BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 23520572 · Received November 11, 2025

    Report

    Report Number
    9612164-2025-05538
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    May 22, 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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE-YEAR CLINICAL OUTCOMES AND PREDICTORS OF DISTAL EMBOLIZATION AFTER JETSTREAMTM ATHERECTOMY FOR CALCIFIED FEMOROPOPLITEAL ARTERY LESIONS: RESULTS FROM THE JETFORWARD STUDY CARDIOVASC INTERVENT RADIOL (2025) 48:760¿768 HTTPS://DOI.ORG/10.1007/S00270-025-04063-1 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

    ABSTRACT PURPOSE THIS STUDY AIMED TO IDENTIFY PREDICTORS OF DISTAL EMBOLIZATION FOLLOWING JETSTREAMTM ATHERECTOMY FOR CALCIFIED FEMOROPOPLITEAL LESIONS AND EVALUATE 1-YEAR CLINICAL OUTCOMES IN A REAL-WORLD SETTING. MATERIALS AND METHODS WE ANALYZED DATA FROM 109 PATIENTS WITH 121 CALCIFIED FEMOROPOPLITEAL LESIONS WHO UNDERWENT JETSTREAMTM ATHERECTOMY THERAPY BETWEEN OCTOBER 2022 AND DECEMBER 2023 AS PART OF THE JETFORWARD STUDY, A RETROSPECTIVE, SINGLE-ARM, MULTICENTER STUDY. DISTAL EMBOLIZATION INCIDENCE AND RISK FACTORS WERE THE PRIMARY FOCUS, WHILE 1-YEAR PRIMARY PATENCY SERVED AS EFFICACY OUTCOME MEASURES. SAFETY OUTCOMES ALSO INCLUDED MORTALITY AND MAJOR TARGET LIMB AMPUTATION. RESULTS THE MEAN LESION LENGTH WAS 15.5 ± 9.4 CM, AND THE TECHNICAL SUCCESS RATE¿DEFINED AS RESIDUAL STENOSIS LESS THAN 30% AND ABSENCE OF GRADE C OR HIGHER DISSECTION POSTPROCEDURE¿ WAS 93.4%. ANGIOGRAPHICALLY SIGNIFICANT DISTAL EMBOLIZATION OCCURRED IN 35.5% OF CASES DURING THE INDEX PROCEDURE. ON MULTIVARIATE ANALYSIS, POOR TIBIAL RUNOFF (B 1 TIBIAL ARTERY), SEVERE SMALL ARTERY DISEASE, NODULAR CALCIFICATION, AND DEBULKING LENGTHS [10 CM WERE INDEPENDENT PREDICTORS OFDISTAL EMBOLIZATION. THE 1-MONTH MORTALITY AND 1-YEAR LIMB SALVAGE RATES WERE 2.8% AND 98.9%, RESPECTIVELY. THE 1-YEAR PRIMARY PATENCY RATE WAS 88.9%. CONCLUSION ANGIOGRAPHICALLY SIGNIFICANT DISTAL EMBOLIZATION OCCURRED IN 35.5% OF CASES WITH JETSTREAM ATHERECTOMY, WHILE 1-YEAR OUTCOMES REMAINED FAVORABLE IN TREATING FEMOROPOPLITEAL LESIONS. THIS STUDY ALSO IDENTIFIED FOUR PREDICTORS OF DISTAL EMBOLIZATION. THUS, CAREFUL RISK FACTOR EVALUATION AND PATIENT SELECTION ARE ESSENTIAL DURING ATHERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580894 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS ONU MEDTRONIC IRELAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention