BEUDAMED
    FDA Adverse Event Death Summary report: N

    TREVO XP PROVUE RETRIEVER 3X20

    MDR report key: 6087167 · Received November 8, 2016

    Report

    Report Number
    0002954917-2016-00159
    Event Type
    Death
    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

    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, HEMORRHAGE AND DEATH, 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.

    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 3 OF 6 REPORTS FOR THIS ARTICLE. DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THIS ARTICLE PROVIDED 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 # 9: MECHANICAL THROMBECTOMY USING THE SUBJECT RETRIEVAL DEVICE WAS PERFORMED TO REMOVE THE CLOT FORM THE MCA M1. AFTER TWO PASSES WITH THE SUBJECT RETRIEVAL DEVICE VESSEL PERFORATION OCCURRED AT MIDDLE CEREBRAL ARTERY (MCA) M2 RESULTING IN A SAH (SUBARACHNOID HEMORRHAGE). INFLATION OF INTRACRANIAL BALLOON WAS PERFORMED AS A RESCUE ENDOVASCULAR TREATMENT AND PATIENT ACHIEVED TICI (THROMBOLYSIS IN CEREBRAL INFARCTION) SCORE OF 2A. AT 3 MONTHS OF FOLLOW UP THE PATIENT DIED (MRS (MODIFIED RANKIN SCALE) OF 6). NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THIS ARTICLE PROVIDED 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 (B)(6) 2012 AND (B)(6) 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 # 9 (TABLE 2): MECHANICAL THROMBECTOMY USING THE SUBJECT RETRIEVAL DEVICE WAS PERFORMED TO REMOVE THE CLOT FORM THE MCA M1. AFTER TWO PASSES WITH THE SUBJECT RETRIEVAL DEVICE VESSEL PERFORATION OCCURRED AT MIDDLE CEREBRAL ARTERY (MCA) M2 RESULTING IN A SAH (SUBARACHNOID HEMORRHAGE). INFLATION OF INTRACRANIAL BALLOON WAS PERFORMED AS A RESCUE ENDOVASCULAR TREATMENT AND PATIENT ACHIEVED TICI (THROMBOLYSIS IN CEREBRAL INFARCTION) SCORE OF 2A. AT 3 MONTHS OF FOLLOW UP THE PATIENT DIED (MRS (MODIFIED RANKIN SCALE) OF 6). NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738780 TREVO XP PROVUE RETRIEVER 3X20 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O| R