BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT 018 PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (ONU) BALLOO

    MDR report key: 21169053 · Received January 16, 2025

    Report

    Report Number
    9612164-2025-00301
    Event Type
    Injury
    Date Received
    January 16, 2025
    Date of Event
    December 16, 2024
    Report Date
    January 16, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Description of Event or Problem · 0

    DURING THE INDEX PROCEDURE TWO IN.PACT 018 BALLOONS WERE USED TO TREAT THE RIGHT SUPERFICIAL ARTERY. POST PROCEDURE PATIENT SUFFERED DISSECTION GRADE D AFTER DRUG-COATED BALLOON TREATMENT RIGHT SUPERFICIAL ARTERY MID. THE EVENT WAS TREATED WITH A STENT DURING THE INDEX PROCEDURE. PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509401 IN.PACT 018 PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (ONU) BALLOO DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS ONU MEDTRONIC IRELAND 0012425498

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention