BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2073369 · Received May 1, 2011

    Report

    Report Number
    1058196-2011-00192
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    February 10, 2011
    Report Date
    April 19, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED VIA THE (B)(4) POST MARKET SURVEILLANCE THAT THE PATIENT DEVELOPED A STROKE (INFARCTION) IN THE RIGHT BRAIN AN HOUR AFTER AN ENTERPRISE VRD (ENC452212) ASSISTED COIL EMBOLIZATION OF A PARTIALLY THROMBOSED ANEURYSM. TEN ORBIT TDL COILS, 20 ORBIT COMPLEX FILL COILS AND 12 GALAXY COILS, 7 HYDROCOILS (MICROVENTION) WERE USED TO FILL THE ANEURYSM. THE PATIENT HAD HEMIPLEGIA (LEFT UPPER LIMB) AND SPACIAL NEGLECT WAS NOTED. DRUG THERAPY WAS DONE WITH RADICUT, ARGATROBAN AND HEPARIN. RECOVERY WAS CONFIRMED. THE PHYSICIAN COMMENTED THE THROMBUS MIGHT HAVE COME OUT OF THE ANEURYSM. THE TARGET SITE WAS A SACCULAR RIGHT PARASELLAR ANEURYSM WITH A 7.0MM NECK WITH A NECK TO SAC RATIO OF 7.0MM TO 9.7MM. THE PARENT VESSEL DIAMETER WAS 4.4MM AND 3.8MM DISTALLY. THE RECOMMENDED PARENT VESSEL DIAMETER FOR USE OF THE ENTERPRISE VRD AS OUTLINED IN THE INSTRUCTIONS FOR USE IS 2.5MM - 4.0MM. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSED TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THE ENTERPRISE WAS FULLY EXPANDED, APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. INTRAPROCEDURAL HEPARIN WAS ADMINISTERED. THE PRE-PROCEDURE ACT WAS 144 SECONDS, AND POST-PROCEDURE WAS 266 SECONDS. THE MODIFIED RANKIN SCALE PRE-PROCEDURE WAS 3, POST (WITHIN A WEEK) WAS 4, AND POST (AFTER 30 DAYS) WAS 3. ANTIPLATELET THERAPY INCLUDED PLAVIX 75MG/DAY STARTING ONE WEEK PRIOR TO PROCEDURE UNTIL THREE WEEKS POST PROCEDURE AT WHICH TIME IT WAS CHANGED TO CILOSTAZOL 100MG/DAY. PROCEDURAL IMAGES ARE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15114889 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. CEREBRAL INFARCTION/STROKE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AND COIL EMBOLIZATION PROCEDURES AS OUTLINED IN THE INSTRUCTIONS FOR USE. DURING INTERVENTIONAL PROCEDURES, THE DEVICES ARE ADVANCED AND WITHDRAWN THROUGH ACCESSORY ARTERIES TO TREAT THE TARGET LESION. THE PHYSICAL MANIPULATION OF THE ARTERIES AND IN THIS CASE, THE PRE-EXISTING PRESENCE OF THROMBUS IN THE ANEURYSM MAY RESULT IN EMBOLIZATION FROM THE TREATMENT SITE. IT APPEARS THAT CLINICAL FACTORS CONTRIBUTED TO THE EVENT WITH NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS TWO OF MULTIPLE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00191, 1058196-2011-00192, 1058196-2011-00193, 3007628272-2011-50011, 1058196-2011-00255, 1058196-2011-00256, 1058196-2011-00257, 1058196-2011-00258, 1058196-2011-00259, 1058196-2011-00260, 1058196-2011-00261, 1058196-2011-00262, 1058196-2011-00263, 1058196-2011-00264, 1058196-2011-00265, 1058196-2011-00266, 3007628272-2011-50013, AND 3007628272-2011-50014.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PROWLER SELECT PLUS MICROCATHETER, ROAD MASTER 7FRENCH GUIDING CATHETER, EXCELSIOR SL10 MICROCATHETER, CHIKAI GUIDEWIRE, ORBIT TDL (QTY 10), ORBIT COMPLEX FILL (QTY 20), HYDRO COIL (QTY 7), AND GALAXY COILS (QTY 12). THE PRE-PROCEDURE ACT WAS 144 SECONDS, AND POST-PROCEDURE WAS 266 SECONDS. MEDICATIONS CONSISTED OF PLAVIX 75MG/DAY (B)(6), HEPARIN (INTRA-PROCEDURE), AND CILOSTAZOL 100MG/DAY (B)(6). THE SACCULAR ANEURYSM MEASURED AT THE NECK WAS 7.0MM AND THE NECK TO SAC RATIO WAS 7.0MM/9.7MM. THE TARGET SITE WAS THE RIGHT PARASELLAR WITH A VESSEL DIAMETER PROXIMALLY 4.4MM AND DISTALLY 3.8MM. A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE. THE LOT NUMBERS OF THE COILS ARE NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. CEREBRAL INFARCTION/STROKE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AND COIL EMBOLIZATION PROCEDURES AS OUTLINED IN THE INSTRUCTIONS FOR USE. DURING INTERVENTIONAL PROCEDURES, THE DEVICES ARE ADVANCED AND WITHDRAWN THROUGH ACCESSORY ARTERIES TO TREAT THE TARGET LESION. THE PHYSICAL MANIPULATION OF THE ARTERIES AND IN THIS CASE, THE PRE-EXISTING PRESENCE OF THROMBUS IN THE ANEURYSM MAY RESULT IN EMBOLIZATION FROM THE TREATMENT SITE. IT APPEARS THAT CLINICAL FACTORS CONTRIBUTED TO THE EVENT WITH NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE: THE CATALOG AND LOT NUMBER/(S) FOR THE ACTUAL PRODUCT/(S) USED IN THE PROCEDURE ARE UNKNOWN. THIS IS TEN OF MULTIPLE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00191, 1058196-2011-00192, 1058196-2011-00193, AND 3007628272-2011-50011.

    Description of Event or Problem · 1

    THE (B)(4) STUDY INDICATED THAT THE PATIENT WITH ID (B)(4) DEVELOPED A STROKE (INFARCTION) IN THE RIGHT BRAIN AN HOUR AFTER THE PROCEDURE COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE STENT (ENC452212). ADDITIONALLY, THE PATIENT HAD HEMIPLEGIA (LEFT UPPER LIMB) AND SPACIAL NEGLECT WAS NOTED. DRUG THERAPY WAS DONE WITH RADICUT, ARGATROBAN AND HEPARIN. RECOVERY WAS CONFIRMED. (DATE UNKNOWN). THE PHYSICIAN COMMENTED THE THROMBUS MIGHT COME OUT OF THE ANEURYSM. THE MODIFIED RANKIN SCALE PRE-PROCEDURE WAS 3, POST (WITHIN A WEEK) WAS 4, AND POST (AFTER 30 DAYS) WAS 3. PRIOR OR DURING THE PROCEDURE, THROMBUS WAS NOTED AT THE SITE AND PARTIALLY IN THE ANEURYSM. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSED TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THE ENTERPRISE WAS FULLY EXPANDED, APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 1511489

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention