BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACT CATHETER

    MDR report key: 19079276 · Received April 10, 2024

    Report

    Report Number
    2029214-2024-00621
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    November 20, 2023
    Report Date
    May 22, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    PMA / PMN Number
    K182097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    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

    LEKCHAROENSOMBAT, N., CHANTHANAPHAK E., BOONGIRD, A. URGENT MECHANICAL THROMBECTOMY UNLOCKED THE DEVASTATING ACUTE SUPERIOR SAGITTAL SINUS THROMBOSIS COMPLICATED WITH ACUTE STATUS EPILEPTICUS: CASE REPORT. INTERDISCIPLINARY NEUROSURGERY: ADVANCED TECHNIQUES AND CASE MANAGEMENT. 2024. 101926. DOI: 10.1016/J.INAT.2023.101926 SUMMARY: THE MAINSTAY TREATMENT OF UNCOMPLICATED CEREBRAL VENOUS SINUS THROMBOSIS (CVST) IS AN ANTICOAGULANT MEDICATION AND GETS RID OF THE CAUSE OF THE DISEASE AS SOON AS POSSIBLE. ENDOVASCULAR TREATMENT IS RECOMMENDED IN COMPLICATED CASES WITHOUT DEFINITE STANDARD GUIDELINES FOR TIMING OF INTERVENTION. IN CONTRAST TO, THE GUIDELINE AND TIMING OF INTERVENTION FOR ACUTE CONVULSIVE STATUS EPILEPTICUS. WITH PREDICTABLE OF THE CRITICALLY COMPLICATED CVST WITH ACUTE STATUS EPILEPTICUS AND BIFRONTAL HEMORRHAGES, URGENT THROMBECTOMY WITHIN 48 H AFTER MEDICAL FAILURE IS ABLE TO RESTORATION OF VENOUS FLOW IN TIME FOR RESCUE THE EDEMATOUS BRAIN, STOP FURTHER VENOUS BLEEDING, EASE SEIZURE CONTROLLED AND FINALLY LEAD TO RAPIDLY RECOVERY OF THE DEVASTATING CONDITIONS WITH AN EXCELLENT OUTCOME. REPORTED EVENTS: A 48-YEAR-OLD THAI FEMALE PRESENTED WITH A HISTORY OF CHRONIC PROGRESSIVE HEADACHE FOR 2 WEEKS. SEVEN HOURS PRIOR TO VISITING THE PR IMARY CARE HOSPITAL, SHE COMPLAINED THAT SHE EXPERIENCED A SUDDEN LEFT SIDE LIMB WEAKNESS. MECHANICAL THROMBECTOMY WAS PERFORMED USING REACT TM 71 (MEDTRONIC, IRVINE, USA) WITH MULTIPLE ATTEMPTS OF MANUAL ASPIRATION USING 60-ML VACLOK SYRINGE (MERIT MEDICAL SYSTEM, SOUTH JORDAN, USA) (FIG. 2C, D). RECANALIZED TIME 130 MIN AFTER ARRIVAL AT THE ANGIOGRAM ROOM (47 H AFTER DIAGNOSIS), AN ABUNDANCE OF CLOT WAS RETRIEVED (FIG. 2E). POST ASPIRATION ANGIOGRAM REVEALED PARTIAL RECANALIZED ANTERIOR TO MIDDLE SSS WITH IMPROVEMENT OF BILATERAL CORTICAL VENOUS DRAINAGE. LATER ON, HER RAPID RECOVERY WAS OBSERVED IN ONE WEEK WITH SOME SWALLOWING PROBLEM AND LEFT HEMIPARESIS. AFTER ONE MONTH IN AN INTENSIVE REHABILITATION UNIT, SHE CAN EAT BY HERSELF, WALK WITH GAIT AID BUT LEFT HAND HAS NOT FULLY RECOVERED. (MRS2) CT VENOGRAPHY BRAIN SHOWN NEARLY COMPLETE RECANALIZATION OF SSS (FIG. 2F). AT 2 MONTHS AT OUTPATIENT CLINIC FOLLOW-UP, SHE HAS NORMAL BOTH VISIONS AND CAN WALK INDEPENDENTLY, HER LEFT HAND WAS SIGNIFICANTLY IMPROVED (MRS1). NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTHCARE PROVIDER (HCP) THINKS THE MEDTRONIC DEVICE IS HELPING THE PATIENT AND DID NOT COMPLICATE THE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407049 REACT CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 REACT-71 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other