BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2023573 · Received March 18, 2011

    Report

    Report Number
    1058196-2011-00109
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    October 14, 2010
    Report Date
    February 24, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: A TOTAL OF 7 COILS WERE USED ORBIT 4MMX10CM, ED COIL 4MMX6CM, 3MMX4CM, 3MMX3CM, 2.5MMX3CM, AND DELTA PLUSH10 2MMX2CM (QTY2). IT WAS INDICATED THAT THERE WERE NO ISSUES DURING THE PROCEDURE WITH ANY OF THE DEVICES OR ANATOMY THAT MAY HAVE CONTRIBUTED TO THE EVENT. ACT WAS NOT PERFORMED. A TOTAL OF 7 COILS WERE USED ORBIT 4MMX10CM, ED COIL 4MMX6CM, 3MMX4CM, 3MMX3CM, 2.5MMX3CM, AND DELTA PLUSH10 2MMX2CM (QTY2). THE CURRENT PATIENT CONDITION WAS STABLE. A CD OF THE PROCEDURE IS NOT AVAILABLE. THE DIAGNOSIS WAS MADE WITH THE AID OF A MRI, AND ANGIOGRAMS BUT THE RESULTS WERE UNKNOWN. THE MODIFIED RANKIN SCORE PRE-PROCEDURE WAS 0, ONE WEEK POST PROCEDURE IT WAS 1 AND 30 DAYS POST PROCEDURE IT WAS 0. THE STENT REMAINS IMPLANTED. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01421602. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. CEREBRAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AND THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. ALTHOUGH BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE, PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DAY OF THE PROCEDURE, THE PATIENT DEVELOPED VRD THROMBOSIS. NO ACTION WAS TAKEN. THE EVENT OUTCOME AS OF 2 DAYS AFTER ONSET WAS RECOVERED WITHOUT SEQUELAE. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE AND TO THE ENTERPRISE WAS ALSO HIGHLY PROBABLE. DURING INITIAL ANGIOGRAMS, FLOW WAS SEEN THROUGHOUT THE TARGET SITE, AND THE ENTERPRISE WAS NOT IMPLANTED WITHIN THROMBUS. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL. THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA THE (B)(4) ENTERPRISE POST MARKET STUDY REPORTING THAT TWO DAYS POST ENTERPRISE VRD ASSISTED ANEURYSM COIL EMBOLIZATION, THE PATIENT HAD AN ASYMPTOMATIC CEREBRAL INFARCTION IN THE BORDER ZONE OF THE STENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT TWO DAYS POST PROCEDURE, THE PATIENT DEVELOPED VRD THROMBOSIS. NO TREATMENT WAS PROVIDED AND THE EVENT OUTCOME TWO DAYS POST EVENT WAS REPORTED AS "RECOVERED WITHOUT SEQUELAE." THE INDEX PROCEDURE WAS TREATMENT OF AN UNRUPTURED SACCULAR PARASELLAR ANEURYSM. THE NECK MEASURED 2.0MM WITH A NECK TO SAC RATIO OF 2.0:3.6. THE PARENT VESSEL MEASURED 2.4MM DISTALLY AND 3.4MM PROXIMALLY. THE ENTERPRISE STENT WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL AFTER INITIAL PLACEMENT. IT WAS REPORTED THAT AT THE TIME OF THE REPORTED EVENT, THE ENTERPRISE STENT WAS FULLY EXPANDED, APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. IT WAS INDICATED THAT THERE WERE NO ISSUES DURING THE PROCEDURE WITH ANY OF THE DEVICES OR ANATOMY THAT MAY HAVE CONTRIBUTED TO THE EVENT AND NO INDICATION OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. ACT WAS NOT PERFORMED DURING THE PROCEDURE AND THERE IS NO INFORMATION REGARDING ANTIPLATELET THERAPY. A TOTAL OF 7 COILS WERE USED ORBIT 4MMX10CM, ED COIL 4MMX6CM, 3MMX4CM, 3MMX3CM, 2.5MMX3CM, AND DELTA PLUSH10 2MMX2CM (QTY2). THE CURRENT PATIENT CONDITION WAS STABLE. A CD OF THE PROCEDURE IS NOT AVAILABLE. THE DIAGNOSIS WAS MADE WITH THE AID OF A MRI, AND ANGIOGRAMS BUT THE RESULTS WERE UNKNOWN. THE MODIFIED RANKIN SCORE PRE-PROCEDURE WAS 0, ONE WEEK POST PROCEDURE IT WAS 1 AND 30 DAYS POST PROCEDURE IT WAS 0. LR PACKAGING L/N# 01421602. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01421602. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. STENT THROMBOSIS AND CEREBRAL INFARCTION 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. ALTHOUGH BASED ON THE LIMITED AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE, PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 01421602

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening