BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREVO XP PROVUE RETRIEVER 4X20

    MDR report key: 6909747 · Received October 3, 2017

    Report

    Report Number
    0002954917-2017-00089
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    December 9, 2016
    Report Date
    December 7, 2017
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K132641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE EXECUTIVE SUMMARY WAS UPDATED TO REFLECT ADDITIONAL INFORMATION RECEIVED FROM THE STUDY FACILITY INDICATING THAT DURING PULLING BACK OF THE STENT RETRIEVER AND TRACTION MECHANISM WITH THE 5MAX ACE ASPIRATION CATHETER CAUSED THE VESSEL PERFORATION AND DEVELOPMENT OF THE SAH. HOWEVER, NO DIFFICULTY DURING DRIVING OF THE STENT RETRIEVER OR SET UP WAS ENCOUNTERED. IN ADDITION, THE STUDY FACILITY INDICATED THAT THE ACTILYSE MEDICATION BEING ADMINISTERED DURING THE PROCEDURE WAS STOPPED, BUT TREATMENT WAS NOT ADMINISTERED. THE PATIENT NIHSS CONTINUED TO INCREASED FROM 10, TO 14 AND 21 POST PROCEDURE. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. HOWEVER, VESSEL PERFORATION AND INTRACRANIAL HEMORRHAGE ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE NOTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE TO RESTORE BLOOD FLOW TO THE OCCLUDED RIGHT MCA-M2 SEGMENT, VESSEL PERFORATION AND SUBARACHNOID HEMORRHAGE OCCURRED. POST PROCEDURE THE PATIENT WAS ASSESSED HAVING A TICI OF 2B. AT APPROXIMATELY 24 HOURS POST PROCEDURE THE PATIENT WAS ASSESSED HAVING A NIHSS OF 7. THE VESSEL PERFORATION WAS REPORTED TO HAVE RESOLVED. THE SUBARACHNOID HEMORRHAGE (SAH) RESOLVED WITH MEDICAL MANAGEMENT. THE VESSEL PERFORATION AND SAH WERE REPORTED TO HAVE RESOLVED APPROXIMATELY 4 DAYS POST THE INDEX PROCEDURE. THE PATIENT WAS ASSESSED HAVING A NIHSS OF 10 AND WAS DISCHARGED TO ANOTHER GENERAL HOSPITAL APPROXIMATELY 6 DAYS POST THE INDEX PROCEDURE. THE STUDY FACILITY REPORTED THAT THE VESSEL PERFORATION AND SAH WERE RELATED TO THE PROCEDURE AND THE RETRIEVER DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE TO RESTORE BLOOD FLOW TO THE OCCLUDED RIGHT MCA-M2 SEGMENT, VESSEL PERFORATION AND SUBARACHNOID HEMORRHAGE OCCURRED. THE PHYSICIAN¿S BELIEVED THAT THE 5MAX ACE ASPIRATION CATHETER AND THE TRACKING MOVEMENT ON THE RIGHT MCA CAUSED THE HEMORRHAGE. POST PROCEDURE THE PATIENT WAS ASSESSED HAVING A TICI OF 2B. AT APPROXIMATELY 24 HOURS POST PROCEDURE THE PATIENT WAS ASSESSED HAVING A NIHSS OF 7. THE VESSEL PERFORATION WAS REPORTED TO HAVE RESOLVED. THE SUBARACHNOID HEMORRHAGE (SAH) RESOLVED WITH MEDICAL MANAGEMENT. THE VESSEL PERFORATION AND SAH WERE REPORTED TO HAVE RESOLVED APPROXIMATELY 4 DAYS POST THE INDEX PROCEDURE. TRANSIENT WORSENING OF CLINICAL STATUS OF THE PATIENT OCCURRED. THE PATIENT WAS ASSESSED HAVING A NIHSS OF 10 AND WAS DISCHARGED TO ANOTHER GENERAL HOSPITAL APPROXIMATELY 6 DAYS POST THE INDEX PROCEDURE. THE STUDY FACILITY REPORTED THAT THE VESSEL PERFORATION AND SAH WERE RELATED TO THE PROCEDURE AND THE RETRIEVER DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE TO RESTORE BLOOD FLOW TO THE OCCLUDED RIGHT MCA-M2 SEGMENT, VESSEL PERFORATION AND SUBARACHNOID HEMORRHAGE (SAH) OCCURRED. THE PHYSICIAN¿S BELIEVED THAT WHEN PULLING BACK THE STENT RETRIEVER ALONG WITH TRACTION MECHANISM WITH THE 5MAX ACE ASPIRATION CATHETER CAUSED THE VESSEL PERFORATION AND DEVELOPMENT OF THE SAH. HOWEVER, THERE WAS NO DIFFICULTY OF STENT DRIVING OR SET UP. THERE WAS NO MEDICAL TREATMENT ADMINISTERED EXCEPT THAT THE PHYSICIAN STOPPED THE ACTILYSE MEDICATION BEING ADMINISTERED DURING ONGOING PROCEDURE. POST PROCEDURE THE PATIENT WAS ASSESSED HAVING A TICI OF 2B. AT APPROXIMATELY 24 HOURS POST PROCEDURE THE PATIENT WAS ASSESSED HAVING A NIHSS OF 7. THE VESSEL PERFORATION WAS REPORTED TO HAVE RESOLVED. THE SUBARACHNOID HEMORRHAGE (SAH) RESOLVED WITH MEDICAL MANAGEMENT (SYMPTOMATIC - (HEADACHE) + VASOSPASM PREVENTION). THE VESSEL PERFORATION AND SAH WERE REPORTED TO HAVE RESOLVED APPROXIMATELY 4 DAYS POST THE INDEX PROCEDURE. TRANSIENT WORSENING OF CLINICAL STATUS OF THE PATIENT OCCURRED. THE PATIENT WAS ASSESSED HAVING A NIHSS OF 10, 14, 21 AND WAS DISCHARGED TO ANOTHER GENERAL HOSPITAL APPROXIMATELY 6 DAYS POST THE INDEX PROCEDURE. THE STUDY FACILITY REPORTED THAT THE VESSEL PERFORATION AND SAH WERE RELATED TO THE PROCEDURE, 5MAX ACE ASPIRATION CATHETER AND THE STENT RETRIEVER DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690484 TREVO XP PROVUE RETRIEVER 4X20 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL 60088

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| R