BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 23521217 · Received November 11, 2025

    Report

    Report Number
    9612164-2025-05548
    Event Type
    Death
    Date Received
    November 11, 2025
    Date of Event
    February 17, 2025
    Report Date
    November 11, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPARISON OF HIGH-DOSE VERSUS LOW-DOSE PACLITAXEL DRUG-COATED BALLOONS FOR NATIVE FEMOROPOPLITEAL ARTERY DISEASE: AN ANALYSIS OF THE K-VIS ELLA REGISTRY YONSEI MED J 2025 JUL;66(7):412-420 HTTPS://DOI.ORG/10.3349/YMJ.2024.0166 A2 AVERAGE AGE A3 MAJORITY GENDER B3 DATE OF PUBLICATION 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

    PURPOSE: DRUG-COATED BALLOONS (DCBS) HAVE DEMONSTRATED FAVORABLE OUTCOMES IN THE TREATMENT OF FEMOROPOPLITEAL ARTERY (FPA) DISEASE. A VARIETY OF DCBS ARE CURRENTLY AVAILABLE, WITH DIFFERING DOSES OF ANTIPROLIFERATIVE AGENTS AND TYPES OF EXCIPIENTS. THE OBJECTIVE OF THIS STUDY WAS TO COMPARE THE EFFICACY AND SAFETY OF HIGH-DOSE VERSUS LOW-DOSE PACLITAXEL DCBS FOR THE TREATMENT OF FPA DISEASE. MATERIALS AND METHODS: WE ANALYZED DATA FROM THE MULTICENTER THE KOREAN VASCULAR INTERVENTION SOCIETY ENDOVASCULAR THERAPY IN LOWER LIMB ARTERY DISEASES (K-VIS ELLA) REGISTRY, FOCUSING ON PATIENTS TREATED WITH A HIGH-DOSE PACLITAXEL DCB (IN. PACTTM) OR LOWDOSE PACLITAXEL DCB (LUTONIXTM OR RANGERTM) FOR NATIVE VESSEL FPA DISEASE. WE USED INVERSE PROBABILITY OF TREATMENT WEIGHTING TO ADJUST FOR CONFOUNDING FACTORS AND CONDUCTED SUBGROUP ANALYSES BASED ON LESION CHARACTERISTICS. RESULTS: AMONG 820 TARGET LIMBS, 626 WERE TREATED WITH A HIGH-DOSE PACLITAXEL DCB, AND 194 WERE TREATED WITH A LOW-DOSE PACLITAXEL DCB. AT 12 MONTHS, THERE WERE NO SIGNIFICANT DIFFERENCES IN RATES OF FREEDOM FROM CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (TLR; 91.7% VS. 89.4%, LOG-RANK P=0.35), MAJOR ADVERSE LIMB EVENT (MALE; 91.4% VS. 89.0%, LOG-RANK P=0.31), OR ALL-CAUSE MORTALITY (93.1% VS. 93.8%, LOG-RANK P=0.79) BETWEEN HIGH-DOSE AND LOW-DOSE GROUPS. ON MULTIVARIABLE ANALYSIS, THE PRESENCE OF CHRONIC HEART FAILURE AND CHRONIC KIDNEY DISEASE WERE THE ONLY INDEPENDENT PREDICTORS OF CLINICALLY DRIVEN TLR AFTER DCB TREATMENT. CONCLUSION: IN THIS MULTICENTER COHORT STUDY OF PATIENTS WITH COMPLEX FPA DISEASE, THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN HIGH-DOSE DCB AND LOW-DOSE DCB WITH RESPECT TO FREEDOM FROM CLINICALLY DRIVEN TLR, MALE, OR ALL-CAUSE MORTALITY AT 12-MONTH FOLLOW-UP. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580962 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS ONU MEDTRONIC IRELAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death| R