BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6031321 · Received October 14, 2016

    Report

    Report Number
    1226348-2016-00150
    Event Type
    Death
    Date Received
    October 14, 2016
    Date of Event
    September 14, 2016
    Report Date
    September 19, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    UDI-DI
    10886704075394
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTACT FROM THE FACILITY REPORTED THAT A FEMALE STUDY SUBJECT PRESENTED WITH A SUBARACHNOID HEMORRHAGE. HER HUNT AND HESS GRADE UPON ADMISSION TO THE HOSPITAL WAS 3. FOLLOWING PLACEMENT OF A VENTRICULOSTOMY CATHETER, THE PATIENT WAS BROUGHT TO THE ANGIOSUITE, AND A DIAGNOSTIC CEREBRAL WAS PERFORMED. ANGIOGRAM REVEALED A FUSIFORM DISSECTING ANEURYSM OF THE DISTAL BASILAR ARTERY. THE DECISION WAS TO TREAT THE ANEURYSM IN A STAGED FASHION, USING THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (CODMAN). THE INTENT WAS TO PLACE TWO STENTS INITIALLY WITHIN DISSECTING FUSIFORM DISTAL BASILAR ARTERY ANEURYSM FOR FLOW DIVERSION PURPOSES. THE INTENT WAS THEN TO PERFORM FOLLOW UP ANGIOGRAM IN 2 DAYS TO REASSESS ANEURYSM AND POSSIBLY TREAT WITH ADDITIONAL STENT PLACEMENT OR COILING DEPENDING ON ANEURYSM APPEARANCE AT FOLLOW UP. THE PATIENT'S HUSBAND WAS CONSENTED FOR THE PROCEDURE. TWO ENTERPRISE STENTS (ENF403912/10694541) AND (ENF402312/10632707) WERE PLACED IN THE BASILAR ARTERY, BRIDGING THE FUSIFORM ANEURYSM. THE DISTAL VESSEL DIAMETER WAS 2.25 MM AND THE PROXIMAL VESSEL DIAMETER WAS 2.9 MM. THE STENTS WERE PLACED WITHOUT COMPLICATION. ANGIOGRAM FOLLOWING STENT PLACEMENT REVEALED NO NORMAL VESSEL OCCLUSION, AND SLIGHT CHANGE OF FLOW PATTERN WITHIN THE ANEURYSM. THERE WAS NO EVIDENCE OF VESSEL DAMAGE AFTER STENT PLACEMENT. THE DISTAL AND PROXIMAL ENDS OF THE SECOND STENT DID NOT FULLY EXPAND BUT THERE WAS NO LIMITATION OF BLOOD FLOW AS A RESULT. THERE APPEARED TO BE GOOD WALL APPOSITION WITH THE STENT AND THE VESSEL. THERE WAS NO EVIDENCE OF CLOT OR PLATELET AGGREGATION. AT THE COMPLETION OF THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE FIXED DILATED PUPILS, AND DIMINISHED BRAIN STEM REFLEXES. CT OF THE HEAD REVEALED NO NEW HEMORRHAGE. THE HUNT AND HESS GRADE AFTER THE PROCEDURE WAS 5. REPEAT ANGIOGRAM DEMONSTRATED NO EVIDENCE OF MAJOR BASILAR BRANCH ARTERY OCCLUSION, AND THE BASILAR ARTERY WAS PATENT. THE PATIENT DIDN'T RECOVER BRAIN STEM FUNCTION, AND SHE WAS DECLARED BRAIN DEAD A DAY LATER MOST PROBABLY FROM A BRAIN STEM INFARCT. THE DEVICES ARE IMPLANTED AND NOT AVAILABLE FOR RETURN. PER LR FILE # (B)(4). LR PACKAGING L/N 10632707. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE ABOVE MENTIONED LOT. 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 LAKE REGION MEDICAL¿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. BRAIN STEM INFARCTION, WHILE NOT SPECIFICALLY LISTED WITHIN THE IFU, IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD DEVICE WHEN USED IN THE BASILAR ARTERY LOCATIONS. THE ENETRPRISE VRD LISTS DEATH, INJURY TO NORMAL TISSUES, ISCHEMIA AND STROKE AS POTENTIAL ADVERSE EVENTS. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT THE TARGET LESION ANATOMY AND ANEURYSM CHARACTERISTICS AS WELL AS PROGRESSION OF THE PRESENTING NEUROLOGIC DEFICITS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS REPORT IS RELATED TO MFR REPORT # 1226348-2016-00151.

    Description of Event or Problem · 1

    THE CONTACT FROM THE FACILITY REPORTED THAT A FEMALE STUDY SUBJECT PRESENTED WITH A SUBARACHNOID HEMORRHAGE. HER HUNT AND HESS GRADE UPON ADMISSION TO THE HOSPITAL WAS 3. FOLLOWING PLACEMENT OF A VENTRICULOSTOMY CATHETER, THE PATIENT WAS BROUGHT TO THE ANGIOSUITE, AND A DIAGNOSTIC CEREBRAL WAS PERFORMED. ANGIOGRAM REVEALED A FUSIFORM DISSECTING ANEURYSM OF THE DISTAL BASILAR ARTERY. THE DECISION WAS TO TREAT THE ANEURYSM IN A STAGED FASHION, USING THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (CODMAN). THE INTENT WAS TO PLACE TWO STENTS INITIALLY WITHIN DISSECTING FUSIFORM DISTAL BASILAR ARTERY ANEURYSM FOR FLOW DIVERSION PURPOSES. THE INTENT WAS THEN TO PERFORM FOLLOW UP ANGIOGRAM IN 2 DAYS TO REASSESS ANEURYSM AND POSSIBLY TREAT WITH ADDITIONAL STENT PLACEMENT OR COILING DEPENDING ON ANEURYSM APPEARANCE AT FOLLOW UP. THE PATIENT'S HUSBAND WAS CONSENTED FOR THE PROCEDURE. TWO ENTERPRISE STENTS (ENF403912/10694541) AND (ENF402312/10632707) WERE PLACED IN THE BASILAR ARTERY, BRIDGING THE FUSIFORM ANEURYSM. THE DISTAL VESSEL DIAMETER WAS 2.25 MM AND THE PROXIMAL VESSEL DIAMETER WAS 2.9 MM. THE STENTS WERE PLACED WITHOUT COMPLICATION. ANGIOGRAM FOLLOWING STENT PLACEMENT REVEALED NO NORMAL VESSEL OCCLUSION, AND SLIGHT CHANGE OF FLOW PATTERN WITHIN THE ANEURYSM. THERE WAS NO EVIDENCE OF VESSEL DAMAGE AFTER STENT PLACEMENT. THE DISTAL AND PROXIMAL ENDS OF THE SECOND STENT DID NOT FULLY EXPAND BUT THERE WAS NO LIMITATION OF BLOOD FLOW AS A RESULT. THERE APPEARED TO BE GOOD WALL APPOSITION WITH THE STENT AND THE VESSEL. THERE WAS NO EVIDENCE OF CLOT OR PLATELET AGGREGATION. AT THE COMPLETION OF THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE FIXED DILATED PUPILS, AND DIMINISHED BRAIN STEM REFLEXES. CT OF THE HEAD REVEALED NO NEW HEMORRHAGE. THE HUNT AND HESS GRADE AFTER THE PROCEDURE WAS 5. REPEAT ANGIOGRAM DEMONSTRATED NO EVIDENCE OF MAJOR BASILAR BRANCH ARTERY OCCLUSION, AND THE BASILAR ARTERY WAS PATENT. THE PATIENT DIDN'T RECOVER BRAIN STEM FUNCTION, AND SHE WAS DECLARED BRAIN DEAD A DAY LATER MOST PROBABLY FROM A BRAIN STEM INFARCT. THE DEVICES ARE IMPLANTED AND NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681795 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA 10694541 10886704075394

    Patients

    Seq Age Sex Outcome Treatment
    1 Death