BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFLEX CATHETER

    MDR report key: 19140223 · Received April 18, 2024

    Report

    Report Number
    2029214-2024-00697
    Event Type
    Death
    Date Received
    April 18, 2024
    Date of Event
    November 9, 2022
    Report Date
    April 18, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE SEE ATTACHMENTS FOR LITERATURE ARTICLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    W. ZHONG, T. ZHANG, C. SU, D. ZHOU, J. ZHUANG, M. LI, Y. XU, M. LIU, M. ZHANG, Y. WANG, D. WANG, W. SU; JOURNAL OF NEUROINTERVENTIONAL SURGERY; 2023; 15:1194¿1200; RECONSTRUCTIVE ENDOVASCULAR TREATMENT FOR BASILAR ARTERY TRUNK ANEURYSMS: COMPLICATIONS AND CLINICAL AND ANGIOGRAPHY OUTCOMES; DOI:10.1136/JNIS-2022-019864 MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE THAT PATIENTS TREATED WITH SOLITAIRE STENTS, PIPELINE FLOW DIVERTERS, AND NAVIEN CATHETERS POSSIBLY HAD COMPLICATIONS. THE PURPOSE OF THE ARTICLE WAS TO INVESTIGATE THE PROCEDURAL COMPLICATIONS AND CLINICAL AND ANGIOGRAPHIC OUTCOMES OF BASILAR ARTERY TRUNK ANEURYSMS (BTAS) TREATED WITH RECONSTRUCTIVE ENDOVASCULAR TREATMENT (EVT). THEY RETROSPECTIVELY REVIEWED THE DATA OF 111 PATIENTS WITH BTAS WHO UNDERWENT RECONSTRUCTIVE EVT DURING 2013¿2022. THE STUDY INCLUDED 81 MEN AND 30 WOMEN (MEDIAN AGE 60 YEARS). OVERALL, 26 (23.4%) CASES PRESENTED WITH SUBARACHNOID HEMORRHAGE AND 85 (76.6%) PRESENTED WITH UNRUPTURED ANEURYSMS. PROCEDUREAL DETAILS: THE CONVENTIONAL STENTS INCLUDED NEUROFORM, ENTERPRISE, AND SOLITAIRE STENTS, AND A LOW-PROFILE VISUALIZED INTR ALUMINAL SUPPORT (LVIS) DEVICE WAS USED. THE FLOW DIVERTERS INCLUDED TUBRIDGE AND PIPELINE DEVICES. ALL EVT PROCEDURES WERE PERFORMED VIA A FEMORAL ARTERY APPROACH UNDER GENERAL ANESTHESIA. A STANDARD 6F OR 8F GUIDE CATHETER WAS ADVANCED INTO THE SUBCLAVIAN ARTERY , PROXIMAL TO THE VERTEBRAL ARTERY. AN INTERMEDIATE CATHETER (NAVIEN) WAS THEN INSERTED INTO THE V3 SEGMENT OF THE VERTEBRAL ARTERY. A STENT MICROCATHETER WAS USED TO ACCESS THE TRUE LUMEN OF THE ANEURYSM IN THE POSTERIOR CEREBRAL ARTERY THROUGH THE GUIDEWIRE. FOR CASES WITH ADDITIONAL COIL INSERTION, A COIL MICROCATHETER WAS PLACED IN THE ANEURYSM SAC. THE STENT WAS PARTIALLY DEPLOYED TO COVER THE ANEURYSM NECK AND TEMPORARILY JAIL THE MICROCATHETER, AFTER WHICH THE ANEURYSM WAS LOOSELY OR DENSELY PACKED WITH DETACHABLE COILS BEFORE THE STENT WAS COMPLETELY DEPLOYED. FOR LONG SEGMENTAL LESIONS IN WHICH THE ANEURYSM NECK COULD NOT BE COVERED COMPLETELY WITH A SINGLE STENT, AN ADDITIONAL STENT WAS EXTENDED INTO THE BRIDGED SEGMENT. IF A SINGLE STENT WAS NOT SUFFICIENT TO ALTER THE INTRA-ANEURYSMAL HEMODYNAMICS, OVERLAPPING STENTS WERE USED TO RECONSTRUCT THE LESION. RESULTS: SUCCESSFUL EVT WAS ACHIEVED IN ALL PATIENTS: TWO CASES UNDERWENT COILING WITHOUT STENTS, 85 CASES UNDERWENT STENT-ASSISTED COILING, AND 24 CASES UNDERWENT STENTING WITHOUT COILING. IN CASES WITH STENT IMPLANTATION, 70 RECEIVED A SINGLE STENT (INCLUDING 14 WHO RECEIVED A FLOW DIVERTER), 28 RECEIVED TWO CONVENTIONAL STENTS, AND 11 RECEIVED THREE CONVENTIONAL STENTS IN AN OVERLAPPING OR TELESCOPING FASHION. BALLOON ANGIOPLASTY WAS PERFORMED IN 13 CASES, INCLUDING 10 CASES WITH PARENT ARTERY STENOSIS AND TWO CASES OF INADEQUATE STENT EXPANSION. IMMEDIATE COMPLETE AND INCOMPLETE ANEURYSM OBLITERATION WAS ACHIEVED IN 58 AND 53 CASES, RESPECTIVELY. PROCEDURE-RELATED ISCHEMIC AND HEMORRHAGIC COMPLICATIONS OCCURRED IN 28/111 AND 3/111 CASES, RESPECTIVELY. OVERALL, 27 PATIENTS ONLY EXPERIENCED ISCHEMIC COMPLICATIONS IMMEDIATELY AFTER THE PROCEDURE. OF THESE, ONE PATIENT PRESENTED WITH INTRAOPERATIVE INTRALUMINAL THROMBUS. INTRAOPERATIVE THROMBOLYSIS, BALLOON ANGIOPLASTY, AND ADDITIONAL IMPLANTATION OF AN ENTERPRISE DEVICE WERE PERFORMED; A MILD NEUROLOGICAL DEFICIT WAS NOTICED AFTER THE PROCEDURE, BUT THE PATIENT RECOVERED COMPLETELY AFTER 3 MONTHS. THE PROCEDURE WAS SUCCESSFUL IN THE OTHER 26 CASES, LIKELY DUE TO THE OCCLUSION OF THE PERFORATOR VESSEL OR BRAINSTEM COMPRESSION DUE TO MASS EFFECT AFTER TREATMENT. ONE PATIENT WITH SACCULAR ANEURYSMS EXPERIENCED REBLEEDING DURING THE PROCEDURE; HOWEVER, THE ANEURYSM WAS COMPLETELY OBLITERATED UNDER THE TEMPORARY PROTECTION OF THE BALLOON. THIS PATIENT EXPERIENCED BRAINSTEM ISCHEMIA IMMEDIATELY AFTER TREATMENT BUT HAD NO NEUROLOGICAL DEFICIT AFTER 3 MONTHS. ONE PATIENT WITH SUBARCHNOID HEMORHHAGE (SAH) AND ONE PATIENT WITH DIZZINESS AT ADMISSION EXPERIENCED BRAINSTEM HEMORRHAGE WITHIN 12 HOURS AFTER TREATMENT AND DIED WITHIN 1 MONTH. OVERALL, PROCEDURE-RELATED ISCHEMIC  AND HEMORRHAGIC COMPLICATIONS OCCURRED IN 30/111 PATIENTS. IN THE 58 CASES WHO UNDERWENT THROMBOELASTOGRAPHY, NEITHER ADENOSINE DIPHOSPHATE NOR ARACHIDONIC ACID INHIBITION RATE WAS ASSOCIATED WITH PROCEDURAL THROMBOSIS OR HEMORRHAGIC COMPLICATIONS. ANEURYSM SIZE WAS THE ONLY PREDICTOR OF THESE COMPLICATIONS. ASYMPTOTIC BTAS TENDED TO BE ASSOCIATED WITH A LOWER RATE OF PROCEDURAL ISCHEMIC AND HEMORRHAGIC COMPLICATIONS. THE NON-PROCEDURAL COMPLICATIONS WERE AS FOLLOWS: ONE PATIENT EXPERIENCED REBLEEDING 1 WEEK AFTER EVT AND DIED; ANOTHER PATIENT WITH SAH EXPERIENCED DELAYED CEREBRAL INFARCTION AND DIED FROM PULMONARY INFECTION AND SEPTICEMIA; FIVE PATIENTS, INCLUDING ONE WITH A LARGE UNRUPTURED ANEURYSM AND FOUR PATIENTS WITH SAH, EXHIBITED SYMPTOMATIC HYDROCEPHALUS AND UNDERWENT EXTERNAL VENTRICULAR DRAINAGE OR VENTRICULO-PERITONEAL SHUNT PLACEMENT AFTER EMBOLIZATION. FOLLOW-UP: 12 PATIENTS EXPERIENCED NEW-ONSET COMPLICATIONS DURING FOLLOW-UP: TWO DEVELOPED EPILEPSY AND ONE DEVELOPED PROGRESSIVE NE UROLOGICAL DEFECTS. THE MAIN REASON FOR THESE COMPLICATIONS WAS MASS EFFECT ON THE BRAINSTEM, ALTHOUGH ANEURYSM REGROWTH OR RECANALIZATION CANNOT BE EXCLUDED. NEW-ONSET POSTERIOR CIRCULATION ISCHEMIA OCCURRED IN SEVEN CASES DUE TO EARLY WITHDRAWAL OF DUAL ANTIPLATELET THERAPY (TWO CASES) AND IN-STENT STENOSIS AFTER 10 MONTHS (ONE CASE). PARENCHYMAL HEMORRHAGE DURING DUAL ANTIPLATELET THERAPY O CCURRED IN ONE CASE. ONE PATIENT WITH A LARGER ANEURYSM EXPERIENCED SAH AND DIED AFTER 1 MONTH. THE OUTCOMES WERE FAVORABLE IN 92/111 CASES, AND THE OVERALL MORTALITY WAS 16/111. THE MAIN REASONS FOR MORTALITY WERE SERIOUS PROCEDURAL ISCHEMIC COMPLICATIONS (N=2), PROCEDURAL BRAIN HEMORRHAGIC COMPLICATIONS (N=2), ANEURYSM REBLEEDING (N=2), BRAINSTEM COMPRESSION (N=2), NEW ISCHEMIC DEFECTS (N=2), PARENCHYMAL HEMORRHAGE (N=1), INITIAL POOR HH GRADE (N=1), PULMONARY INFECTION (1 CASE WITH SAH), AND INFECTIOUS HYDROCEPHALUS (1 CASE WITH SAH). OLDER AGE, POOR HH GRADE, INCREASED ANEURYSM SIZE, AND HEMORRHAGIC COMPLICATIONS WERE INDEPENDENT RISK FACTORS FOR UNFAVORABLE CLINICAL OUTCOMES. ANGIOGRAPHIC FOLLOW-UP DATA FOR 3¿90 MONTHS WERE AVAILABLE FOR 77/95 SURVIVING PATIENTS. OVERALL, 55 ANEURYSMS EXHIBITED COMPLETE OCCLUSION AND 20 EXHIBITED INCOMPLETE OBLITERATION, INCLUDING 11 CASES WITH NECK REMNANTS AND NINE WITH RESIDUAL ANEURYSMS. ADDITIONAL TREATMENT WAS PERFORMED IN TWO CASES, RESULTING IN COMPLETE OCCLUSION AT FINAL FOLLOW-UP. THE ONLY PATIENT WITH A FUSIFORM ANEURYSM WAS TREATED WITH LVIS-ASSISTED COILING AND EXPERIENCED SYMPTOMATIC IN-STENT STENOSIS AFTER 10 MONTHS. INCREASED ANEURYSM SIZE AND INCOMPLETE ANEURYSM OCCLUSION ON IMMEDIATE ANGIOGRAPHY WERE INDEPENDENT RISK FACTORS FOR INCOMPLETE OCCLUSION DURING FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584322 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown Death