BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1871336 · Received October 15, 2010

    Report

    Report Number
    1058196-2010-00294
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    January 8, 2010
    Report Date
    September 20, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMAIL RECEIVED FOR THE (B)(4) STUDY INDICATED THAT DURING THE INDEX PROCEDURE, THE ENTERPRISE STENT MIGRATED, REQUIRING MECHANICAL ACTION. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PATIENT EXPERIENCED VISUAL HALLUCINATIONS DUE TO THE EFFECT OF CONTRAST MATERIAL INJECTED DURING THE PROCEDURE IN THE POSTERIOR FOSSA. NO TREATMENT WAS INDICATED AND MODIFIED RANKIN SCALE WAS 0; UNCHANGED FROM BASELINE. THE PROCEDURE WAS TREATMENT OF AN UNRUPTURED BASILAR TIP ANEURYSM WITH A HEIGHT OF 6MM, SAC WIDTH 5MM AND A 5MM NECK. PARENT VESSEL DIAMETER MEASUREMENTS ARE NOT KNOWN. THE ENTERPRISE WAS PLACED WITH THE DISTAL END IN SEGMENT (B)(6) OF THE LEFT POSTERIOR CEREBRAL ARTERY WHILE THE PROXIMAL PART WAS IN THE BASILAR TRUNK. THE MICROCATHETER FOR COILING WAS PLACED BEFORE THE STENT VIA A JAILING TECHNIQUE. WHILE COILING THE ANEURYSM, AFTER THE DEPLOYMENT OF THE STENT, THE MICROCATHETER WAS PUSHED A LITTLE BIT TO PREVENT IT FROM GETTING OUT OF THE ANEURYSM, AND THE STENT WAS DISPLACED PROXIMALLY; THE DISTAL PART WAS INSIDE THE NECK ANEURYSM WHILE A LITTLE PART OF THE STENT DISTAL END WAS IN (B)(6) SEGMENT. THE ANEURYSM NECK WAS VERY WIDE AND THE STENT DID NOT PROTECT THE COILS TO STAY INSIDE THE ANEURYSM SO A HYPER-FORM 4X7MM BALLOON WAS UTILIZED BETWEEN THE BASILAR TRUNK AND THE RIGHT (B)(6) SEGMENT. POST INDEX PROCEDURE, THE PATIENT EXPERIENCED VISUAL HALLUCINATIONS DUE TO THE EFFECT OF CONTRAST MATERIAL INJECTED DURING THE PROCEDURE IN THE POSTERIOR FOSSA. AN MRI SHOWED NO ISCHEMIA COMPLICATIONS WITH NORMAL PARENCHYMA. THE ENTERPRISE VRD REMAINS IMPLANTED AND THE LOT NUMBER OF THE ENTERPRISE IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. STENT MIGRATION AND NEUROLOGICAL SYMPTOMS ARE KNOWN POSSIBLE ADVERSE EVENTS ASSOCIATED WITH ENTERPRISE ASSISTED COIL EMBOLIZATION PROCEDURES. BASED ON THE AVAILABLE INFORMATION, IT APPEARS THAT PROCEDURAL FACTORS INCLUDING ANEURYSM/VESSEL CHARACTERISTICS AND DEVICE INTERACTION CONTRIBUTED TO THE MOVEMENT OF THE ENTERPRISE VRD AFTER DEPLOYMENT. AND AS REPORTED, THE PHARMACOLOGICAL FACTOR OF CONTRAST INJECTION CONTRIBUTED TO THE NEUROLOGICAL SYMPTOMS. THERE IS NO INDICATION THAT ANY MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE LOCATION OF THE NON-RUPTURED ANEURYSM (B)(4) WAS THE MEDIAL BASILAR T BIFURCATION ARTERY, AND THE ANEURYSM MEASURED (B)(4). THE PATIENT DID NOT HAVE PREVIOUS HISTORY OF SUB-ARACHNOID HEMORRHAGE. THE PRE-PROCEDURE NEUROLOGICAL STATUS WAS ASYMPTOMATIC (B)(4). DURING THE PROCEDURE, A JAILED TECHNIQUE WAS PERFORMED, AND A 22MM ENTERPRISE STENT WAS IMPLANTED AND THE TREATMENT WAS ACHIEVED. ANGIOGRAPHIC RESULTS AFTER THE PROCEDURE REVEALED A RESIDUAL NECK. THE POST-PROCEDURE NEUROLOGICAL STATUS WAS ASYMPTOMATIC (MODIFIED RANKIN SCORE WAS 0). PRE AND POST PROCEDURE THE PATIENT RECEIVED ASPIRIN AND ANTIPLATELET MEDICATION, AND DURING THE PROCEDURE, THE PATIENT RECEIVED HEPARIN. FOLLOW-UP VISIT CONDUCTED APPROXIMATELY TWO MONTHS AFTER THE INDEX PROCEDURE, INDICATED THAT THE NEUROLOGICAL STATUS CONTINUE TO BE ASYMPTOMATIC (MODIFIED RANKIN SCORE WAS 0), WITHOUT ANY COMPLICATIONS OR ADVERSE EVENTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT

    Description of Event or Problem · 1

    THE (B)(4) STUDY (B)(4) STUDY INDICATED THAT FOR PATIENT (B)(4), DURING THE INDEX PROCEDURE THE ENTERPRISE STENT DISTAL PART WAS PLACED IN SEGMENT P1 OF THE LEFT POSTERIOR CEREBRAL ARTERY WHILE THE PROXIMAL PART WAS IN THE BASILAR TRUNK. THE MICROCATHETER WAS PLACED BEFORE THE STENT (JAILING TECHNIQUE). WHILE COILING THE ANEURYSM, AFTER THE DEPLOYMENT OF THE STENT, THE MICROCATHETER WAS PUSHED A LITTLE BIT TO PREVENT IT FROM GETTING OUT OF THE ANEURYSM, AND THE STENT WAS DISPLACED PROXIMALLY, AND THE DISTAL PART WAS INSIDE THE NECK ANEURYSM WHILE A LITTLE PART OF THE STENT DISTAL END WAS IN P 1 SEGMENT. THE ANEURYSM NECK WAS VERY WIDE AND THE STENT DID NOT PROTECT THE COILS TO STAY INSIDE THE ANEURYSM SO A HYPER-FORM 4X7MM BALLOON WAS UTILIZED BETWEEN THE BASILAR TRUNK AND THE RIGHT P1 SEGMENT. POST INDEX PROCEDURE, THE PATIENT EXPERIENCED VISUAL HALLUCINATIONS DUE TO THE EFFECT OF CONTRAST MATERIAL INJECTED DURING THE PROCEDURE IN THE POSTERIOR FOSSA. AN MRI SHOWED NO ISCHEMIA COMPLICATIONS WITH NORMAL PARENCHYMA.

    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. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention| S COILS AND HYPERFORM BALLOON.