED ANEURYSM AT VERTEBROBASILAR JUNCTION OF SIZE 35 X 30MM. PATIENT HAD SYMPTOMS OF ERTIGO, VOMITING, NUMBNESS AND DYSPHAGIA WITH A PRE-ADMISSION MRS SCORE 3. THE PATIENT WAS TREATED WITH AN ENTERPRISE STENT (CATALOG AND LOT NOT IDENTIFIED IN ARTICLE) AND AN UNKNOWN BALLOON. IMMEDIATE POST-PROCEDURAL ANGIOGRAPHY REVEALED PARENT VESSEL OCCLUSION. THE PATIENT EXPIRED ON POST-OPERATIVE DAY 4 DUE TO FAILURE OF COLLATERAL BLOOD FLOW AFTER BILATERAL VERTEBRAL ARTERY OCCLUSION. PATIENTS TREATED WITH STENTS HAD RECEIVED ANTIPLATELET THERAPY (CLOPIDOGREL 75MG AND ASPIRIN 100MG) AT LEAST 5 DAYS BEFORE THE PROCEDURE, RECEIVED 3000 IU OF HEPARIN AT THE BEGINNING OF IMPLANTATION AND 1000 IU INTRAVENOUSLY HOURLY THEREAFTER, AND 75MG CLOPIDOGREL AND 100MG ASPIRIN DAILY AFTER THE PROCEDURE. ACCORDING TO THE AUTHOR, THE EVENT WAS NOT RELATED TO THE CODMAN ENTERPRISE STENT. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. TOTAL OCCLUSION OF TREATED SEGMENT IS A KNOWN POTENTIAL ADVERSE EVENT OF THE ENTERPRISE STENT AND THE CEREBRAL STENTING PROCEDURES. WITHOUT PROCEDURE FILMS, THE EVENT COULD NOT BE CONFIRMED. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, THE AUTHOR REPORTED THAT THE EVENT WAS UNRELATED TO THE ENTERPRISE STENT. THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE, THE AUTHORS RETROSPECTIVELY REPORT THE ANGIOGRAPHIC AND CLINICAL PRESENTATIONS IN UNRUPTURED GIANT SACCULAR VERTEBROBASILAR ANEURYSMS WITH AND WITHOUT ENDOVASCULAR TREATMENT. THE AUTHORS FOUND 10 UNRUPTURED GIANT (>25 MM) SACCULAR VERTEBROBASILAR ANEURYSMS OUT OF 400 PATIENTS WHO HAD UNRUPTURED POSTERIOR CIRCULATION ANEURYSMS BETWEEN JANUARY 2008 AND DECEMBER 2014. OF THE 10 GIANT ANEURYSMS IN 10 PATIENTS, THREE WERE LEFT UNTREATED. DURING 6 MONTHS FOLLOW-UP, ALL 3 OF THESE PATIENTS DIED FROM ANEURYSM RUPTURE. THE REMAINING 7 PATIENTS WERE TREATED BY ENDOVASCULAR PROCEDURE, 5 RECEIVED STENT-ASSISTED COILING, 1 WAS TREATED BY PARENT ARTERY OCCLUSION (PAO), AND 1 WAS TREATED BY CONVENTIONAL COILING. OF THESE TREATED PATIENTS, ONLY ONE SURVIVED DURING A 22 MONTH PERIOD OF FOLLOW-UP. AS PER THE ARTICLE, PATIENT 3, A (B)(6) MALE PATIENT, PRESENTED WITH UNRUPTURED ANEURYSM AT VERTEBROBASILAR JUNCTION OF SIZE 35 X 30MM. PATIENT HAD SYMPTOMS OF VERTIGO, VOMITING, NUMBNESS AND DYSPHAGIA WITH A PRE-ADMISSION MRS SCORE 3. THE PATIENT WAS TREATED WITH AN ENTERPRISE STENT (CATALOG AND LOT NOT IDENTIFIED IN ARTICLE) AND AN UNKNOWN BALLOON. IMMEDIATE POST-PROCEDURAL ANGIOGRAPHY REVEALED PARENT VESSEL OCCLUSION. THE PATIENT EXPIRED ON POST-OPERATIVE DAY 4 DUE TO FAILURE OF COLLATERAL BLOOD FLOW AFTER BILATERAL VERTEBRAL ARTERY OCCLUSION. PATIENTS TREATED WITH STENTS HAD RECEIVED ANTIPLATELET THERAPY (CLOPIDOGREL 75MG AND ASPIRIN 100MG) AT LEAST 5 DAYS BEFORE THE PROCEDURE, RECEIVED 3000 IU OF HEPARIN AT THE BEGINNING OF IMPLANTATION AND 1000 IU INTRAVENOUSLY HOURLY THEREAFTER, AND 75MG CLOPIDOGREL AND 100MG ASPIRIN DAILY AFTER THE PROCEDURE. NO OTHER INFORMATION REGARDING THE DEVICE, PATIENT OR PROCEDURE WERE PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561003 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death