BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELLO BALLOON GUIDE CATHETER

    MDR report key: 20413770 · Received October 9, 2024

    Report

    Report Number
    2029214-2024-01820
    Event Type
    Death
    Date Received
    October 9, 2024
    Date of Event
    January 1, 2023
    Report Date
    October 9, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    SEE ADDITIONAL CODES FOR CORRECTED IMF CODE. 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

    L. CASTRO-AFONSO, V. FORNAZARI, J. MACHADO, G. NAKIRI, T. ABUD, L. MONSIGNORE, O. PONTES-NETO, AND D. ABUD; THE NEUROHOSPITALIST; 2023; 13(3) 243¿249; THROMBECTOMY FOR ANTERIOR CIRCULATION STROKE IN A WITNESSED LATE TIME WINDOW VERSUS EARLY TIME WINDOW; DOI: 10.11 77/19418744231159457. LITERATURE WAS REVIEWED REGARDING THE STUDY TITLED "THROMBECTOMY OUTCOMES IN THE LATE TIME WINDOW FOR PATIENTS WITH ANTERIOR LARGE VESSEL OCCLUSIONS." THE TIME FRAME OF THIS STUDY WAS JUNE 2011 AND JANUARY 2020. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: CELLO 8 OR 9F BALLOON GUIDE CATHETER (BGC) AND SOLITAIRE AB, SOLITAIRE FR, SOLITAIRE PLATINUM STENT RETRIEVERS. DEATHS OCCURRED IN THE STUDY POPULATION. THE MORTALITY RATES AT 3 MONTHS WERE 20.2% (66 PATIENTS) IN THE EARLY TIME WINDOW GROUP AND 25% (26 PATIENTS) IN THE LATE TIME WINDOW GROUP. THE SPECIFIC CAUSES OF DEATH WERE NOT SPECIFIED. AMONG PATIENT ADVERSE EVENTS INCLUDED: SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) OCCURRED IN 8.2% (27 PATIENTS) OF THE EARLY TIME WINDOW GROUP AND 5.7% (6 PATIENTS) OF THE LATE TIME WINDOW GROUP AT 3 MONTHS. 178 PATIENTS IN THE EARLY TIMES WINDOW DID NOT HAVE GOOD FUNCTIONAL OUTCOMES WITH MRS CORSES GREATER THAN 2 AND 63 PATIENTS IN THE LATE WINDOW DID NOT HAVE GOOD FUNCTIONAL OUTCOMES. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Description of Event or Problem · 0

    L. CASTRO-AFONSO, V. FORNAZARI, J. MACHADO, G. NAKIRI, T. ABUD, L. MONSIGNORE, O. PONTES-NETO, AND D. ABUD; THE NEUROHOSPITALIST; 2023; 13(3) 243¿249; THROMBECTOMY FOR ANTERIOR CIRCULATION STROKE IN A WITNESSED LATE TIME WINDOW VERSUS EARLY TIME WINDOW; DOI: 10.11 77/19418744231159457 LITERATURE WAS REVIEWED REGARDING THE STUDY TITLED "THROMBECTOMY OUTCOMES IN THE LATE TIME WINDOW FOR PATIENTS WITH ANTERIOR LARGE VESSEL OCCLUSIONS." THE TIME FRAME OF THIS STUDY WAS JUNE 2011 AND JANUARY 2020. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: CELLO 8 OR 9F BALLOON GUIDE CATHETER (BGC) AND SOLITAIRE AB, SOLITAIRE FR, SOLITAIRE PLATINUM STENT RETRIEVERS. DEATHS OCCURRED IN THE STUDY POPULATION. THE MORTALITY RATES AT 3 MONTHS WERE 20.2% (66 PATIENTS) IN THE EARLY TIME WINDOW GROUP AND 25% (26 PATIENTS) IN THE LATE TIME WINDOW GROUP. THE SPECIFIC CAUSES OF DEATH WERE NOT SPECIFIED. AMONG PATIENT ADVERSE EVENTS INCLUDED: SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) OCCURRED IN 8.2% (27 PATIENTS) OF THE EARLY TIME WINDOW GROUP AND 5.7% (6 PATIENTS) OF THE LATE TIME WINDOW GROUP AT 3 MONTHS. 178 PATIENTS IN THE EARLY TIMES WINDOW DID NOT HAVE GOOD FUCTIONAL OUTCOMES WITHS MRS CORSES GREATER THAN 2 AND 63 PATIENTS IN THE LATE WINDOW DID NOT HAVE GOOD FUCTIONAL OUTCOMES.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947044 CELLO BALLOON GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-CELLO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death