BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 23520732 · Received November 11, 2025

    Report

    Report Number
    9612164-2025-05541
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    November 7, 2023
    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

    COMPARING PREDICTORS INFLUENCING RESTENOSIS FOLLOWING HIGH-DOSE DRUG-COATED BALLOON ANGIOPLASTY AND FLUOROPOLYMER-BASED DRUG-ELUTING STENTING IN FEMOROPOPLITEAL ARTERY LESIONS JOURNAL OF ENDOVASCULAR THERAPY 2025, VOL. 32(4) 1194¿1204 © THE AUTHOR(S) 2023 ARTICLE REUSE GUIDELINES: SAGEPUB.COM/JOURNALS-PERMISSIONS DOI: 10.1177/15266028231209234 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: DESPITE WIDESPREAD USE OF ANTI-RESTENOSIS DEVICES, DRUG-COATED BALLOONS (DCBS) AND DRUG-ELUTING STENTS (DESS), THEIR APPROPRIATE USE FOR FEMOROPOPLITEAL (FP) LESIONS HAS NOT BEEN WELL INVESTIGATED AND THE RISK FACTORS FOR RESTENOSIS HAVE NOT BEEN COMPARED. TO INVESTIGATE RISK FACTORS ASSOCIATED WITH RESTENOSIS AFTER ENDOVASCULAR THERAPY USING DCB AND DES FOR CONTEMPORARY FP LESIONS. MATERIALS AND METHODS: THIS SINGLE-CENTER, RETROSPECTIVE, OBSERVATIONAL STUDY EVALUATED 378 FP LESIONS IN 273 PATIENTS TREATED WITH DCB (278 LESIONS IN 193 PATIENTS) OR DES (120 LESIONS IN 106 PATIENTS). THE DCB USED WAS HIGH-DOSE DCB (IN.PACT, ADMIRAL. MEDTRONIC, INC.) AND DES WAS FLUOROPOLYMER-BASED DES (ELUVIA, BOSTON SCIENTIFIC). VESSEL PREPARATION FAILURE WAS DEFINED AS A RESIDUAL STENOSIS OF =50% AND A DISSECTION GRADE OF D OR GREATER ON PRE-DILATATION ANGIOGRAPHY. THE OUTCOME MEASURE WAS RESTENOSIS, AND FACTORS ASSOCIATED WITH RESTENOSIS IN THE DCB AND DES GROUPS WERE ASSESSED USING A COX PROPORTIONAL HAZARDS MODEL. RESULTS: THE 2-YEAR RESTENOSIS RATE WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN THE DCB AND DES GROUPS (29%±4% VS. 24%±5%, P=0.42). INTERACTION ANALYSIS DEMONSTRATED THAT POPLITEAL LESIONS AND PLAQUE BURDEN OF =50% WERE RESTENOSIS-RELATED FACTORS FOR DES BUT NOT FOR DCB, WHEREAS VESSEL PREPARATION FAILURE WAS A FACTOR FOR DCB BUT NOT FOR DES (P 0.05). VESSEL DIAMETER OF 6 MM AND NODULAR CALCIFICATION WERE RISK FACTORS IN BOTH GROUPS (P 0.05). CONCLUSION: IN CONTEMPORARY FP LESIONS, SMALLER VESSELS AND NODULAR CALCIFICATION WERE SHARED RESTENOSIS-RELATED FACTORS FOR HIGH-DOSE DCB AND FLUOROPOLYMER-BASED DES. POPLITEAL LESIONS AND PLAQUE BURDEN OF =50% WERE RESTENOSISRELATED FACTORS FOR FLUOROPOLYMER-BASED DES AND VESSEL PREPARATION FAILURE FOR HIGH-DOSE DCB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2581854 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS ONU MEDTRONIC IRELAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention