BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3241210 · Received July 22, 2013

    Report

    Report Number
    1058196-2013-00196
    Event Type
    Death
    Date Received
    July 22, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 28, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CAUSE OF DEATH WAS REPORTED AS MALIGNANT CEREBRAL EDEMA, STATUS POST LEFT MCA OCCLUSION AND BILATERAL INTERNAL CAROTID ARTERY DISSECTIONS. PREVIOUSLY REPORTED CODE FOR DEATH HAS BEEN DELETED FROM THE FILE BASED ON THE ADDITIONAL INFORMATION IN THE PROCEDURE REPORT. NO ADDITIONAL INFORMATION WAS OBTAINED THROUGH THE FOLLOW-UP ATTEMPTS. COMPLAINT CONCLUSION: IT WAS REPORTED THAT DURING OFF-LABEL USE OF THE ENTERPRISE TO OPEN A MIDDLE CEREBRAL ARTERY (MCA) THROMBUS THAT THE STENT, WHICH WAS NOT FULLY DEPLOYED IN THE PATIENT, MOVED FORWARD WHEN DEPLOYING. THE STENT WAS PARTIALLY DEPLOYED & THEN RECAPTURED. A CONTROL ANGIOGRAM SHOWED RECANALIZATION OF THE ARTERY; THEREFORE, THE STENT WAS NOT REDEPLOYED; IT WAS NOT IMPLANTED IN THE PATIENT. IT WAS INDICATED THAT THE DEVICE DID NOT MALFUNCTION AND THERE WAS NO DIFFICULTY ENCOUNTERED WITH DEPLOYING OR RETRIEVING OF THE STENT. IT WAS REPORTED THAT THE PATIENT WHO WAS ADMITTED AFTER A MOTORCYCLE ACCIDENT WITH LEFT INTERNAL CAROTID DISSECTION AND OCCLUSION AND COMPLETE BLOCKAGE OF THE LEFT MCA EXPIRED TWO DAYS POST INDEX PROCEDURE DUE TO MALIGNANT CEREBRAL EDEMA STATUS POST BASELINE LEFT MCA OCCLUSION AND INTERNAL ARTERY DISSECTIONS. THE PATIENT WAS ADMITTED AFTER AN AUTO ACCIDENT. AS PER CATH REPORT, THERE WAS COMPETE OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY DUE TO INTERNAL CAROTID ARTERY DISSECTION. THERE WAS NORMAL FILLING OF RIGHT ANTERIOR CIRCULATION WITH A PATENT ANTERIOR COMMUNICATING ARTERY THAT GIVES FLOW TO THE LEFT ANTERIOR CEREBRAL ARTERY AND UPPER PART OF SUPRACLINOID ANTERIOR ARTERY, BUT A COMPLETE BLOCK AT THE PROXIMAL SEGMENT OF LEFT M1 WAS SEEN. THE INTRA-ARTERIAL TPA WAS INJECTED ALONG THE THROMBUS WHICH DID NOT IMPROVE THE FLOW. AN ATTEMPT AT THROMBECTOMY WAS PERFORMED UNDER REVERSAL OF FLOW USING BALLOON OCCLUSION AT THE GUIDING CATHETER TIP AND THE SOLITAIRE 4X15MM CLOT RETRIEVAL DEVICE DEPLOYED FROM PROXIMAL A1 OF THE DISTAL M1 SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. A FIRST PASS YIELDED SOME THROMBUS BUT NO MAJOR CHANGE IN THE APPEARANCE OF THE ARTERIOGRAM EXCEPT FOR OCCLUSION OF THE LEFT A1 AND TINY DISTAL SHOWER IN THE RIGHT A2 TERRITORY. THE DECISION WAS MADE TO TRY TO STENT OPEN THE A1/M1 SEGMENT OF THE LEFT INTRACRANIAL CAROTID ARTERY. THE PATIENT WAS LOADED WITH HALF THE DOSE OF REOPRO BOLUS AND A PROWLER PLUS SELECT MC WAS ADVANCED INTO THE LEFT M2 PORTION OF THE MIDDLE CEREBRAL ARTERY. THE LENGTH OF THE OBSTRUCTION WAS ESTIMATED USING SIMULTANEOUS INJECTION THROUGH A MC AND THE CONCENTRIC GUIDE CATHETER. THEY ATTEMPTED TO DEPLOY 4.5X22MM ENTERPRISE STENT, BUT IT MIGRATED PROXIMALLY DURING THIS MANEUVER. A REPEAT ANGIOGRAM SHOWED PARTIAL OPENING OF THE MIDDLE CEREBRAL ARTERY ON THE LEFT SIDE. FURTHER IMAGING SHOWED PROGRESSIVE OPENING OF THE VESSEL WITH IMPROVEMENT IN FLOW IN LARGE PORTION OF THE LEFT MIDDLE CEREBRAL ARTERY TERRITORY. AT THIS POINT, THE LEFT ANTERIOR CEREBRAL ARTERY WAS COMPLETELY OPENED AND THERE WAS IMPROVEMENT IN THE RIGHT DISTAL A2 FLOW. IT WAS FELT THAT ENOUGH FLOW HAD BEEN REESTABLISHED AND FURTHER MANIPULATION COULD RESULT IN VESSEL INJURY. THEREFORE, THE PROCEDURE WAS TERMINATED. A CONTROL ANGIOGRAM POST THROMBECTOMY SHOWED FILLING OF BOTH ANTERIOR AND MIDDLE CEREBRAL ARTERY DISTRIBUTIONS. FLOW IN THE DISTAL BRANCHES OF BOTH ARTERIES WAS SLOWER, MOST LIKELY OWING TO SOME PARENCHYMAL SWELLING. THERE WAS STILL SOME MILD NARROWING IN THE LEFT M1 SEGMENT DUE TO RESIDUAL THROMBUS. STILL, THERE WERE WAS WHAT APPEARED TO BE GOOD BLUSH IN THE CAPILLARY PHASE IN THE LEFT HEMISPHERE EXCEPT FOR THE PREVIOUSLY KNOWN LEFT OCCIPITAL STROKE AND PROBABLY THE MOST DISTAL BRANCHES OF THE LEFT FRONTAL MIDDLE CEREBRAL ARTERY TERRITORY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED DIRECTLY TO CT SCAN AND ICU. TWO DAYS POST PATIENT DIED. THE CAUSE OF DEATH WAS REPORTED AS MALIGNANT CEREBRAL EDEMA, STATUS POST LEFT MCA OCCLUSION AND BILATERAL INTERNAL CAROTID ARTERY DISSECTIONS. THE STENT WHICH WAS NOT IMPLANTED IS NOT AVAILABLE FOR ANALYSIS. THE DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED AS THE LOT NUMBER PROVIDED IS NOT A VALID LOT NUMBER FOR THIS DEVICE. STENT MOVEMENT/MIGRATION IS A KNOWN POTENTIAL EVENT RELATED TO THE USE OF THE ENTERPRISE VRD AS OUTLINED IN THE INSTRUCTIONS FOR USE. ALTHOUGH NO CONCLUSION CAN BE MADE, CLINICAL/PROCEDURAL FACTORS SUCH AS VESSEL CHARACTERISTICS AND DEPLOYMENT TECHNIQUE ARE FACTORS THAT MAY CONTRIBUTE TO MOVEMENT DURING DEPLOYMENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A REPEAT ANGIOGRAM SHOWED PARTIAL OPENING OF THE MIDDLE CEREBRAL ARTERY ON THE LEFT SIDE. FURTHER IMAGING SHOWED PROGRESSIVE OPENING OF THE VESSEL WITH IMPROVEMENT IN FLOW IN LARGE PORTION OF THE LEFT MIDDLE CEREBRAL ARTERY TERRITORY. AT THIS POINT, THE LEFT ANTERIOR CEREBRAL ARTERY WAS COMPLETELY OPENED AND THERE WAS IMPROVEMENT IN THE RIGHT DISTAL A2 FLOW. IT WAS FELT THAT ENOUGH FLOW HAD BEEN REESTABLISHED AND FURTHER MANIPULATION COULD RESULT IN VESSEL INJURY. THEREFORE THE PROCEDURE WAS TERMINATED. A CONTROL ANGIOGRAM POST THROMBECTOMY SHOWED FILLING OF BOTH ANTERIOR AND MIDDLE CEREBRAL ARTERY DISTRIBUTIONS. FLOW IN THE DISTAL BRANCHES OF BOTH ARTERIES WAS SLOWER, MOST LIKELY OWING TO SOME PARENCHYMAL SWELLING. THERE WAS STILL SOME MILD NARROWING IN THE LEFT M1 SEGMENT DUE TO RESIDUAL THROMBUS. STILL, THERE WERE WAS WHAT APPEARED TO BE GOOD BLUSH IN THE CAPILLARY PHASE IN THE LEFT HEMISPHERE EXCEPT FOR THE PREVIOUSLY KNOWN LEFT OCCIPITAL STROKE AND PROBABLY THE MOST DISTAL BRANCHES OF THE LEFT FRONTAL MIDDLE CEREBRAL ARTERY TERRITORY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED DIRECTLY TO CT SCAN AND ICU. TWO DAYS POST PATIENT DIED. PLEASE NOTE THAT THE INVESTIGATION REGARDING THE CAUSE OF DEATH IS CURRENTLY BEING ATTEMPTED THUS ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENTERPRISE STENT MIGRATED PROXIMALLY DURING THE MANEUVER AND PATIENT DIED TWO DAYS POST PROCEDURE. STENTING WAS ATTEMPTED TO OPEN A THROMBUS, LEFT MCA. STENT WAS PARTIALLY DEPLOYED, THEN RECAPTURED. A CONTROL ANGIOGRAM SHOWED RECANALIZATION OF THE ARTERY, THEREFORE STENT WAS NOT REDEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT. DEVICE DID NOT MALFUNCTION. NO DIFFICULTY WAS ENCOUNTERED WITH DEPLOYING OR RETRIEVING THE STENT. THE PATIENT EXPIRED TWO DAYS LATER. IT WAS REPORTED THAT THE CAUSE OF DEATH IS NOT KNOWN. THE PATIENT WAS ADMITTED AFTER AN AUTO ACCIDENT. AS PER CATH REPORT, THERE WAS COMPETE OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY DUE TO INTERNAL CAROTID ARTERY DISSECTION. THERE WAS NORMAL FILLING OF RIGHT ANTERIOR CIRCULATION WITH A PATENT ANTERIOR COMMUNICATING ARTERY THAT GIVES FLOW TO THE LEFT ANTERIOR CEREBRAL ARTERY AND UPPER PART OF SUPRACLINOID ANTERIOR ARTERY, BUT A COMPLETE BLOCK AT THE PROXIMAL SEGMENT OF LEFT M1 WAS SEEN. THE INTRA-ARTERIAL TPA WERE INJECTED ALONG THE THROMBUS WHICH DID NOT IMPROVE THE FLOW. AN ATTEMPT AT THROMBECTOMY WAS PERFORMED UNDER REVERSAL OF FLOW USING BALLOON OCCLUSION AT THE GUIDING CATHETER TIP AND THE SOLITAIRE 4X15MM CLOT RETRIEVAL DEVICE DEPLOYED FROM PROXIMAL A1 OF THE DISTAL M1 SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. A FIRST PASS YIELDED SOME THROMBUS BUT NO MAJOR CHANGE IN THE APPEARANCE OF THE ARTERIOGRAM EXCEPT FOR OCCLUSION OF THE LEFT A1 AND TINY DISTAL SHOWER IN THE RIGHT A2 TERRITORY. THE DECISION WAS MADE TO TRY TO STENT OPEN THE A1/M1 SEGMENT OF THE LEFT INTRACRANIAL CAROTID ARTERY. THE PATIENT WAS LOADED WITH HALF THE DOSE OF REOPRO BOLUS AND A PROWLER PLUS SELECT MC WAS ADVANCED INTO THE LEFT M2 PORTION OF THE MIDDLE CEREBRAL ARTERY. THE LENGTH OF THE OBSTRUCTION WAS ESTIMATED USING SIMULTANEOUS INJECTION THROUGH A MC AND THE CONCENTRIC GUIDE CATHETER. THEY ATTEMPTED TO DEPLOY 4.5X22MM ENTERPRISE STENT, BUT IT MIGRATED PROXIMALLY DURING THIS MANEUVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341292 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death