BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3853860 · Received June 6, 2014

    Report

    Report Number
    1058196-2014-00171
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 16, 2014
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED DESCRIPTION AND CONCLUSION FOLLOWING ADDITIONAL INFORMATION RECEIVED 6/3/2014: INFORMATION WAS RECEIVED REPORTING THAT THERE WAS OVERLAPPING OF THE DISTAL MARKERS OF AN ENTERPRISE VRD ((ENC452800/10237961) NOTED APPROXIMATELY 7 MONTHS POST IMPLANTATION OF THIS STENT AND OVERLAPPING STENT WITHIN STENT PLACEMENT OF TWO OTHER ENTERPRISE VRDS (ENC452212/10241263 & (ENC452212/10234501). ADDITIONALLY, IT WAS REPORTED THAT THERE WAS STENOSIS NOTED AT THE DISTAL END OF THE DISTAL ENTERPRISE AND THAT THE INCOMPLETE DEPLOYMENT OF THE MARKERS OF THE FIRST STENT WAS POSSIBLY DUE TO SPASM AND FORWARD MOVEMENT OF THE STENT. THE DISTANCE OF THE STENOSIS FROM THE OTHER TWO STENTS IS NOT KNOWN. THE PATIENT UNDERWENT COIL EMBOLIZATION OF A 1-2MM INTERNAL CAROTID ARTERY ANEURYSM TWO WEEKS AFTER ADMISSION WITH A SUBARACHNOID HEMORRHAGE (SAH). THE FIRST ENTERPRISE VRD WAS PLACED BETWEEN THE ICA AND MCA ACROSS THE TARGET ANEURYSM FOLLOWED BY COIL EMBOLIZATION. THEN WHEN PLACING THE FIRST UNKNOWN 2MM COIL VIA AN UNKNOWN MICROCATHETER VIA A JAILED TECHNIQUE THE MICROCATHETER LOST TARGET POSITION; THEREFORE THE MICROCATHETER WAS RE-NAVIGATED INTO THE TARGET ANEURYSM VIA A TRANS-CELL TECHNIQUE. IT WAS THEN DETERMINED THAT THE COIL WAS NOT THE PROPER SIZE AND ANOTHER UNKNOWN 1.5MM COIL WAS PLACED; HOWEVER, IT PROTRUDED OUT OF THE ANEURYSM. FOLLOW-UP INFORMATION THEN REPORTED THAT SHORTLY AFTER COIL PLACEMENT, IT WAS NOTED THAT A PERFORATION OF THE TARGET ANEURYSM HAD OCCURRED. ADDITIONAL COIL EMBOLIZATION WAS PERFORMED TO STOP BLEEDING INTO THE ANEURYSM. A SECOND ENTERPRISE VRD (ENC452212/10241263) WAS NAVIGATED TO COVER THE ANEURYSM NECK THROUGH THE FIRST ENTERPRISE VRD STRUT AND DEPLOYED WITH THE DISTAL END OF THE 2ND VRD AND THE PROXIMAL PORTION OVERLAPPING THE FIRST STENT. A THIRD ENTERPRISE VRD (ENC452212/10234501) WAS ALSO PLACED AT THE PROXIMAL PORTION OF THE 2ND VRD. THE ENTIRE ANEURYSM NECK WAS COVERED WITH THREE ENTERPRISE VRDS. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. NO PATIENT INJURY/COMPLICATIONS WERE REPORTED AT THAT TIME. IT IS UNKNOWN HOW MANY COILS WERE SUCCESSFULLY PLACED INTO THE ANEURYSM DURING THE PROCEDURE. AT FOLLOW-UP APPROXIMATELY 7 MONTHS LATER ANGIOGRAM REVEALED THAT THE DISTAL MARKERS OF THE FIRST ENTERPRISE LOCATED IN THE MCA WERE NOT COMPLETELY DEPLOYED; THEY OVERLAPPED EACH OTHER. ADDITIONALLY THE PARENT VESSEL, THE MCA, WHERE THE DISTAL STENT MARKERS OF THE VRD WERE LOCATED APPEARED TO BE NARROWED. ACCORDING TO THE PHYSICIAN, THE DISTAL STENT MARKERS OF THE VRD MIGHT HAVE BEEN OVERLAPPED SINCE THE INDEX PROCEDURE. IT WAS REPORTED THAT SPASM MIGHT HAVE BEEN PRODUCED BY PHYSICAL CONTACT WITH UNSPECIFIED DEVICES DURING THE PROCEDURE WITH THE VRD PUSHED DISTALLY AND ITS DISTAL STENT MARKERS GETTING STUCK SOMEWHERE WITHIN THE PARENT VESSEL. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE BUT TO THE ENTERPRISE IS UNKNOWN IT WAS REPORTED THAT THE PHYSICIAN CONSIDERED THAT THE STENOSIS WAS RELATED TO THE FIRST STENT IMPLANTED; HOWEVER, IT IS NOT KNOWN IF THE DISTAL END OF THE SECOND STENT WAS 5MM BEYOND THE STENOSIS. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOTS OF THE THREE INVOLVED ENTERPRISE VRDS. THE DEVICE HISTORY RECORD REVIEWS 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 LOTS. THE HISTORY RECORDS INDICATE THESE PRODUCTS WERE FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WERE DETERMINED TO BE ACCEPTABLE. AFTER THREE ENTERPRISE VRDS WERE IMPLANTED OVERLAPPING ONE INSIDE THE OTHER TO COVER THE NECK OF A 1-2MM ANEURYSM THERE WAS STENOSIS AT THE DISTAL END OF THE MOST DISTAL STENT. THE RELATIONSHIP AND PROXIMITY TO THE OTHER TWO STENTS IS NOT KNOWN. IT APPEARS THAT THE STENT WITHIN STENT PLACEMENT MAY HAVE BEEN TO ASSIST WITH FLOW DIVERSION INTO THE ANEURYSM. THIS USAGE IS NOT INDICATED IN THE IFU. IT IS LISTED IN THE INSTRUCTIONS FOR USE PRECAUTIONS THAT THE ENTERPRISE VRD IS NOT INTENDED FOR USE AS A STAND-ALONE DEVICE, I.E. WITHOUT SUBSEQUENT COIL EMBOLIZATION OF THE ANEURYSM. IN ADDITION THE IFU 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. ADDITIONALLY IT WAS REPORTED THAT SPASM DUE TO CONTACT WITH UNIDENTIFIED DEVICES DURING THE PROCEDURE MAY HAVE LED TO FORWARD MOVEMENT OF THE STENT, POSSIBLY CONTRIBUTING TO THE DISTAL MARKERS OF THE FIRST STENT NOT BEING FULLY DEPLOYED/EXPANDED. VASOSPASM AS A RESULT OF DIRECT PHYSICAL IRRITATION OF THE ENDOTHELIUM IS A KNOWN POTENTIAL OCCURRENCE DURING ENDOVASCULAR PROCEDURES AND IS OUTLINED IN THE INSTRUCTIONS FOR USE AS SUCH. ADDITIONALLY, THE PATIENT HAD BEEN ADMITTED WITH A SAH TWO WEEKS PRIOR TO THE INDEX PROCEDURE. VASOSPASM IS A COMMON COMPLICATION OF SAH, REPORTED TO OCCUR IN AS MANY AS 70% OF PATIENTS WITH SAH AND MOST COMMONLY, THIS OCCURS 4-14 DAYS AFTER THE HEMORRHAGE. STENOSIS IS A KNOWN POTENTIAL COMPLICATION RELATED TO ENDOVASCULAR STENTING AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE AVAILABLE REPORTED INFORMATION, THERE ARE PROCEDURAL AND PATIENT FACTORS ADDRESSED IN THE LABELING THAT APPEAR TO HAVE CONTRIBUTED TO THE EVENTS WITH NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT BOTH THE SECOND AND THIRD VRD WERE DEPLOYED TO PREVENT THE PROTRUSION OF THE IMPLANTED COIL (TARGET/STRYKER, SIZE 1.5MM). A 2ND ENTERPRISE (ENC452212/10241263) WAS NAVIGATED TO COVER THE NECK OF THE 1ST VRD STRUT AND DEPLOYED OVERLAPPING AND PROXIMAL TO THE FIRST STENT. A 3RD ENTERPRISE (ENC452212/10241263) WAS DEPLOYED PROXIMAL TO AND OVERLAPPING THE 2ND ENTERPRISE. THE ENTIRE NECK WAS COVERED WITH THE 3 ENTERPRISE VRDS. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. NO PATIENT INJURY/COMPLICATIONS WERE REPORTED AT THAT TIME. IT IS UNKNOWN HOW MANY COILS WERE SUCCESSFULLY PLACED INTO THE ANEURYSM DURING THE PROCEDURE. WITH ANGIOGRAPHIC FOLLOW-UP 2 MONTHS AFTER THE PROCEDURE THE DISTAL STENT MARKERS OF THE 1ST VRD (ENC452800/10237961) LOCATED IN THE MCA OVERLAPPED WITH EACH OTHER AND THE PARENT VESSEL WHERE THE DISTAL STENT MARKERS OF THE VRD WERE LOCATED APPEARED TO BE NARROWED. AT THE FOLLOW-UP APPROXIMATELY 7 MONTHS LATER, THE ANGIOGRAM REVEALED THAT THE DISTAL STENT MARKERS OF THE 1ST VRD LOCATED IN MIDDLE CEREBRAL ARTERY WERE NOT COMPLETELY DEPLOYED (OPEN). STENOSIS WAS CONFIRMED IN THE PARENT VESSEL DISTAL TO THE 1ST VRD. THE VRD POSITION HAS BEEN STABLE. DURING THIS TIME, ANTIPLATELET THERAPY INCLUDED ASPIRIN AND CLOPIDOGREL SULFATE HAVE BEEN ADMINISTERED. NO INFORMATION REGARDING THE DOSAGE AND START DATE OF THE ANTIPLATELET THERAPY. THE PATIENT HAS BEEN FOLLOWED UP BUT NO PATIENT INJURY/COMPLICATIONS WERE REPORTED FOR NOW. THE PATIENT HAS BEEN FOLLOWED UP BUT NO PATIENT INJURY/COMPLICATIONS WERE REPORTED FOR NOW. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE BUT TO THE VRD WAS UNKNOWN. THERE IS NO INFORMATION REGARDING THE SIZE OF THE ANEURYSM AND VESSEL, ANTIPLATELET THERAPY, MRS, INR, PT AND PTT WAS PROVIDED. ALSO THE OCCLUSION RATE OF THE ANEURYSM AFTER THE PROCEDURE WAS UNKNOWN. THE ENTERPRISE VRDS WERE NEW AND STORED PER LABELING INSTRUCTION. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCTS BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE DEVICES ARE UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. THIS IS REPORT 1 OF 3 RELATED TO (B)(4).

    Description of Event or Problem · 1

    AN ENTERPRISE STENT ASSISTED COIL EMBOLIZATION OF A 1-2 MM LEFT INTERNAL CAROTID ARTERY ANEURYSM (ICA) WAS PERFORMED WITH INITIAL PLACEMENT OF THE FIRST 28MM ENTERPRISE (ENC452800/10237961) FOLLOWED BY PLACEMENT OF TWO OTHER 22MM ENTERPRISE VRDS (ENC452212/10241263) AND (ENC452212/10241263) TO PREVENT PROTRUSION OF AN IMPLANTED 1.5MM TARGET/STRYKER COIL. IT WAS FURTHER REPORTED THAT AT FOLLOW-UP THE DISTAL MARKERS OF THE FIRST ENTERPRISE WERE NOT COMPLETELY DEPLOYED (OPEN). STENOSIS WAS CONFIRMED IN THE PARENT VESSEL DISTAL TO THE 1ST VRD. IT HASN¿T VERIFIED, BUT ACCORDING TO THE PHYSICIAN, THE DISTAL STENT MARKERS OF THE VRD MIGHT HAVE BEEN OVERLAPPED SINCE THE INDEX PROCEDURE AS SPASM MIGHT HAVE BEEN PRODUCED BY PHYSICAL CONTACT WITH UNSPECIFIED DEVICES DURING THE PROCEDURE, THE VRD WAS PUSHED DISTALLY AND ITS DISTAL STENT MARKERS GOT STUCK SOMEWHERE WITHIN THE PARENT VESSEL. THUS, THE PHYSICIAN CONSIDERED THAT THE DISTAL STENT MARKERS OF THE VRD WERE OVERLAPPED WITH EACH OTHER AND THE STENOSIS MIGHT HAVE BEEN CAUSED BY THE EVENT. THERE IS NO INFORMATION ABOUT THE OTHER DEVICES UTILIZED DURING THE PROCEDURE OR THE IMPLANTED COILS. THE PATIENT WAS ADMITTED WITH A SUBARACHNOID HEMORRHAGE TWO WEEKS PRIOR TO THE INDEX PROCEDURE. THE FIRST ENTERPRISE WAS PLACED BETWEEN THE ICA AND MIDDLE CEREBRAL ARTERY (MCA) ACROSS THE TARGET ANEURYSM. WHILE PLACING AN UNSPECIFIED COIL 2MM INTO THE ANEURYSM USING A JAILED MICROCATHETER TECHNIQUE; THE UNKNOWN MICROCATHETER LOST TARGET POSITION. THE MICROCATHETER WAS AGAIN NAVIGATED INTO THE TARGET ANEURYSM USING A TRANS-CELL TECHNIQUE; HOWEVER, THE COIL SIZE WAS NOT PROPER FOR THE TARGET LESION, THEREFORE IT WAS REPLACED WITH A DIFFERENT 1.5MM TARGET/STRYKER COIL. SHORTLY AFTER, IT WAS NOTED THAT A PERFORATION OF THE TARGET ANEURYSM OCCURRED. ADDITIONAL EMBOLIZATION WAS PERFORMED TO STOP THE BLEEDING INTO THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332746 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 10237961

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R| S