BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5781885 · Received July 11, 2016

    Report

    Report Number
    1226348-2016-00118
    Event Type
    Injury
    Date Received
    July 11, 2016
    Date of Event
    February 9, 2016
    Report Date
    June 16, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING LITERATURE ARTICLE IS ATTACHED: SONG, J., SEYANG, OH, KIM, M.J. ET AL, (2016). ¿ENDOVASCULAR TREATMENT OF RUPTURED BLOOD BLISTER-LIKE ANEURYSMS WITH MULTIPLE (=3) OVERLAPPING ENTERPRISE STENTS AND COILING¿ ACTA NEUROCHIR, 158:803¿809, DOI 10.1007/S00701-016-2721-8. THE DATE OF THE EVENT WAS NOT PROVIDED. UDI: THE PRODUCT CODE WAS NOT PROVIDED; THEREFORE THE UDI IS UNKNOWN. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING AND EXPIRATION DATES ARE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: CONCOMITANT DEVICES: ENVOY GUIDE CATHETER, PROWLER SELECT PLUS MICROCATHETER. IMMEDIATELY AFTER THE PROCEDURE, A LOADING DOSE OF ANTIPLATELET MEDICATION (200 MG ASPIRIN AND 300 MG CLOPIDOGREL) WAS GIVEN ORALLY VIA A LEVIN TUBE IN BOTH THE ACUTE AND SUBACUTE SETTINGS. DUAL ANTIPLATELET MEDICATION (100 MG/DAY ASPIRIN AND 75 MG/DAY CLOPIDOGREL) WAS MAINTAINED FOR 3¿6 MONTHS AT THE PHYSICIAN¿S DISCRETION AND THEN WAS CHANGED TO ASPIRIN MONOTHERAPY FOR AN ADDITIONAL 6¿12 MONTHS. CONCLUSION: THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBER COULD NOT BE OBTAINED; THEREFORE, A REVIEW OF MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. STENT THROMBOSIS/OCCLUSION IS A KNOWN ASSOCIATED WITH IMPLANTABLE STENTS AND IS LISTED IN THE INSTRUCTIONS FOR USE. THE EVENT COULD NOT BE CONFIRMED WITHOUT PROCEDURE FILMS TO REVIEW. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED; HOWEVER, PROCEDURAL/PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THE IFU CAUTIONS: ¿THE PERFORMANCE AND SAFETY OF TWO OR MORE OVERLAPPED STENTS HAS NOT BEEN ESTABLISHED¿ AND ¿THE USE OF THE CODMAN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE IN PATIENTS IN WHOM ANTIPLATELET AND/OR ANTICOAGULANT THERAPY IS CONTRAINDICATED COULD RESULT IN A HIGHER RISK OF THROMBOSIS¿. INFORMATION REGARDING THE PATIENT¿S COMPLIANCE WITH ANTIPLATELET MEDICATIONS WAS NOT PROVIDED. THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED TO MAKE A CORRECTION.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿ENDOVASCULAR TREATMENT OF RUPTURED BLOOD BLISTER-LIKE ANEURYSMS WITH MULTIPLE (=3) OVERLAPPING ENTERPRISE STENTS AND COILING¿ PUBLISHED IN ACTA NEUROCHIR (2016) 158:803¿809, IT WAS REPORTED THAT PATIENT # 2, A (B)(6) MALE WHO PRESENTED WITH AN ACUTE CEREBRAL HEMORRHAGE FROM THE 2.5MM X 4.8MM BBA (BLOOD BLISTER LIKE ANEURYSM) IN THE RIGHT ICA (INTERNAL CAROTID ARTERY), EXPERIENCED DIFFUSE IN-STENT THROMBOSIS DURING THE SECOND STENT IMPLANTATION PROCEDURE. THE PATIENT INITIALLY HAD TWO OVERLAPPING 4.5MM X 22MM ENTERPRISE STENTS (CATALOG/LOTS UNKNOWN) AND EMBOLIC COILS IMPLANTED; HOWEVER, AT POST OP DAY 14, ANGIOGRAPHY SHOWED RECANALIZATION OF THE ANEURYSM. ADDITIONAL TREATMENT WAS PERFORMED 1 MONTH LATER BY IMPLANTING TWO 4.5MM X 28MM ENTERPRISE STENTS. DURING THE RE-TREATMENT PROCEDURE, IN-STENT THROMBOSIS WAS NOTED WITHIN THE ENTERPRISE STENTS. THIS WAS TREATED SUCCESSFULLY WITH 1M INTRA-ARTERIAL TIROFIBAN WITHOUT DISTAL EMBOLIZATION OR ADVERSE NEUROLOGIC EVENTS. IMMEDIATELY AFTER THE PROCEDURE, A LOADING DOSE OF ANTIPLATELET MEDICATION (200 MG ASPIRIN AND 300 MG CLOPIDOGREL) WAS GIVEN ORALLY VIA A LEVIN TUBE IN BOTH THE ACUTE AND SUBACUTE SETTINGS. DUAL ANTIPLATELET MEDICATION (100 MG/DAY ASPIRIN AND 75 MG/DAY CLOPIDOGREL) WAS MAINTAINED FOR 3¿6 MONTHS AT THE PHYSICIAN¿S DISCRETION AND THEN WAS CHANGED TO ASPIRIN MONOTHERAPY FOR AN ADDITIONAL 6¿12 MONTHS. NO ADDITIONAL DEVICE, PROCEDURE, OR PATIENT INFORMATION WAS PROVIDED IN THE ARTICLE. THE AIM OF THE STUDY WAS TO EVALUATE THE CLINICAL AND ANGIOGRAPHIC FEASIBILITY OF MULTIPLE OVERLAPPING STENTS (=3) WITH COILING FOR TREATING BBA. A RETROSPECTIVE REVIEW FROM FOUR INSTITUTIONS IDENTIFIED TEN PATIENTS WITH RUPTURED BBAS WHO WERE TREATED WITH MULTIPLE OVERLAPPING STENTS (=3) BETWEEN FEBRUARY 2011 AND JULY 2014. THEY INCLUDED PATIENTS WHO EVENTUALLY HAD MORE THAN THREE STENTS AS INITIAL TREATMENT OR AS A CONSEQUENCE OF RE-TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437235 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention