BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3100536 · Received May 8, 2013

    Report

    Report Number
    1058196-2013-00123
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 24, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN A PUBLISHED ARTICLE WAKHLOO, A.J., ET ALL ¿CLOSED-CELL STENT FOR COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS: CLINICAL AND ANGIOGRAPHIC RESULTS¿ AJNR 33:1651-56, OCT. 2012 EVALUATED THE SAFETY AND EFFICACY OF CLOSED-CELL STENT ASSISTED COIL EMBOLIZATION (SACE). INTRAPROCEDURAL CLOT FORMATION ON THE SURFACE OF THE STENT WAS OBSERVED IN 11 CASES, ALL OF WHICH WERE SUCCESSFULLY TREATED WITH INTRA-ARTERIAL ADMINISTRATION OF ABCIXIMAB. THERE WERE 5 MINOR AND 3 MAJOR STROKES WITHIN 30 DAYS OF THE PROCEDURE. ONE PATIENT DEATH RELATED TO THROMBOEMBOLISM AND ONE STROKE RESULTING IN DEATH SIX MONTHS POST PROCEDURE. SIX PATIENTS EXPERIENCED A TRANSIENT ISCHEMIC ATTACK. INTIMAL HYPERPLASIA PRODUCED ASYMPTOMATIC MILD (<20%) NARROWING IN 6 PATIENTS AND MODERATE ASYMPTOMATIC NARROWING (>20%;<70%) IN 1 PATIENT. TWO OF THE MILD AND ONE MODERATE CASE OF IN-STENT STENOSIS INVOLVED STENTED SEGMENT IN VESSELS MEASURING LESS THAN 2MM, WHICH IS LESS THAN THE MINIMUM VESSEL DIAMETER FOR USE OF THE ENTERPRISE VRD AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE ARTICLE FURTHER OUTLINES THE NUMBER OF PATIENTS BY CHANGE IN MODIFIED RANKIN SCORE (MRS) FROM BASELINE AND DESCRIPTION OF NEUROLOGICAL SYMPTOMS. FOR THE TREATED UNRUPTURED ANEURYSMS THE CHANGE IN MRS OF 1 POINT WERE LISTED AS NEW OR MORE SEVERE HEADACHE (4), MILD EXTREMITY WEAKNESS (3) MILD VISUAL FIELD DEFICIT (1). THERE WAS CHANGE IN MRS OF 2 IN ONE PATIENT WITH STROKE AFTER TERMINATION OF ANTIPLATELET THERAPY 60 DAYS POST PROCEDURE, CHANGE IN MRS OF 3 WITH ANTERIOR CHOROIDAL ARTERY STROKE (1), STROKE AFTER TERMINATION OF ANTIPLATELET THERAPY 10 MONTHS POST TREATMENT AND 2 DEATHS OF PATIENTS WITH UNRUPTURED ANEURYSM 1 WITH SNEDDON SYNDROME WITH WITHDRAWAL OF CARE AFTER THROMBOEMBOLISM, AND ONE STROKE SIX MONTHS AFTER TREATMENT. ONE STROKE DUE TO STENT OCCLUSION AFTER STOPPING ANTIPLATELET THERAPY FOR SHUNT PLACEMENT IN TREATMENT OF A PRESENTING RUPTURED ANEURYSM RESULTED IN AN INCREASE IN MRS OF 2. THE DEMOGRAPHICS AND ANEURYSM INFORMATION IS LISTED IN A TABLE WITHOUT CORRELATION TO THE SPECIFIC EVENTS. ONE HUNDRED SIXTY ONE (161) ANEURYSMS IN 147 PATIENTS WERE TREATED AT TWO CENTERS BETWEEN (B)(6) 2007 AND (B)(6) 2010. EIGHTEEN (18) WERE TREATED ACUTELY FOLLOWING RUPTURE. IN TWO CASES OF SMALL ANEURYSM AND DISSECTING ANEURYSM, NO COILS WERE USED IN CONJUNCTION WITH THE STENT. IT IS LISTED IN THE IFU PRECAUTIONS THAT THE ENTERPRISE VRD IS NOT INTENDED FOR USE AS A STAND-ALONE DEVICE, I.E. WITHOUT SUBSEQUENT COIL EMBOLIZATION OF THE ANEURYSM. IN 2 CASES THE STENT WAS RESHEATHED FOLLOWING SUCCESSFUL COIL EMBOLIZATION BY THE SEMI-JAILED TECHNIQUE. 2 OF THE STENTED VESSELS MEASURED LESS THAN 2MM. PATIENTS WERE GIVEN ASA (80MG) AND CLOPIDOGREL (75MG) FOR A MINIMUM OF 3 DAYS BEFORE THE PROCEDURE. DUAL ANTIPLATELET THERAPY WAS CONTINUED FOR A MINIMUM OF 6 MONTHS FOLLOWED BY LIFE-LONG CONTINUATION OF ASA. IN CASES OF ACUTE ANEURYSM RUPTURE CASES, THE NEED FOR VENTRICULOSTOMY BEFORE ADMINISTERING ANTIPLATELET THERAPY WAS ASSESSED. IT WAS REPORTED THAT POOR OUTCOMES WERE MOSTLY RELATED TO THROMBOEMBOLIC COMPLICATIONS ASSOCIATED WITH PREMATURE TERMINATION OF SYSTEMIC DUAL-ANTIPLATELET THERAPY RATHER THAN THE SACE PROCEDURE. WITH FOLLOW-UP INVESTIGATION IT WAS REPORTED THAT NO FURTHER CASE SPECIFIC INFORMATION IS AVAILABLE. SOME OF THE EVENTS ARE RELATED TO EARLY TERMINATION OF ANTIPLATELET AGENTS AND POTENTIAL INSUFFICIENT PLATELET INHIBITION. THUS, THE AUTHOR REPORTS RECENTLY HAVING INTRODUCED PRIOR TO PLACEMENT OF STENTS, EVALUATION OF ANTIPLATELET INHIBITION USING THE VERIFY NOW SYSTEM. THROMBOSIS AND STROKE AND TIAS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AND THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. AS REPORTED SOME OF THE EVENTS ARE RELATED TO EARLY TERMINATION OR INSUFFICIENT RESPONSE TO ANTIPLATELET THERAPY. THE AUTHORS CONCLUDE THAT THIS SERIES ADDS TO THE EVIDENCE DEMONSTRATING THE SAFETY AND EFFECTIVENESS OF SACE IN THE TREATMENT OF INTRACRANIAL ANEURYSMS. HOWEVER, SACE OF RUPTURED ANEURYSMS AND PREMATURE TERMINATION OF ANTIPLATELET TREATMENT ARE ASSOCIATED WITH INCREASED MORBIDITY AND MORTALITY. THE IFU OUTLINES THAT THE ENTERPRISE VRD IS GENERALLY CONTRAINDICATED IN PATIENTS IN WHOM ANTIPLATELET AND/OR ANTICOAGULATION THERAPY IS CONTRAINDICATED. AS CITED IN THE INSTRUCTIONS FOR USE, STENOSIS OF THE STENTED ARTERY SEGMENT IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH INTRACRANIAL STENT PLACEMENT. THREE OF THE EVENTS OCCURRED IN VESSELS THAT WERE LESS THAN THE MINIMUM VESSEL DIAMETER FOR USE OF THE ENTERPRISE VRD AS OUTLINED IN THE IFU. UNDERLYING PATIENT AND PROCEDURAL FACTORS MAY PLAY A ROLE IN THE INTIMAL HYPERPLASIA; HOWEVER, BASED ON THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE REGARDING THE EVENTS. ALTHOUGH DEFINITIVE ROOT CAUSE CONCLUSIONS CANNOT BE DETERMINED FOR THE REPORTED EVENTS, THERE IS NO INDICATION OF ANY RELATED DEVICE PERFORMANCE OR MANUFACTURING ISSUES WITH CLINICAL, PATIENT, AND PHARMACOLOGICAL FACTORS POSSIBLY IMPACTING THE EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE ARTICLE FURTHER OUTLINES THE NUMBER OF PATIENTS BY CHANGE IN MODIFIED RANKIN SCORE (MRS) FROM BASELINE AND DESCRIPTION OF NEUROLOGICAL SYMPTOMS. FOR THE TREATED UNRUPTURED ANEURYSMS THE CHANGE IN MRS OF 1 POINT WERE LISTED AS NEW OR MORE SEVERE HEADACHE (4), MILD EXTREMITY WEAKNESS (3) MILD VISUAL FIELD DEFICIT (1). THERE WAS CHANGE IN MRS OF 2 IN ONE PATIENT WITH STROKE AFTER TERMINATION OF ANTIPLATELET THERAPY 60 DAYS POST PROCEDURE, CHANGE IN MRS OF 3 WITH ANTERIOR CHOROIDAL ARTERY STROKE (1), STROKE AFTER TERMINATION OF ANTIPLATELET THERAPY 10 MONTHS POST TREATMENT AND 2 DEATHS OF PATIENTS WITH UNRUPTURED ANEURYSM 1 WITH SNEDDON SYNDROME WITH WITHDRAWAL OF CARE AFTER THROMBOEMBOLISM, AND ONE STROKE SIX MONTHS AFTER TREATMENT. ONE STROKE DUE TO STENT OCCLUSION AFTER STOPPING ANTIPLATELET THERAPY FOR SHUNT PLACEMENT IN TREATMENT OF A PRESENTING RUPTURED ANEURYSM RESULTED IN AN INCREASE IN MRS OF 2. THE DEMOGRAPHICS AND ANEURYSM INFORMATION IS LISTED IN A TABLE WITHOUT CORRELATION TO THE SPECIFIC EVENTS: 161 ANEURYSMS IN 147 PATIENTS WERE TREATED AT TWO CENTERS BETWEEN JUNE 2007 AND JUNE 2010; 18 WERE TREATED ACUTELY FOLLOWING RUPTURE. IN TWO CASES OF SMALL ANEURYSM AND DISSECTING ANEURYSM, NO COILS WERE USED IN CONJUNCTION WITH THE STENT. IN 2 CASES THE STENT WAS RESHEATHED FOLLOWING SUCCESSFUL COIL EMBOLIZATION BY THE SEMI-JAILED TECHNIQUE. IN 2 OF THE STENTED VESSELS MEASURED LESS THAN 2MM. PATIENTS WERE GIVEN ASA (80MG) AND CLOPIDOGREL (75MG) FOR A MINIMUM OF 3 DAYS BEFORE THE PROCEDURE. DUAL ANTIPLATELET THERAPY WAS CONTINUED FOR A MINIMUM OF 6 MONTHS FOLLOWED BY LIFE-LONG CONTINUATION OF ASA. IN CASES OF ACUTE ANEURYSM RUPTURE CASES, THE NEED FOR VENTRICULOSTOMY BEFORE ADMINISTERING ANTIPLATELET THERAPY WAS ASSESSED. IT WAS REPORTED THAT POOR OUTCOMES WERE MOSTLY RELATED TO THROMBOEMBOLIC COMPLICATIONS ASSOCIATED WITH PREMATURE TERMINATION OF SYSTEMIC DUAL-ANTIPLATELET THERAPY RATHER THAN THE SACE PROCEDURE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    IN A PUBLISHED ARTICLE WAKHLOO, A.J., ET ALL "CLOSED-CELL STENT FOR COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS: CLINICAL AND ANGIOGRAPHIC RESULTS" AJNR 33:1651-56, OCT. 2012 EVALUATED THE SAFETY AND EFFICACY OF CLOSED-CELL STENT ASSISTED COIL EMBOLIZATION (SACE). INTRAPROCEDURAL CLOT FORMATION ON THE SURFACE OF THE STENT WAS OBSERVED IN 11 CASES, ALL OF WHICH WERE SUCCESSFULLY TREATED WITH INTRA-ARTERIAL ADMINISTRATION OF ABCIXIMAB. THERE WERE 5 MINOR AND 3 MAJOR STROKES WITHIN 30 DAYS OF THE PROCEDURE. ONE PATIENT DEATH RELATED TO THROMBOEMBOLISM AND ONE STROKE RESULTING IN DEATH SIX MONTHS POST PROCEDURE. SIX PATIENTS EXPERIENCED A TRANSIENT ISCHEMIC ATTACK. INTIMAL HYPERPLASIA PRODUCED ASYMPTOMATIC MILD (<20%) NARROWING IN 6 PATIENTS AND MODERATE ASYMPTOMATIC NARROWING (>20%;<70%) IN 1 PATIENT. TWO OF THE MILD AND ONE MODERATE CASE OF IN-STENT STENOSIS INVOLVED STENTED SEGMENT IN VESSELS MEASURING LESS THAN 2MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200382 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1