BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2091702 · Received May 17, 2011

    Report

    Report Number
    1058196-2011-00237
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    March 4, 2011
    Report Date
    April 25, 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

    CONCOMITANT MEDICAL PRODUCTS: PROWLER SELECT PLUS MICROCATHETER, SL10 MICROCATHETER, SYNCHRO GUIDEWIRE, FAST TRACKER (BOSTON SCIENTIFIC), 2 ORBIT COILS (637MF0202 (LOT 15145627 AND 637MF2535 LOT 15175298), CASHMERE COILS (QTY 7), HYDRO COIL (QTY 20 ), AND DELTA PLUSH COILS (QTY 15). THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00236 AND 1058196-2011-00237. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED FROM CLINICAL STUDY "(B)(4) PMS ENTERPRISE" PATIENT ID# (B)(6) INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION (ORBIT) ASSISTED WITH AN ENTERPRISE VRD ((B)(4)) OF AN ANEURYSM IN THE RIGHT CAVERNOUS SINUS, AND FOUR DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED MULTIPLE VISIONS (ABDUCENS NERVE PARALYSIS). THE PHYSICIAN CONSIDERED THE EVENT AS TEMPORARY PRESSURE SYMPTOM CAUSED BY THROMBOSED LARGE ANEURYSM, ADDITIONALLY, AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, THE STENT WAS PATENT AND THE THROMBOSIS WAS CONTAINED WITHIN THE ANEURYSM. METHYCOBAL WAS ADMINISTERED, AND RECOVERY WAS CONFIRMED. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THE ENTERPRISE WAS FULLY EXPANDED, APPOSE 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. THE MODIFIED RANKIN SCALE PRE-PROCEDURE 0, AFTER (WITHIN A WEEK) WAS 1, AND AT (30 DAYS AND AFTER) WAS 1. THE ACT PRE-PROCEDURE WAS 111 SECONDS AND POST-PROCEDURE WAS 216 SECONDS. THE ANEURYSM WAS UNRUPTURED. THE SACCULAR ANEURYSM MEASURE AT THE NECK WAS 6.9MM AND NECK TO SAC RATIO WAS 6.9MM/12.3MM. THE PARENT VESSEL DIAMETER PROXIMALLY WAS 4.0MM AND DISTALLY WAS 3.6MM. PRODUCTS UTILIZED DURING THE CASE CONSISTED OF PROWLER SELECT PLUS MICROCATHETER, SL10 MICROCATHETER, SYNCHRO GUIDEWIRE, FAST TRACKER (BOSTON SCIENTIFIC), 2 ORBIT COILS ((B)(4) (LOT 15145627 AND (B)(4) LOT 15175298), CASHMERE COILS (QTY 7), HYDRO COIL (QTY 20 ), AND DELTA PLUSH COILS (QTY 15 ). MEDICATIONS CONSISTED OF BAYASPIRIN 100MG/DAY (2/21/2011-) AND PLAVIX 77MG/DAY (2/21/2011-). A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION IS 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 15175298 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE 26 UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. THE NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. WHILE NOT SPECIFICALLY LISTED IN THE IFU, ABDUCENS NERVE PALSY IS A NEUROLOGIC DEFICIT AND MAY BE RELATED TO INJURY TO NORMAL TISSUE POST STENT AND COIL IMPLANTATION. NEUROLOGIC DEFICITS AND DAMAGE TO NORMAL TISSUE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE IMPLANTATION OF INTRACRANIAL STENTS AND ANEURYSM COILS AND ARE LISTED IN THE IFU OF BOTH THE ENTERPRISE STENT AND DCS ORBIT COILS AS SUCH. SIXTH NERVE PALSY, OR ABDUCENS NERVE PALSY, IS A DISORDER ASSOCIATED WITH DYSFUNCTION OF CRANIAL NERVE VI (THE ABDUCENS NERVE), WHICH IS RESPONSIBLE FOR CONTRACTING THE LATERAL RECTUS MUSCLE TO ABDUCT (I.E., TURN OUT) THE EYE. THE INABILITY OF AN EYE TO TURN OUTWARD RESULTS IN A CONVERGENT STRABISMUS OR ESOTROPIA OF WHICH THE PRIMARY SYMPTOM IS DOUBLE VISION OR DIPLOPIA IN WHICH THE TWO IMAGES APPEAR SIDE-BY-SIDE. THE CONDITION IS COMMONLY UNILATERAL BUT CAN ALSO OCCUR BILATERALLY. BECAUSE, THE NERVE EMERGES NEAR THE BOTTOM OF THE BRAIN, IT IS OFTEN THE FIRST NERVE COMPRESSED WHEN THERE IS ANY RISE IN INTRACRANIAL PRESSURE. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE LOCATION OF THIS PATIENT'S TARGET ANEURYSM AND THE IMPLANTATION OF THE DEVICES MAY HAVE ACTED IN CONCERT TO INCREASE THE INTRACRANIAL PRESSURE AND/OR CREATED SWELLING IN THE TISSUE LOCATED ADJACENT TO THE ANEURYSM CONTRIBUTING TO THE REPORTED SYMPTOMS. CORRECTED DATA: THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00244, 1058196-2011-00236 AND 1058196-2011-00237.

    Description of Event or Problem · 1

    THE REPORT FROM CLINICAL STUDY (B)(4) PATIENT ID (B)(4) INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION (ORBIT) ASSISTED WITH AN ENTERPRISE VRD (ENC453712) OF AN ANEURYSM IN THE RIGHT CAVERNOUS SINUS, AND FOUR DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED MULTIPLE VISIONS (ABDUCENS NERVE PARALYSIS). THE PHYSICIAN CONSIDERED THE EVENT AS TEMPORARY PRESSURE SYMPTOM CAUSED BY THROMBOSED LARGE ANEURYSM, ADDITIONALLY, AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, THE STENT WAS PATENT AND THE THROMBOSIS WAS CONTAINED WITHIN THE ANEURYSM. METHYCOBAL WAS ADMINISTERED, AND RECOVERY WAS CONFIRMED. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE 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. THE ANEURYSM WAS UNRUPTURED. THE SACCULAR ANEURYSM MEASURE AT THE NECK WAS 6.9MM AND NECK TO SAC RATIO WAS 6.9MM/12.3MM. THE PARENT VESSEL DIAMETER PROXIMALLY WAS 4.0MM AND DISTALLY WAS 3.6MM. MEDICATIONS CONSISTED OF BAYASPIRIN 100MG/DAY ((B)(6) 2011) AND PLAVIX 77MG/DAY ((B)(6) 2011). A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15175298

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention