BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANT BALLOON

    MDR report key: 20851791 · Received December 5, 2024

    Report

    Report Number
    9612164-2024-05793
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    August 22, 2023
    Report Date
    December 5, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿INTRA-SAC INJECTION OF THROMBIN DURING ENDOVASCULAR ANEURYSM REPAIR TO REMEDY TYPE II ENDOLEAK AND PROMOTE SAC SHRINKAGE¿. ZHAO SL, XIONG JP, LUAN JY, ET AL. VASCULAR AND ENDOVASCULAR SURGERY. 2024;58(2):151-157. DOI:10.1177/15385744231197457. 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 ¿INTRA-SAC INJECTION OF THROMBIN DURING ENDOVASCULAR ANEURYSM REPAIR TO REMEDY TYPE II ENDOLEAK AND PROMOTE SAC SHRINKAGE¿. THE TIME FRAME OF THIS STUDY WAS OVER A FOUR-YEAR PERIOD. MULTIPLE MANUFACTURES PRODUCTS WERE IMPLANTED. ENDURANT STENT GRAFTS WERE IMPLANTED IN THE PATIENT POPULATION. RELIANT BALLOONS WERE USED INTRAOPERATIVELY IF A TYPE II ENDOLEAK WAS DETECTED OR IF THE PATIENT HAD A RUPTURED ANEURYSM. THE AIM OF THE STUDY WAS TO EVALUATE THE SAFETY AND EFFECTIVENESS OF INTRA-SAC THROMBIN INJECTION TO REMEDY TYPE II ENDOLEAKS (T2ELS) DURING ENDOVASCULAR ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS OCCURRED: HEMATOMA, FEVER, MULTIPLE ORGAN FAILURE, STROKE, CARDIAC ARREST, THROMBOSIS, INTERVENTION PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT PRODUCT CAUSED OR CONTRIBUTED TO ANY DEATHS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977376 RELIANT BALLOON CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND AB46

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| O