BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5604014 · Received April 25, 2016

    Report

    Report Number
    1226348-2016-00068
    Event Type
    Injury
    Date Received
    April 25, 2016
    Date of Event
    September 11, 2015
    Report Date
    April 8, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING RESULTS: (B)(6). (B)(4). CONCLUSION: THE DEVICE WAS IMPLANTED, AND NOT AVAILABLE FOR ANALYSIS. LAKE REGION MEDICAL REVIEWED 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. STROKE AND NEUROLOGICAL DEFICIT ARE KNOWN POTENTIAL EVENTS ASSOCIATED WITH THE ENTERPRISE STENT AND WITH CEREBRAL STENTING/COILING PROCEDURES. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT; HOWEVER, PATIENT OR PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, APPROXIMATELY THREE DAYS AFTER PLACEMENT OF A 4.5 X 14MM ENTERPRISE STENT (ENF451412/10490586) AND ORBIT GALAXY COILS FOR TREATMENT OF AN 5.4 X 3.7 X 3.6 MM, NECK 3.5 MM UNRUPTURED RIGHT SUPERIOR HYPOPHYSEAL ANEURYSM, THE PATIENT EXPERIENCED HEADACHE AND LEFT UPPER EXTREMITY NUMBNESS. PRIOR TO THE PROCEDURE, THE PATIENT PRESENTED WITH LEFT SIDE PTOSIS, HEADACHES, NUMBNESS LEFT JAW AND LEFT SHOULDER AND NECK PAIN. THE DAY FOLLOWING THE PROCEDURE, IT WAS NOTED THAT THE PATIENT WAS NOT AT THERAPEUTIC LEVEL OF PLAVIX, AND AFTER MEDICATION ADJUSTMENT 4 DAYS LATER, SHE WAS AT THERAPEUTIC LEVEL. THREE DAYS AFTER THE PROCEDURE, CTA SHOWED A SMALL AREA OF SUBARACHNOID HEMORRHAGE AND MRI SHOWED SCATTERED EMBOLIC INFARCTS IN THE FRONTAL AND PARIETAL LOBES. THE ANEURYSM DID NOT RUPTURE, AND THE ANEURYSM WAS COMPLETELY OCCLUDED. IT WAS REPORTED THAT THERE WERE NO ISSUES WITH THE COILS, AND THE STENT WAS PATENT WITHOUT THROMBUS. THE PATIENT WAS TREATED WITH BLOOD PRESSURE CONTROL AND MONITORING, AND PAIN CONTROL. SHE RECOVERED, WITH SYMPTOMS RESOLVED, AND WAS STABLE FOR DISCHARGE APPROXIMATELY FOUR DAYS LATER. IT WAS REPORTED THAT AFTER STENT DEPLOYMENT, THE STENT WAS FULLY EXPANDED AND APPOSED TO THE VESSEL WALL, AND NO COILS PROTRUDED INTO THE PARENT VESSEL. ANGIOGRAPHY PERFORMED APPROXIMATELY 7 MONTHS AFTER STENT IMPLANTATION REVEALED REDEMONSTRATION OF RIGHT INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT ANEURYSM STATUS POST COILING WITHOUT EVIDENCE OF SIGNIFICANT COIL COMPACTION. THE DEVICE WAS IMPLANTED, AND NOT AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259126 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC 10490586

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| S ORBIT GALAXY COILS