BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1911638 · Received December 1, 2010

    Report

    Report Number
    1058196-2010-00355
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 20, 2009
    Report Date
    November 30, 2009
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 9FRENCH SHEATH, BALLOON CATHETER, PROTECTIN DEVICE, MICROCATHETERS, AND STENTS. THE DAY OF THE EVENT, THE PATIENT WAS AT WORK WHEN HIS COLLEAGUES FOUND HIM STARING INTO SPACE WITHOUT RESPONDING TO VERBAL COMMANDS, RIGHT LEG WAS WEAK, AND SPEECH DIFFICULTIES AND WEAKNESS. UPON ADMISSION AT THE FIRST HOSPITAL, THE PATIENT DEMONSTRATED PREDOMINANTLY EXPRESSIVE APHASIC AND RIGHT HEMIPARESIS. A CT HEAD OBTAINED AT THE HOSPITAL DID NOT REVEAL ANY ACUTE INTRACRANIAL PATHOLOGY BUT DID NOT SHOW AN AREA OF HYPO-DENSITY IN THE LEFT PARIETAL REGION. THERE WERE SMALL PUNCTATE FOCI OF HYPER-DENSITY AS WELL NOTED IN THE SCAN. IV TPA WAS NOT ADMINISTERED DUE TO THE UNCERTAIN CT FINDINGS. THE PATIENT WAS TRANSFERRED TO A SECOND HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. ON ARRIVAL TO THE SECOND HOSPITAL, THE PATIENT REMAINED APHASIC PREDOMINANTLY IN THE EXPRESSIVE REALMS, WEAKNESS IN THE RIGHT FACE AND ARM GREATER THAN LEG. A CT PERFUSION AND CT ANGIOGRAM OF THE HEAD AND NECK REVEALED A LARGE ZONE OF ISCHEMIC PENUMBRA INVOLVING THE LEFT FRONTAL AND PARIETAL LOBES INVOLVING BOTH THE ACA AND MCA DISTRIBUTION. THE PATIENT WAS TAKING TO THE ANGIOGRAM SUITE, AND THE ANGIOGRAM SHOWED AN ACUTE OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY AT ITS ORIGIN. URGENT REVASCULARIZATION WAS PERFORMED. A DISTAL PROTECTION DEVICE WAS PLACED THROUGH THE STENOSIS AND UP TO THE C1 LEVEL OF THE CERVICAL CAROTID. A STERLING BALLOON WAS DEPLOYED ACROSS THE STENOSIS AND INFLATED. FOLLOWED, BY PLACEMENT OF THE PRECISE STENT. FOLLOW-UP ANGIOGRAM OF THE LEFT COMMON CAROTID ARTERY DEMONSTRATED PERSISTENT OCCLUSION OF THE INTERNAL CAROTID ARTERY. THIS ANGIOGRAM SHOWED CLOT IN THE M1 SEGMENT. A MERCI DEVICE WAS USED TO ATTEMPT CLOT RETRIEVAL IN THE M1 SEGMENT. THIS RESULTED IN RETRIEVAL OF A SMALL AMOUNT OF CLOT. HOWEVER, MICROCATHETER INJECTIONS DEMONSTRATED THAT THE CLOT EXTENDED DOWN INTO THE CAVERNOUS CAROTID. DURING MICROCATHETER MANIPULATIONS, A TOTAL OF 15MG OF R-TPA WAS INJECTED IN THE CLOT FROM THE CAVERNOUS CAROTID ARTERY TO THE MIDDLE CEREBRAL ARTERY. THIS WAS NOT SUCCESSFUL. FINALLY IT WAS DECIDED TO TREAT THE OCCLUSION WITH TWO ENTERPRISE STENTS (4.5X28 AND 4.5X22). FURTHER DETAILS, REVIEW OF SYSTEMS ARE NOT POSSIBLE GIVEN THE PATIENT'S APHASIA. FINAL FINDINGS, LEFT CEREBRAL INFARCTION STATUS POST THROMBOLYSIS AND STENTING, RIGHT HEMIPARESIS AND APHASIA, RIGHT VISUAL IMPAIRMENT, IMPAIRMENT MOBILITY AND SELF CARES, TYPE 2 DIABETES MELLITUS, URINARY TRACT INFECTION, DYSPHAGIA, A-FRILE, VITAL SIGNS STABLE, AND MEDICALLY STABLE. THE PATIENT WAS DISCHARGED HOME WITH CONTINUE REHABILITATION AND 24 HOUR ASSISTANCE. THIS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORTS 1058196-2010-00354, 1058196-2010-00355, AND 9616099-2010-00901. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING AN EMERGENT CASE, A PRECISE STENT (PC0830RXC) WAS IMPLANTED TO TREAT AN ACUTE OCCLUSION OF THE ORIGIN OF THE LEFT INTERNAL CAROTID ARTERY, BUT AFTER PLACEMENT THERE WAS THROMBOEMBOLI OF THE LEFT MIDDLE CEREBRAL ARTERY AND THE SUPRACLINOID INTERNAL CAROTID ARTERY. IT WAS REPORTED THAT THE THROMBOEMBOLI WAS TREATED WITH OFF-LABEL USE OF TWO ENTERPRISE STENTS. THE ENTERPRISE VRD IS INDICATED FOR USE WITH EMBOLIC COILS FOR THE TREATMENT OF WIDE-NECK, INTRACRANIAL, SACCULAR OR FUSIFORM ANEURYSMS. A 4.5X28 ENTERPRISE WAS PLACED EXTENDING FROM THE PROXIMAL M1 SEGMENT DOWN TO THE SUPRACLINOID INTERNAL CAROTID ARTERY, FOLLOW BY A SECOND ENTERPRISE STENT, A 4.5X22 PLACED THROUGH THE PREVIOUS STENT INTO THE M1-M2 SEGMENT. FOLLOW-UP ANGIOGRAMS OF THE LEFT COMMON CAROTID SHOWED RESTORATION OF FLOW INTO THE MIDDLE CEREBRAL ARTERY THROUGH THE SUPRACLINOID INTERNAL CAROTID ARTERY. HOWEVER, THERE WAS SOME PERSISTENT SHAGGY CLOT ALONG THE SUPRACLINOID INTERNAL CAROTID ARTERY, MIDDLE CEREBRAL ARTERY M 1 SEGMENT, AND ANTERIOR CEREBRAL ARTERY A 1 SEGMENT. PRIOR TO THE INDEX PROCEDURE THE PATIENT WAS ADMITTED WITH CHANGE IN MENTAL STATUS, RIGHT SIDED WEAKNESS, AND APHASIA. CT ANGIOGRAM REVEALED A LARGE ZONE OF ISCHEMIC PENUMBRA INVOLVING THE LEFT FRONTAL AND PARIETAL LOBES INVOLVING BOTH THE ACA AND MCA DISTRIBUTION. THE PATIENT WAS TAKING TO THE ANGIOGRAM SUITE, AND THE ANGIOGRAM SHOWED AN ACUTE OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY AT ITS ORIGIN. URGENT REVASCULARIZATION WAS PERFORMED. A DISTAL PROTECTION DEVICE WAS PLACED THROUGH THE STENOSIS AND UP TO THE C1 LEVEL OF THE CERVICAL CAROTID. A STERLING BALLOON WAS DEPLOYED ACROSS THE STENOSIS AND INFLATED, FOLLOWED, BY PLACEMENT OF THE PRECISE STENT. FOLLOW-UP ANGIOGRAM OF THE LEFT COMMON CAROTID ARTERY DEMONSTRATED PERSISTENT OCCLUSION OF THE INTERNAL CAROTID ARTERY. THIS ANGIOGRAM SHOWED CLOT IN THE M1 SEGMENT. A MERCI DEVICE WAS USED TO ATTEMPT CLOT RETRIEVAL IN THE M1 SEGMENT. THIS RESULTED IN RETRIEVAL OF A SMALL AMOUNT OF CLOT. HOWEVER, MICROCATHETER INJECTIONS DEMONSTRATED THAT THE CLOT EXTENDED DOWN INTO THE CAVERNOUS CAROTID. DURING MICROCATHETER MANIPULATIONS, A TOTAL OF 15MG OF R-TPA WAS INJECTED IN THE CLOT FROM THE CAVERNOUS CAROTID ARTERY TO THE MIDDLE CEREBRAL ARTERY. THIS WAS NOT SUCCESSFUL. FINALLY IT WAS DECIDED TO TREAT THE OCCLUSION WITH TWO ENTERPRISE STENTS (4.5X28 AND 4.5X22). FURTHER DETAILS, REVIEW OF SYSTEMS ARE NOT POSSIBLE GIVEN THE PATIENT'S APHASIA. FINAL FINDINGS, LEFT CEREBRAL INFARCTION STATUS POST THROMBOLYSIS AND STENTING, RIGHT HEMIPARESIS AND APHASIA, RIGHT VISUAL IMPAIRMENT, IMPAIRMENT MOBILITY AND SELF CARE. VITAL SIGNS WERE STABLE. THE PATIENT WAS MEDICALLY STABLE AND WAS DISCHARGED HOME WITH CONTINUE REHABILITATION AND 24 HOUR ASSISTANCE. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01406172 WHICH CORRESPONDS TO CORDIS LOT 13470931. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), 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. AS REPORTED, THE ENTERPRISE VRDS WERE USED OFF-LABEL; USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. WITH REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE REPORTED PERSISTENCE OF CLOT AFTER IMPLANTATION OF THE ENTERPRISE VRD IS RELATED TO ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES, BUT APPEARS TO BE RELATED TO PROCEDURAL FACTORS, VESSEL CHARACTERISTICS AND THE CHARACTERISTIC OF THE THROMBUS THAT WAS PRESENT AND BEING TREATED WITH THE ENTERPRISE VRDS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2010-00354, 1058196-2010-00355, AND 9616099-2010-00901.

    Description of Event or Problem · 1

    DURING AN EMERGENT CASE, A PRECISE STENT (PC0830RXC) WAS IMPLANTED TO TREAT AN OCCLUSION OF THE ORIGIN OF THE LEFT INTERNAL CAROTID ARTERY WITH A STENOTIC LESION, BUT AFTER PLACEMENT THERE WAS THROMBOEMBOLI OF THE LEFT MIDDLE CEREBRAL ARTERY AND THE SUPRACLINOID INTERNAL CAROTID ARTERY. THE THROMBOEMBOLI WAS TREATED WITH TWO ENTERPRISE STENT A 4.5X28 PLACED EXTENDING FROM THE PROXIMAL M1 SEGMENT DOWN TO THE SUPRACLINOID INTERNAL CAROTID ARTERY, FOLLOW BY A SECOND ENTERPRISE STENT 4.5X22 PLACED THROUGH THE PREVIOUS STENT INTO THE M1-M2 SEGMENT. FOLLOW-UP ANGIOGRAMS DEMON OF THE LEFT COMMON CAROTID SHOWED RESTORATION OF FLOW INTO THE MIDDLE CEREBRAL ARTERY THROUGH THE SUPRACLINOID INTERNAL CAROTID ARTERY. HOWEVER, THERE WAS SOME PERSISTENT SHAGGY CLOT ALONG THE SUPRACLINOID INTERNAL CAROTID ARTERY, MIDDLE CEREBRAL ARTERY M 1 SEGMENT, AND ANTERIOR CEREBRAL ARTERY A 1 SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. 13470931

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention