BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREVO XP PROVUE RETRIEVER 3X20

    MDR report key: 6087756 · Received November 8, 2016

    Report

    Report Number
    0002954917-2016-00160
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    September 1, 2016
    Report Date
    February 1, 2017
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K132641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. ALL PATIENTS WERE TREATED BETWEEN MARCH 2012 AND MARCH 2016. THIS IS 2 OF 6 REPORTS FOR THIS ARTICLE. DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, VESSEL PERFORATION AND HEMORRHAGE, ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS WAS ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    THIS ARTICLE PROVIDES THE RESULTS OF RETROSPECTIVE THE STUDY WHICH WAS CONDUCTED TO REPORT ON SERIES OF PATIENTS WHOSE STENT RETRIEVER THROMBECTOMY WAS COMPLICATED BY INTRAPROCEDURAL VESSEL PERFORATION AND DISCUSS ITS POTENTIAL MECHANISMS, RESCUE TREATMENT STRATEGIES AND CLINICAL SIGNIFICANCE. A TOTAL OF 1599 PATIENTS FROM NINE STROKE CENTERS WERE TREATED WITH INTRA-ARTERIAL THROMBECTOMY USING STENT RETRIEVERS BETWEEN MARCH 2012 AND MARCH 2016. INTRAPROCEDURAL VESSEL PERFORATION DURING STENT RETRIEVER THROMBECTOMY OCCURRED IN 1.0% (16/ 1599) OF PATIENTS. VESSEL PERFORATION OCCURRED IN MOST CASES AT DISTAL LOCATIONS: MIDDLE CEREBRAL ARTERY (MCA) M2, ANTERIOR CEREBRAL ARTERY A2 AND POSTERIOR CEREBRAL ARTERY P2/3. ENDOVASCULAR RESCUE TECHNIQUES (MOST COMMONLY, INTRACRANIAL BALLOON OCCLUSION FOR TAMPONADE) WERE ATTEMPTED IN 50% OF CASES. PROCEDURE WAS ABORTED WITHOUT ANY RESCUE ATTEMPTS IN 44% OF CASES. MORTALITY DURING HOSPITALIZATION AND AT 3 MONTHS WAS 56% AND 63%, RESPECTIVELY. THE 25% OF PATIENTS ACHIEVED GOOD RESULTS. PATIENT #8 (TABLE2): MECHANICAL THROMBECTOMY USING THE SUBJECT RETRIEVAL DEVICE WAS PERFORMED TO REMOVE THE CLOT FROM THE MIDDLE CEREBRAL ARTERY (MCA) M2 UNDER GENERAL ANESTHESIA. AFTER TWO PASSES WITH THE SUBJECT RETRIEVAL DEVICE A TREATED VESSEL PERFORATION OCCURRED RESULTING IN A SAH (SUBARACHNOID HEMORRHAGE). MEDICAL THERAPY (UNSPECIFIED) WAS GIVEN FOR THE REVERSAL OF THE ELEVATED INR (INTERNATIONAL NORMALIZED RATIO) AND THE PROCEDURE WAS ABORTED HOWEVER, PATIENT ACHIEVED TICI (THROMBOLYSIS IN CEREBRAL INFARCTION) SCORE OF 2A. THE SUSPECTED CAUSE IN THIS CASE WAS "HARD CLOT". AT 3 MONTHS OF FOLLOW UP THE PATIENT HAD MRS (MODIFIED RANKIN SCALE) OF 5. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THIS ARTICLE PROVIDES THE RESULTS OF RETROSPECTIVE THE STUDY WHICH WAS CONDUCTED TO REPORT ON SERIES OF PATIENTS WHOSE STENT RETRIEVER THROMBECTOMY WAS COMPLICATED BY INTRAPROCEDURAL VESSEL PERFORATION AND DISCUSS ITS POTENTIAL MECHANISMS, RESCUE TREATMENT STRATEGIES AND CLINICAL SIGNIFICANCE. A TOTAL OF 1599 PATIENTS FROM NINE STROKE CENTERS WERE TREATED WITH INTRA-ARTERIAL THROMBECTOMY USING STENT RETRIEVERS BETWEEN MARCH 2012 AND MARCH 2016. INTRAPROCEDURAL VESSEL PERFORATION DURING STENT RETRIEVER THROMBECTOMY OCCURRED IN 1.0% (16/ 1599) OF PATIENTS. VESSEL PERFORATION OCCURRED IN MOST CASES AT DISTAL LOCATIONS: MIDDLE CEREBRAL ARTERY (MCA) M2, ANTERIOR CEREBRAL ARTERY A2 AND POSTERIOR CEREBRAL ARTERY P2/3. ENDOVASCULAR RESCUE TECHNIQUES (MOST COMMONLY, INTRACRANIAL BALLOON OCCLUSION FOR TAMPONADE) WERE ATTEMPTED IN 50% OF CASES. PROCEDURE WAS ABORTED WITHOUT ANY RESCUE ATTEMPTS IN 44% OF CASES. MORTALITY DURING HOSPITALIZATION AND AT 3 MONTHS WAS 56% AND 63%, RESPECTIVELY. 25% OF PATIENTS ACHIEVED GOOD RESULTS. PATIENT #8 (TABLE2): MECHANICAL THROMBECTOMY USING THE SUBJECT RETRIEVAL DEVICE WAS PERFORMED TO REMOVE THE CLOT FROM THE MIDDLE CEREBRAL ARTERY (MCA) M2 UNDER GENERAL ANESTHESIA. AFTER TWO PASSES WITH THE SUBJECT RETRIEVAL DEVICE A TREATED VESSEL PERFORATION OCCURRED RESULTING IN A SAH (SUBARACHNOID HEMORRHAGE). MEDICAL THERAPY (UNSPECIFIED) WAS GIVEN FOR THE REVERSAL OF THE ELEVATED INR (INTERNATIONAL NORMALIZED RATIO) AND THE PROCEDURE WAS ABORTED HOWEVER, PATIENT ACHIEVED TICI (THROMBOLYSIS IN CEREBRAL INFARCTION) SCORE OF 2A. THE SUSPECTED CAUSE IN THIS CASE WAS ¿HARD CLOT¿. AT 3 MONTHS OF FOLLOW UP THE PATIENT HAD MRS (MODIFIED RANKIN SCALE) OF 5. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736811 TREVO XP PROVUE RETRIEVER 3X20 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R