BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 23486817 · Received November 6, 2025

    Report

    Report Number
    9612164-2025-05464
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    January 22, 2025
    Report Date
    November 6, 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

    LITERATURE TITLE INTRAVASCULAR ULTRASOUND-GUIDED VS ANGIOGRAPHY-GUIDED DRUG-COATED BALLOON ANGIOPLASTY IN PATIENTS WITH COMPLEX FEMOROPOPLITEAL ARTERY DISEASE JACC: CARDIOVASCULAR INTERVENTIONS VOL. 18, NO. 5, 2025 ª 2025 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER ISSN 1936-8798/$36.00 HTTPS://DOI.ORG/10.1016/J.JCIN.2024.10.052 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

    BACKGROUND INTRAVASCULAR ULTRASOUND (IVUS) GUIDANCE HAS BEEN SHOWN TO YIELD FAVORABLE OUTCOMES FOR ENDOVASCULAR TREATMENT OF FEMOROPOPLITEAL ARTERY (FPA) DISEASE WITH DRUG-COATED BALLOON (DCB) ANGIOPLASTY. HOWEVER, THE SPECIFIC BENEFITS OF IVUS FOR TREATMENT OF COMPLEX FPA LESIONS REMAIN UNCERTAIN. OBJECTIVES IN THIS STUDY, THE AUTHORS COMPARED THE CLINICAL IMPACT OF IVUS-GUIDED VS ANGIOGRAPHY-GUIDED DCB ANGIOPLASTY IN PATIENTS WITH COMPLEX OR NONCOMPLEX FPA LESIONS. METHODS THIS STUDY WAS A PRESPECIFIED, PRIMARY SUBGROUP ANALYSIS OF THE RANDOMIZED IVUS-DCB TRIAL. PATIENTS WITH FPA UNDERGOING DCB ANGIOPLASTY WERE RANDOMIZED TO RECEIVE THE PROCEDURE UNDER IVUS OR ANGIOGRAPHY GUIDANCE. THE PRIMARY ENDPOINT WAS 12-MONTH PRIMARY PATENCY; SECONDARY ENDPOINTS INCLUDED CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (CD-TLR), SUSTAINED CLINICAL IMPROVEMENT, AND HEMODYNAMIC IMPROVEMENT. RESULTS AMONG THE 237 PATIENTS ENROLLED, 158 HAD COMPLEX FPA (TRANS-ATLANTIC INTER-SOCIETY CONSENSUS II [TASC II] TYPE C/D), AND 79 HAD NONCOMPLEX FPA (TASC II TYPE A/B). IN COMPLEX FPA, IVUS GUIDANCE WAS ASSOCIATED WITH SIGNIFICANTLY HIGHER RATES OF PRIMARY PATENCY (82.1% VS 60.3%; HR FOR LOSS OF PRIMARY PATENCY: 0.34; 95% CI: 0.16-0.70; P ¼ 0.002), FREEDOM FROM CD-TLR (90.0% VS 76.9%; HR: 0.31; 95% CI: 0.13-0.75; P ¼ 0.01), AND SUSTAINED CLINICAL AND HEMODYNAMIC IMPROVEMENT RELATIVE TO ANGIOGRAPHY GUIDANCE. THERE WAS NO SIGNIFICANT DIFFERENCE IN PRIMARY PATENCY (87.5% VS 88.2%; HR: 1.84; 95% CI: 0.39-8.60; P ¼ 0.44) OR OCCURRENCE SECONDARY ENDPOINTS BETWEEN THE IVUS-GUIDANCE AND ANGIOGRAPHY-GUIDANCE GROUPS FOR PATIENTS WITH NONCOMPLEX FPA. CONCLUSIONS IN ENDOVASCULAR TREATMENT OF FPA USING DCB, IVUS GUIDANCE WAS SIGNIFICANTLY ASSOCIATED WITH IMPROVED 12-MONTH CLINICAL OUTCOMES, PARTICULARLY IN PATIENTS WITH COMPLEX FPA LESIONS. (INTRAVASCULAR ULTRASOUND-GUIDED DRUG- COATED BALLOON ANGIOPLASTY FOR FEMOROPOPLITEAL ARTERY DISEASE [IVUS-DCB] TRIAL; NCT03517904) (JACC CARDIOVASC INTERV. 2025;18:558¿569) © 2025 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2637861 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS ONU MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention