BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3081756 · Received April 29, 2013

    Report

    Report Number
    1058196-2013-00109
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    August 18, 2011
    Report Date
    April 3, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE (TIA) TRANSIENT ISCHEMIC ATTACK REPORTED RESOLVED WITHOUT RESIDUAL SYMPTOM; HOWEVER, IT IS ALSO REPORTED THAT THERE WERE CONFIRMED SMALL INFARCTS IN THE FRONTAL AND PARIETAL LOBES. HEPARIN WAS ADMINISTERED. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 5.0MM, AND THE NECK TO SAC RATIO WAS 5.0MM:10.1MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.2MM AND DISTALLY WAS 4.1MM. THE MRS WAS 2 PRE, POST PROCEDURE, AND THE ACT WAS 166 SECONDS PRE ANTICOAGULATION BUT POST ANTICOAGULATION UNKNOWN. NO INFORMATION REGARDING THE INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 80% AFTER THE PROCEDURE. DURING THE 1-YEAR FOLLOW-UP ANGIOGRAPHY WAS NOT CONDUCTED. THE MRS WAS 3. THE 2-YEAR FOLLOW-UP ANGIOGRAPHY WAS CONDUCTED, AND IT SHOWED THAT THE SIZE OF BOTH THE ANEURYSM AND THE PARENT VESSEL WERE UNMEASURABLE LEVEL. THE OCCLUSION RATE OF ANEURYSM WAS 83%. MRS WAS 3. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY HAVE BEEN ADMINISTERED CONTINUOUSLY. CLOPIDOGREL SULFATE 75MG/DAY, HEPARIN 10000U & 4000U WAS ADMINISTERED INTRA-PROCEDURALLY. PRIOR TO IMPLANTING THE VRD, A BRITE TIP GUIDING CATHETER (778-280-90/16170895), PROWLER SELECT PLUS (MC) MICROCATHETER (606-S255X/15165078), RADIFOCUS GT 180CM 0.012INCH GUIDEWIRE (TERUMO) WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, EXCELSIOR SL10 TYPE 90 DEGREES AND J MC (STRYKER X2), ORBIT COIL (637CF0824/15129003, 637CF0615/15129002, 637CF0515/15120998), DELTAPLUSH MICROCOIL (CPL100408-30/G11894), DELTAPAQ MICROCOIL (CDF100410-30/G12033 X2, & CDF100310-30/G12087). DURING THE PROCEDURE, JAILED TECHNIQUE WAS UTILIZED. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. PER (B)(4) - (B)(4) MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424292. 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 (B)(4)'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 AND CEREBRAL HEMATOMA ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF INTRACRANIAL STENTS AND COILS AND ARE LISTED IN THE IFU OF THE INVOLVED DEVICES AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR USE, THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND TARGET SITE ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    THE REPORT FROM CLINICAL STUDY "(B)(4) PMS ENTERPRISE" FOR PATIENT WITH ID#(B)(4) INDICATED THAT 23 MONTHS AFTER THE INDEX PROCEDURE WITH AN ENTERPRISE AND CODMAN COILS, SMALL INFARCTS WERE CONFIRMED ON THE LEFT SIDE OF FRONTAL LOBE AND PARIETAL LOBE. HEPARIN WAS ADMINISTERED. THREE DAYS AFTER ONSET, THE PATIENT DEVELOPED RIGHT-SIDED PARALYSIS ASSOCIATED WITH SUB-CORTICAL HEMATOMA. THE CRANIOTOMY FOR REMOVAL OF HEMATOMA WAS PERFORMED. ADDITIONALLY, IT WAS REPORTED THAT DURING A HOSPITALIZATION ANGIOGRAPHIC FOLLOW-UP AT SEVEN MONTHS, THE PATIENT FRACTURED HER RIGHT SHAFT OF FEMUR IN A FALL IN THE HOSPITAL AND DEVELOPED AN ACUTE EPIDURAL HEMATOMA. ACTION TAKEN FOR THE FRACTURE WAS AN ORTHOPEDIC PROCEDURE WHEREAS NO ACTION WAS TAKEN FOR THE ACUTE EPIDURAL HEMATOMA. ALSO, EIGHT MONTHS THE PATIENT'S SYMPTOMS OF DEMENTIA HAD WORSENED. ARICEPT WAS STARTED TO ADMINISTER. THE OUTCOME OF ACUTE EPIDURAL HEMATOMA, FEMORAL FRACTURE, AND OF TRANSIENT ISCHEMIC ATTACK WAS RESOLVED WITHOUT SEQUELAE. ADDITIONALLY, THE OUTCOME OF WORSENING DEMENTIA WAS INDICATED AS "ONGOING, UNCHANGED", AND OF SUBCORTICAL HEMATOMA WAS INDICATED AS "RESOLVED WITH SEQUELAE (RIGHT-SIDED PARALYSIS)." ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF ALL THE EVENTS TO THE PROCEDURE WAS UNRELATED, AND OF FEMORAL FRACTURE, ACUTE EPIDURAL HEMATOMA AND WORSEN DEMENTIA TO THE VRD WAS ALSO UNRELATED, BECAUSE LONG PERIOD HAD ELAPSED AFTER THE INDEX PROCEDURE AND THE PATIENT WAS AN ADVANCED AGE. HOWEVER, THE RELATIONSHIP OF TRANSIENT ISCHEMIC ATTACK, SUBCORTICAL HEMATOMA AND RIGHT-SIDED PARALYSIS TO THE VRD WAS HIGHLY PROBABLE. THE PHYSICIAN COMMENTED THAT SMALL INFARCTS AND HEMATOMA WERE DEVELOPED IN THE AREA PERIPHERAL TO THE VRD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183870 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 01424292

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R