BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANT BALLOON

    MDR report key: 12428420 · Received September 6, 2021

    Report

    Report Number
    9612164-2021-03434
    Event Type
    Injury
    Date Received
    September 6, 2021
    Date of Event
    November 3, 2016
    Report Date
    September 6, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; RESULTS FROM A NATIONWIDE REGISTRY ON SCALLOPED THORACIC STENT-GRAFTS FOR SHORT LANDING ZONES VAN DER WEIJDE E, BAKKER OJ, TIELLIU IFJ, ZEEBREGTS CJ, HEIJMEN RH. RESULTS FROM A NATIONWIDE REGISTRY ON SCALLOPED THORACIC STENT-GRAFTS FOR SHORT LANDING ZONES. JOURNAL OF ENDOVASCULAR THERAPY. 2017;24(1):97-106. DOI:10.1177/1526602816674942. AGE OR DATE OF BIRTH: MEAN AGE. SEX: MEAN GENDER. EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    RELIANT STENT GRAFT BALLOONS WAS USED IN CONJUNCTION WITH NON MDT STENT GRAFTS DURING THE TEVAR ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: ACCESS SITE¿RELATED COMPLICATIONS - RETROPERITONEAL HEMATOMA (TREATED CONSERVATIVELY), SEROMA (DRAINED), COMMON FEMORAL ARTERY (CFA) PSEUDOANEURYSM ON THE SIDE WITH THE ANGIOCATHETER (TREATED WITH ULTRASOUND-GUIDED THROMBIN INJECTION), AND MINOR BLEEDING FROM BOTH GROINS (TREATED WITH PRESSURE BANDAGES). ONE PATIENT WITH A DISTAL SCALLOP HAD A CFA DISSECTION (TREATED WITH PATCH-PLASTY). THE CAUSE OF THE EVENTS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENTS WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327511 RELIANT BALLOON CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND AB46

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention