BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1620296 · Received February 26, 2010

    Report

    Report Number
    1058196-2010-00053
    Event Type
    Injury
    Date Received
    February 26, 2010
    Date of Event
    January 27, 2010
    Report Date
    February 1, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDEH60001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OZRETIC, D., PAVALISA, J., & RADOS, M. (2010). SOLE STENTING OF LARGE AND GIANT INTRACRANIAL ANEURYSMS WITH SELF-EXPANDING INTRACRANIAL STENTS-LIMITS AND COMPLICATION. ACTA NEUROCHIR, DOI 10.1007/S00701-0090592-Y. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PT, WHICH IS ASSOCIATED WITH MFG REPORT #1058196-2010-00051 & 1058196-2010-00052. ADD'L INFO WIL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AS PUBLISHED IN THE JANUARY 27 2010 ONLINE EDITION OF ACTA NEUROCHIR DOI 10.1007/S00701-009-0592-Y IN "SOLE STENTING OF LARGE AND GIANT INTRACRANIAL ANEURYSMS WITH SELF-EXPANDING INTRACRANIAL STENTS- LIMITS AND COMPLICATIONS" A LARGE UNRUPTURED LEFT INTERNAL CAROTID ARTERY ANEURYSM WAS TREATED WITHOUT COIL EMBOLIZATION WITH PLACEMENT OF 3 ENTERPRISE STENTS AND A NONCORDIS STENT IN A STENT-IN-STENT CONFIGURATION WITH THE AIM OF ACHIEVING HIGHER SURFACE AREA COVERAGE OF THE ANEURYSM NECK. AT 24 HOURS POST PLACEMENT, THE PATIENT DEVELOPED SUDDEN RIGHT HEMIPARESIS AND LOSS OF CONSCIOUSNESS. CT SCAN REVEALED ACUTE SUBARACHNOID HEMORRHAGE AND AN ACUTE ISCHEMIA OF THE LEFT ANTERIOR AND MIDDLE CEREBRAL ARTERY TERRITORY. MAGNETIC RESONANCE ANGIOGRAPHY (MRA) DEMONSTRATED NO FLOW IN THE LEFT TERMINAL ICA, THE ANEURYSM, AND LEFT MIDDLE CEREBRAL ARTERY. THE PATIENT GRADUALLY STABILIZED AND WAS TRANSFERRED TO A REHABILITATION CENTER. IT WAS REPORTED BY THE PHYSICIAN THAT THE CASE WAS VERY DIFFICULT AND THE OUTCOME WAS NOT DUE TO A PROBLEM WITH THE ENTERPRISE VRD. THE PATIENT INITIALLY PRESENTED WITH LEFT RETRO-ORBITAL PAIN AND DIPLOPIA OF THE LEFT EYE. SHE HAD PROMINENT PALSY OF THE LEFT ABDUCING NERVE. CT AND CT ANGIOGRAPHY DISCLOSED A LARGE UNRUPTURED ANEURYSM OF THE C7 SEGMENT OF THE LEFT ICA (20MM IN SIZE AND 7MM NECK) AND SHE WAS REFERRED TO ENDOVASCULAR TREATMENT. AFTER DUAL ANTIPLATELET PREPARATION, THE NECK OF THE ANEURYSM WAS BRIDGED BY FOUR CLOSED-CELL STENTS IN A STENT-IN-STENT CONFIGURATION (TWO 4.5X22MM ENTERPRISE STENTS, ONE 4.5X14MM ENTERPRISE STENT AND ONE 4.5X25MM LEO STENT) WITH IMMEDIATE SLOWING OF THE BLOOD FLOW IN THE ANEURYSM WITH NARROWER INFLOW AND IMPROVED DISTAL FLOW. THE VESSEL MEASURED 3.7MM PROXIMALLY AND 4MM DISTALLY. THERE WERE NO INTRA-PROCEDURAL COMPLICATIONS, AND THE PATIENT WAS KEPT ON DUAL ANTIPLATELET MEDICATIONS. IN THE ARTICLE IS IT SPECULATED THAT THE CAUSE OF RUPTURE MAY HAVE BEEN A CHANGED DIRECTION AND NARROWING OF BLOOD INFLOW, SINCE THE COMPUTATIONAL DYNAMICS OF IN VIVO INTRAANEURYSMALISMAL FLOW SHOWED THAT RUPTURED ANEURYSMS MAY HAVE A CHANGING REGION OF IMPINGEMENT AS WELL AS NARROWER INFLOW JETS COMPARED TO UNRUPTURED ONES. THE SIZE OF THE ANEURYSM, 20MM IN THIS PATIENT INEVITABLY STRETCHES THE WALL OF THE ANEURYSM, MAKING IT THIN AND INFLEXIBLE. THEREFORE, IT IS MORE VULNERABLE TO RUPTURE BY THE SUDDENLY NARROWED INFLOW JET OF BLOOD, WHICH IS DIRECTED TO A DIFFERENT PART OF THE ANEURYSM AS A RESULT OF STENTS AT THE ORIFICE OF THE ANEURYSM. AT FINAL ANGIOGRAMS AT THE END OF THE PROCEDURE, THE INFLOW JETS WAS ORIENTED SLIGHTLY MORE DISTALLY AT THE UPPER PORTION OF THE ANEURYSM, COMPARED TO PRETREATMENT ANGIOGRAMS, SUPPORTING THIS HYPOTHESIS. IT WAS REPORTED THAT THE OTHER FACTOR WHICH SHOULD BE CONSIDERED IS THE OUTFLOW FROM THE ANEURYSM, WHICH IS MOST PROBABLY REDUCED AS WELL, AND MAY BE SEEN ANGIOGRAPHICALLY AS THE RETENTION OF CONTRAST IN THE ANEURYSM. ALTHOUGH IT SUGGESTS SLOWING OF THE INTRAANEURYSMAL BLOOD FLOW WHICH PROMOTES THROMBOSIS, IT MAY BE DANGEROUS IF COMBINED WITH PERSISTENT AND NARROWER INFLOW JET. THE SUBSEQUENT RISE OF INTRAANEURYSMAL PRESSURE MAY RESULT IN RUPTURE. IN THIS CASE, THERE WERE SIGNS OF BLEEDING AS WELL AS A LARGE ISCHEMIC INFARCTION. THE AUTHORS SPECULATE THAT THE ANEURYSM RUPTURED, AND SUBSEQUENTLY, THE FORMATION OF THROMBUS OCCLUDED BOTH THE ANEURYSM AND THE PARENT ARTERY, CAUSING ISCHEMIA. IN ADDRESSING ANTIPLATELET MEDICATION AND THE RISK OF HEMORRHAGE, THE AUTHORS STATE THAT STENTING IS PROPOSED TO PROMOTE ANEURYSM THROMBOSIS BY REDISTRIBUTION OF FLOW AWAY FROM THE ANEURYSM BY BRIDGING OF THE DISEASED VESSEL WALL AT THE ANEURYSM NECK AND BY THE CHANGE OF ARTERIAL ANGLE WHILE AT THE SAME TIME PRESERVING PERFORATING ARTERIES BY THE POROSITY OF THE STENT. AT THE SAME TIME, THE PROCESS OF ANEURYSM THROMBOSIS MAY BE HAMPERED BY THE ANTIPLATELET THERAPY WITH THIS TECHNIQUE OF STENTING WITHOUT COILING. THE STENTS REMAIN IMPLANTED AND THE LOT NUMBERS ARE NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. AS REPORTED BY THE AUTHORS, THE TECHNIQUE OF STENT WITHIN STENT PLACEMENT ACROSS THE NECK OF THE ANEURYSM WITHOUT COIL PLACEMENT MAY RESULT CHANGES IN BLOOD FLOW AND A NARROWER INFLOW JET WITH INCREASED PRESSURE IN THE LARGE THIN WALLED ANEURYSM WHICH MAY HAVE CONTRIBUTED TO THE ANEURYSM RUPTURE FOLLOWED BY FORMATION OF VESSEL OCCLUDING THROMBUS. THE INSTRUCTIONS FOR USE OUTLINES THAT THE ENTERPRISE VRD IS INTENDED FOR USE WITH EMBOLIC COILS FOR THE TREATMENT OF WIDE-NECK, INTRACRANIAL, SACCULAR OR FUSIFORM ANEURYSMS. IT ALSO PRECAUTIONS THAT THE PERFORMANCE AND SAFETY OF TWO OR MORE OVERLAPPED STENTS HAS NOT BEEN ESTABLISHED. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. BASED ON THE AVAILABLE INFORMATION AND AS PER THE REPORTER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE POST PROCEDURE SUBARACHNOID HEMORRHAGE AND CEREBRAL ISCHEMIA. BASED ON THE REPORTED INFORMATION AND AS PER THE PHYSICIAN, THERE IS NO INDICATION THAT THE EVENT IS RELATED A DEVICE MALFUNCTION, OR TO THE ENTERPRISE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTATIVE 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 MFG REPORT #1058196-2010-00051, 1058196-2010-00052, & 1058196-2010-00053.

    Description of Event or Problem · 1

    AS PUBLISHED IN THE 01/27/2010 ONLINE EDITION OF ACTA NEUROCHIR DOI 10.1007/S00701-009-0592-Y IN "SOLE STENTING OF LARGE AND GIANT INTRACRANIAL ANEURYSMS WITH SELF-EXPANDING INTRACRANIAL STENTS-LIMITS AND COMPLICATIONS" 24 HOURS AFTER A (B) (6) FEMALE PT WAS TREATED WITH 3 ENTERPRISE STENTS, SHE DEVELOPED SUDDEN RIGHT HEMIPARESIS AND LOST CONSCIOUSNESS. CT SCAN REVEALED ACUTE SUBARACHNOID HEMORRHAGE AND AN ACUTE ISCHEMIA IN THE LEFT ANTERIOR AND MIDDLE CEREBRAL ARTERY TERRITORY. AT MAGNETIC RESONANCE (MR) ANGIOGRAPHY, THERE WAS NO FLOW IN THE LEFT TERMINAL ICA, THE ANEURYSM, AND LEFT MIDDLE CEREBRAL ARTERY. THE PT GRADUALLY STABILIZED AND WAS TRANSFERRED TO A REHABILITATION CENTER. THE PT INITIALLY PRESENTED WITH LEFT RETRO-ORBITAL PAIN AND DIPLOPIA OF THE LEFT EYE. SHE HAD PROMINENT PALSY OF THE LEFT ABDUCING NERVE. CT AND CT ANGIOGRAPHY DISCLOSED A LARGE UNRUPTURED ANEURYSM OF THE C7 SEGMENT OF THE LEFT ICA (20 MM IN SIZE AND 7 MM NECK) AND SHE WAS REFERRED TO ENDOVASCULAR TREATMENT. AFTER DUAL ANTIPLATELET PREPARATION, THE NECK OF THE ANEURYSM WAS BRIDGED BY FOUR CLOSED-CELL STENTS IN A STENT-IN-STENT CONFIGURATION (TWO 4.5X22 MM ENTERPRISE STENTS, ONE 4.5X14 MM ENTERPRISE STENT, AND ONE 4.5X25 MM LEO STENT) WITH IMMEDIATE SLOWING OF THE BLOOD FLOW IN THE ANEURYSM WITH NARROWER INFLOW AND IMPROVED DISTAL FLOW. THERE WERE NO INTRA-PROCEDURAL COMPLICATIONS, AND THE PT WAS KEPT ON DUAL ANTIPLATELET MEDICATIONS. ADD'L INFO INDICATED THAT THE VESSEL MEASURED PROXIMALLY 3.7 MM AND DISTALLY 4 MM. THE CURRENT PT STATUS IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THE FOWLER WAS DRIFTING.

    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. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R