BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT AV ACCESS

    MDR report key: 22870483 · Received August 22, 2025

    Report

    Report Number
    9612164-2025-04136
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    June 29, 2023
    Report Date
    August 22, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PRC
    UDI-DI
    00763000232658
    PMA / PMN Number
    P190008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 4 IN.PACT AV ACCESS BALLOON CATHETERS WERE USED TO TREAT THE VENOUS OUTFLOW, BRACHIOCEPHALIC/SUPERIOR VENA CAVA (SVC) STENT AND THE CEPHALIC ARCH OF THE RIGHT ARM. APPROXIMATELY 8 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM VENOUS OUTFLOW RESTENOSIS OF THE AVF. THE RESTENOSIS IN THE INDEX LESION WAS SUCCESSFULLY TREATED WITH A TARGET LESION REVASCULARIZATION USING A PLAIN BALLOON ANGIOPLASTY WITH 0% RESIDUAL STENOSIS. THE SVC STENT, CENTRAL VEIN AND VENOUS OUTFLOW WERE TREATED DURING THE REVA SCULARIZATION. THE PATIENT WAS ALSO TREATED WITH MEDICATION. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193117 IN.PACT AV ACCESS DRUG-COATED PERIPHERAL TRANSLUMINAL ANGIOPLAST PRC MEDTRONIC IRELAND 0011236924 00763000232658

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other| R