BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANT BALLOON

    MDR report key: 20744891 · Received November 21, 2024

    Report

    Report Number
    9612164-2024-05460
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    January 20, 2023
    Report Date
    November 21, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION REGARDING A JOURNAL ARTICLE ¿ ENDOVASCULAR REPAIR OF PENETRATING THORACIC AORTIC ULCERS USING TUBULAR STENT GRAFTS VERSUS STENT GRAFTS WITH A PROXIMAL SCALLOP¿.  KUPFERTHALER A, HAUCK SR, SCHWARZ M, KERN M, DEINSBERGER J, DACHS TM, NEUMAYER C, STELZMÜLLER ME, EHRLICH M, LOEWE C, FUNOVICS MA.  JOURNAL OF ENDOVASCULAR THERAPY. 2024 OCT;31(5):821-830.  DOI: 10.1177/15266028221149919. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING ¿ ENDOVASCULAR REPAIR OF PENETRATING THORACIC AORTIC ULCERS USING TUBULAR STENT GRAFTS VERSUS STENT GRAFTS WITH A PROXIMAL SCALLOP¿.  THE STUDY PERIOD WAS OVER A NINE-YEAR PERIOD. MULTIPLE MANUFACTURERS PRODUCTS ARE MENTIONED WITHIN THE ARTICLE. BALLOON ANGIOPLASTY USING RELIANT BALLOONS WERE USED IN CASES WHERE RESIDUAL PERFUSION OF THE AORTIC LESION WAS DETECTED OR WHERE IT WAS DEEMED NECESSARY BY THE INTERVENING PHYSICIAN DUE TO NECK ANATOMY.  THE FOLLOWING ADVERSE EVENTS OCCURRED IN THE PATIENT POPULATION: DISSECTION, STENOSIS, STROKE, PARAPARESIS , ISCHEMIA, RE-INTERVENTION INCLUDING STENT GRAFT IMPLANT PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MEDTRONIC STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS.  NO FURTHER INFORMATION WAS PROVIDED IN RELATION TO A MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2461032 RELIANT BALLOON CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND AB46

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention