BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3689077 · Received March 19, 2014

    Report

    Report Number
    1058196-2014-00083
    Event Type
    Injury
    Date Received
    March 19, 2014
    Report Date
    February 21, 2014
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF 5 REPORTS SUBMITTED WITH ASSOCIATED MANUFACTURER REPORT NUMBERS: 1058196-2014-00081, 1058196-2014-00082, 1058196-2014-00083, 1058196-2014-00084 AND 1058196-2014-00085.

    Additional Manufacturer Narrative · 1

    (B)(4), THIS IS REPORT 3 OF 4 A LITERATURE ARTICLE (CHO, W.S. ,ET AL. ¿ANGLE CHANGE OF THE PARENT ARTERIES AFTER STENT-ASSISTED COIL EMBOLIZATION OF WIDE-NECKED INTRACRANIAL BIFURCATION ANEURYSMS¿, CLINICAL RADIOLOGY, (2014): 69:E63-E70) REPORTED THAT FOLLOWING IMPLANTATION OF AN ENTERPRISE STENT (CATALOG AND LOT UNKNOWN) DURING STENT ASSISTED COIL EMBOLIZATION (COIL BRAND UNKNOWN) OF WIDE-NECKED INTRACRANIAL BIFURCATING ANEURYSM IN 79 PATIENTS, THERE WAS ONE CASE OF PERMANENT NEUROLOGICAL DEFICIT, SEVEN CASES OF THROMBOEMBOLISM (6 INTRAPROCEDURAL AND 1 DELAYED), THREE CASES OF INTRAPROCEDURAL RUPTURES, THREE CASES OF ASYMPTOMATIC IN-STENT STENOSIS, AND ONE PROXIMAL MIGRATION OF THE STENT . NO ADDITIONAL INFORMATION WAS PROVIDED FOR THE PERMANENT NEUROLOGICAL DEFICIT OR THE STENT MIGRATION. FOR THE SIX INTRAPROCEDURAL THROMBOEMBOLISM CASES, FOUR WERE ASYMPTOMATIC, ONE WAS TRANSIENTLY SYMPTOMATIC, AND ONE WAS PERMANENTLY SYMPTOMATIC. ALL INTRAPROCEDURAL IN-STENT THROMBI WERE COMPLETELY RESOLVED WITH INTRA-ARTERIAL TIROFIBAN INFUSION. THE DELAYED THROMBOEMBOLISM OCCURRED 2 MONTHS AFTER EMBOLIZATION, WHICH WAS RELATED TO POOR COMPLIANCE WITH ANTIPLATELET MEDICATION. ANTIPLATELET MEDICATION HAD INCLUDED A 300MG LOADING DOSE OF CLOPIDOGREL THE DAY BEFORE THE PROCEDURE OR 600MG THE DAY THE PROCEDURE. AFTER THE PROCEDURE, CLOPIDOGREL WAS PRESCRIBED FOR 1 TO 3 MONTHS AND 100MG ASPIRIN WAS MAINTAINED THEREAFTER. SYSTEMIC HEPARIN WAS ADMINISTERED DURING THE PROCEDURE WITH 3000 IU IV BOLUS FOLLOWED BY AN ADDITIONAL 100 IU INJECTION PER HOUR. ONE OF THE THREE CASES OF INTRAPROCEDURAL RUPTURE RESULTED IN TRANSIENT NAUSEA, WHILE THE OTHER 2 COMPLETELY RECOVERED WITHOUT ANY NEUROLOGICAL DEFICITS. ALL THREE RESTENOSIS WERE <50%. THERE WAS NO INFORMATION PROVIDED IN THE ARTICLE TO DESCRIBE DETAILS OF ANY INDIVIDUAL PATIENT OR PROCEDURE. NO STERILE LOT NUMBERS WERE REPORTED, THUS NO DHRS COULD BE PERFORMED. STENT MIGRATION, RUPTURED CEREBRAL ANEURYSM, THROMBOSIS AND PERMANENT NEUROLOGIC IMPAIRMENTS ARE ALL KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH INTRA-CEREBRAL STENT PLACEMENT PROCEDURES. 100% INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT PROCEDURAL, TARGET AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(6). THIS IS REPORT 3 OF 5.

    Description of Event or Problem · 1

    A LITERATURE ARTICLE (CHO, W.S. ,ET AL. ¿ANGLE CHANGE OF THE PARENT ARTERIES AFTER STENT-ASSISTED COIL EMBOLIZATION OF WIDE-NECKED INTRACRANIAL BIFURCATION ANEURYSMS¿, CLINICAL RADIOLOGY, (2014): 69:E63-E70) REPORTED THAT FOLLOWING IMPLANTATION OF AN ENTERPRISE STENT (CATALOG AND LOT UNKNOWN) DURING STENT ASSISTED COIL EMBOLIZATION (COIL BRAND UNKNOWN) OF WIDE-NECKED INTRACRANIAL BIFURCATING ANEURYSM IN 79 PATIENTS, THERE WAS ONE CASE OF PERMANENT NEUROLOGICAL DEFICIT, SEVEN CASES OF THROMBOEMBOLISM (6 INTRAPROCEDURAL AND 1 DELAYED), THREE CASES OF INTRAPROCEDURAL RUPTURES, THREE CASES OF ASYMPTOMATIC IN-STENT RESTENOSIS, AND ONE PROXIMAL MIGRATION OF THE STENT . NO ADDITIONAL INFORMATION WAS PROVIDED FOR THE PERMANENT NEUROLOGICAL DEFICIT OR THE STENT MIGRATION. FOR THE SIX INTRAPROCEDURAL THROMBOEMBOLISM CASES , FOUR WERE ASYMPTOMATIC, ONE WAS TRANSIENTLY SYMPTOMATIC, AND ONE WAS PERMANENTLY SYMPTOMATIC. ALL INTRAPROCEDURAL IN-STENT THROMBI WERE COMPLETELY RESOLVED WITH INTRA-ARTERIAL TIROFIBAN INFUSION. THE DELAYED THROMBOEMBOLISM OCCURRED 2 MONTHS AFTER EMBOLIZATION, WHICH WAS RELATED TO POOR COMPLIANCE WITH ANTIPLATELET MEDICATION. ANTIPLATELET MEDICATION HAD INCLUDED A 300MG LOADING DOSE OF CLOPIDOGREL THE DAY BEFORE THE PROCEDURE OR 600MG THE DAY THE PROCEDURE. AFTER THE PROCEDURE, CLOPIDOGREL WAS PRESCRIBED FOR 1 TO 3 MONTHS AND 100MG ASPIRIN WAS MAINTAINED THEREAFTER. SYSTEMIC HEPARIN WAS ADMINISTERED DURING THE PROCEDURE WITH 3000 IU IV BOLUS FOLLOWED BY AN ADDITIONAL 100 IU INJECTION PER HOUR. ONE OF THE THREE CASES OF INTRAPROCEDURAL RUPTURE RESULTED IN TRANSIENT NAUSEA, WHILE THE OTHER 2 COMPLETELY RECOVERED WITHOUT ANY NEUROLOGICAL DEFICITS. ALL THREE RESTENOSIS WERE <50%. THERE WAS NO INFORMATION PROVIDED IN THE ARTICLE TO DESCRIBE DETAILS OF ANY INDIVIDUAL PATIENT OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162472 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention