BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5769010 · Received July 5, 2016

    Report

    Report Number
    1226348-2016-00115
    Event Type
    Injury
    Date Received
    July 5, 2016
    Date of Event
    May 29, 2016
    Report Date
    June 13, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF ONE FINAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT. LR FILE # (B)(4). LR PACKAGING (B)(4). 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. DEPLOYMENT DIFFICULTY IS A KNOWN POTENTIAL PRODUCT MALFUNCTION AND THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE DEVICE. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. THIS WAS AN OFF LABEL USE OF THE ENTERPRISE. THE IFU DOES NOT ADDRESS POTENTIAL HARMS TO THE PATIENT ASSOCIATED WITH OFF LABEL USE. THE DECISION TO USE A DEVICE IN AN OFF LABEL MANNER RESTS WITH THE CLINICIAN PERFORMING THE PROCEDURE. IN MANY CASES, WHERE OFF LABEL APPLICATIONS ARE USED, IT IS BECAUSE THERE ARE NO OTHER ALTERNATIVES AND THE CLINICIAN IS GIVING THE PATIENT THE BEST POSSIBLE OPTION IN A CRITICAL SITUATION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT TARGET LESION CHARACTERISTICS, VESSEL ANATOMY, MEDICATION REGIMEN AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO NEED FOR FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF ONE INITIAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT. (B)(4). CONCOMITANT DEVICES: 9-FRENCH RIGHT FEMORAL SHEATH (TYPE/LOT UNKNOWN); 5-FRENCH CATHETER (TYPE/LOT UNKNOWN); 9-FRENCH BALLOON GUIDE CATHETER (TYPE/LOT UNKNOWN); MICROCATHETER (TYPE/LOT UNKNOWN); SOLITAIRE DEVICE (LOT UNKNOWN); 6- FRENCH GUIDE CATHETER (TYPE/LOT UNKNOWN); TREVO DEVICE 3MM X 9MM BALLOON (TYPE/LOT UNKNOWN). (B)(4). THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS HOWEVER A DEVICE HISTORY RECORD REVIEW IS CURRENTLY BEING CONDUCTED AND THE RESULTS ARE NOT YET AVAILABLE. NO CONCLUSION IS MADE AT THIS TIME

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING OFF-LABEL USE OF AN ENTERPRISE STENT (ENF401612/LOT 10591172), SLOWING OF THE ANTERGRADE FILLING AND THROMBOSIS OF THE STENT WAS OBSERVED POST-STENT DEPLOYMENT. THE PATIENT HAD PRESENTED WITH A RIGHT HEMISPHERE STROKE AND RECEIVED IV-TISSUE PLASMINOGEN ACTIVATOR. DURING THE STROKE INTERVENTION IT WAS FOUND THAT SHE HAS A TERMINUS OCCLUSION OF THE RIGHT INTERNAL CAROTID ARTERY INTRACRANIALLY. THE CLOT WAS ACCESSED AND AN EMBOLECTOMY DEVICE (COMPETITOR¿S) WAS POSITIONED ACROSS THE CLOT AND DEPLOYED. EMBOLECTOMY WAS PERFORMED BY INFLATING THE OCCLUDING BALLOON ON THE GUIDE CATHETER, ASPIRATING ON THE DISTAL ACCESS CATHETER AND BY REMOVING THE EMBOLECTOMY DEVICE. THERE STILL REMAINED COMPLETE OCCLUSION OF THE VESSEL. A SECOND PASS WITH THE SAME DEVICE WAS PERFORMED WITH THE SAME RESULTS. NEXT, A 4MM SNARE DEVICE (UNKNOWN MANF) WAS USED AND ENGAGED THE PROXIMAL END OF THE CLOT. A SMALL PIECE OF THE CLOT WAS REMOVED. ANGIOGRAM THROUGH THE DISTAL ACCESS CATHETER DEMONSTRATED A PARTIAL RECANALIZATION OF THE TERMINUS OF THE INTERNAL CAROTID AND M1 SEGMENT. THERE WAS NO ANTEGRADE FILLING OF THE ANTERIOR CEREBRAL ARTERY, HOWEVER THERE WAS A SLOW FLOW THROUGH AN EXTREMELY STENOTIC PROXIMAL M1 SEGMENT. SUBSEQUENTLY, A PASS WITH A TREVO DEVICE WAS PERFORMED THIS ALSO WAS UNSUCCESSFUL. THE GUIDE CATHETER WAS EXCHANGED FOR A 6-FRENCH GUIDE CATHETER; THE POSTERIOR DIVISION OF THE RIGHT MIDDLE CEREBRAL ARTERY WAS SELECTED DISTALLY. A SUPPORT WIRE WAS PLACED AND THE MICROCATHETER WAS EXCHANGED FOR A 3MM X 9MM BALLOON. THE CLOT WAS ANGIOPLASTIED AND THERE WAS ANTEGRADE FLOW. AN ANGIOGRAM WAS PERFORMED WHICH SHOWED THE VESSEL HAD REOCCLUDED. THE BALLOON WAS EXCHANGED FOR A MICROCATHETER AND THEN AN ENTERPRISE STENT (4MM X 16 MM) WAS DEPLOYED ACROSS THE CLOT. IT WAS REPORTED THAT THE STENT DID NOT FULLY EXPAND PROXIMALLY. THE DIAMETER OF THE PARENT VESSEL WAS NOT MEASURED HOWEVER WAS ABOUT 2.5 MM-3.5 MM. ANGIOGRAMS PERFORMED DEMONSTRATED A SLOW ANTEGRADE FLOW THROUGH AN EXTREMELY STENOTIC VESSEL AT THE SIDE OF THE CLOT, SUGGESTING THROMBOSIS OF THE STENT. THE FINAL ANGIOGRAPHIC VIEW DEMONSTRATED GOOD ANTEGRADE FILLING OF THE ANTERIOR CEREBRAL ARTERY AND THE ANTERIOR CHOROIDAL AND POSTERIOR COMMUNICATING ARTERY, HOWEVER THERE IS SLOW ANTEGRADE FLOW THROUGH THE MIDDLE CEREBRAL ARTERY ORIGIN. THERE WERE NO INTRA-PROCEDURAL COMPLICATIONS OR ANY VESSEL DAMAGE /DISSECTION RELATED TO THE ENTERPRISE DEVICE. UNABLE TO REVIEW THE SYSTEMS DUE TO CLINICAL CONDITION OF THE PATIENT AND ALTERED MENTAL STATUS AT THE 24-HOUR FOLLOW-UP. PATIENT HAD POOR NEUROLOGICAL RECOVERY SINCE THE PROCEDURE. HER NIH STROKE SCALE AT BASELINE WAS 17 AND REMAINED AT 15 AT THE 24 HOUR MARK. THE PATIENT CONTINUES TO RECOVER AT HOME WITH HOSPICE. THE STENT REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422479 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC 10591172

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention