BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPIDER FX

    MDR report key: 20479240 · Received October 18, 2024

    Report

    Report Number
    2183870-2024-00364
    Event Type
    Death
    Date Received
    October 18, 2024
    Date of Event
    June 10, 2024
    Report Date
    October 18, 2024
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    PMA / PMN Number
    K063204
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    LITERATURE REFERENCE:DOI: 10.1161/CIRCINTERVENTIONS.124.01404. 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

    LITERATURE WAS REVIEWED REGARDING: THE CLINICAL OUTCOMES OF PERCUTANEOUS TRANSCATHETER RELEASE OF STUCK MECHANICAL MITRAL VALVE WITH PETROS PERCUTANEOUS TRANSCATHETER RELEASE OF STUCK MECHANICAL VALVE (PETROS) WITH CEREBRAL EMBOLIC PROTECTION (CEP). THE TIME FRAME OF THIS STUDY WAS: FROM 2020 TO 2023 MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION, WHICH INCLUDED MEDTRONIC SPIDERFX EMBOLIC PROTECTION DEVICE USED IN EACH ICA THROUGH THE RIGHT AND LEFT COMMON FEMORAL ARTERIES. THE CEP WAS ONLY PARTIAL AS THE VERTEBRAL ARTERIES WERE NOT PROTECTED. AN INTERVENTIONAL RADIOLOGIST WAS ON CALL TO INTERVENE IN CASE OF VERTEBRAL ARTERY EMBOLISM BUT WAS NEVER REQUIRED. THE FILTERS SHOWED DEBRIS IN THE RIGHT INTERNAL CAROTID ARTERY (2.50%; N=3), LEFT INTERNAL CAROTID ARTERY (4.20%; N=1), AND BOTH FILTERS (4.20%; N=1). NO DEBRIS WAS FOUND IN 79.20% (N=19) OF CASES. THREE DEATHS WERE REPORTED IN THE POPULATION. ONE PATIENT DIED DUE TO SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH TYPE-II RESPIRATORY FAILURE, DESPITE A TECHNICAL SUCCESS, AND A 2ND PATIENT HAD A SUDDEN DEATH ON THE 64TH DAY OF POST-PETROS. FOR THE THIRD PATIENT, DURING THE ATTEMPT TO REMOVE THE GUIDE CATHETER, THE THROMBUS ACCIDENTALLY EMBOLIZED AND CLOGGED THE FILTER, AND THERE WAS NO FLOW BEYOND THE FILTER. WHILE REMOVING THE FILTER, THE THROMBUS SPILLED OUT, AND BOTH THE LEFT MIDDLE CEREBRAL ARTERY AND ANTERIOR CEREBRAL ARTERY WERE OCCLUDED. IMMEDIATE ASPIRATION WAS DONE BUT WAS ONLY PARTIALLY SUCCESSFUL WITH SLOW FILLING OF THE DISTAL VESSELS. INTRA-ARTERIAL RETEPLASE BOLUS OF 5 UNITS WAS GIVEN, AND THE PATIENT WAS SHIFTED TO CARDIAC INTENSIVE CARE AFTER ENDOTRACHEAL INTUBATION AND MECHANICAL VENTILATION. MITRAL PETROS WAS DEFERRED. THE PATIENT DEVELOPED DENSE HEMIPLEGIA WITH APHASIA. SERIAL CT BRAIN SHOWED MASSIVE LEFT MIDDLE CEREBRAL ARTERY AND ANTERIOR CEREBRAL ARTERY TERRITORY INFARCT WITH MIDLINE SHIFT. THE PATIENT DIED ON THE SEVENTH DAY AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231571 SPIDER FX TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death