BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAREX 0.035" OTW DRUG-COATED ANGIOPLASTY BALLOON

    MDR report key: 24569593 · Received March 11, 2026

    Report

    Report Number
    3016257349-2026-00007
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    April 24, 2024
    Report Date
    February 1, 2025
    Manufacturer
    PHILIPS IMAGE GUIDED THERAPY CORPORATION
    Product Code
    ONU
    PMA / PMN Number
    P160049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2-A6) PATIENT INFORMATION - GENERALIZED PATIENT INFORMATION WAS LISTED; HOWEVER, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED. B4) DATE LISTED IS THE DATE THE MANUFACTURER BECAME AWARE. B6/B7) PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY - GENERALIZED PATIENT INFORMATION WAS LISTED; HOWEVER, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED. D4/H4) THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION IS UNKNOWN: MODEL/CATALOG NUMBER, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. E) ALTHOUGH THE JOURNAL ARTICLE ORIGINATED FROM FRANCE, PHYSICIAN AND FACILITY INFORMATION ARE UNKNOWN; THEREFORE, THE INFORMATION LISTED IS THE CORRESPONDING AUTHOR OF THE JOURNAL ARTICLE. G3) THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW FOR LITERATURE MDR PER CAPA 207. H3) THE DEVICE WAS DISCARDED, THUS NO PRODUCT INVESTIGATION WAS PERFORMED. H6) PER IFU, AMPUTATION AND OCCLUSION ARE LISTED AS POTENTIAL ADVERSE EVENTS WITH USE OF THE STELLAREX DEVICE. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    A PHILIPS EMPLOYEE BECAME AWARE OF A JOURNAL ARTICLE (PUBLISHED ONLINE 24APR2024) ¿DUCASE E ET AL_2024_OUTCOMES AND COMPARATIVE ANALYSIS OF THE INITIAL RESULT OF STANDARD BALLOON ANGIOPLASTY VERSUS DRUG-COATED BALLONS ALONE VERSUS IN ASSOCIATION WITH LASER-EXCIMER ATHERECTOMY IN THE TREATMENT OF FEMOROPOPLITEAL ARTERY IN-STENT RESTENOSIS (INTACT)¿. THE ARTICLE RETROSPECTIVELY REVIEWED A STUDY/RANDOMIZED CONTROLLED TRIAL AIMED TO COMPARE DRUG-COATED BALLOONS (DCBS) USED ALONE OR IN ASSOCIATION WITH EXCIMER LASER ATHERECTOMY (ELA) TO SIMPLE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF FEMOROPOPLITEAL- IN-STENT RESTENOSIS (ISR). A TOTAL OF 134 PATIENTS ACROSS 14 FRENCH CENTER FROM (B)(6) 2015 TO (B)(6) 2019 WERE ENROLLED IN THE STUDY. ALL LESIONS WERE SEQUENTIALLY TREATED WITH SPECTRANETICS TURBO-ELITE AND TURBO-TANDEM LASER ATHERECTOMY CATHETERS, BD BARD LUTONIX, MEDTRONIC INPACT, AND PHILIPS STELLAREX DRUG-COATED BALLOONS (DCBS), OR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). PATIENTS UNDERWENT CLINICAL FOLLOW-UP AT DISCHARGE AND CLINICAL FOLLOW-UP WITH DUPLEX ULTRASOUND (DUS) AT 1, 6, 12, AND 18 MONTHS. DEATHS OCCURRED IN 11 PATIENTS (DUE TO SEPTIC SHOCK, PNEUMONIA, CANCER, SLIP SYNDROME, MYOCARDIAL INFARCTION, PNEUMONIA, OR STROKE (MDR #3007284006-2026-00070, MDR #3007284006-2026-00071, MDR #3016257349-2026-00006). ADDITIONALLY POST-PROCEDURE COMPLICATIONS INCLUDED 6 AMPUTATIONS (65-YEAR-OLD (MDR #3007284006-2026-00068) AND 76-YEAR-OLD MALE (MDR #3007284006-2026-00069) DUE TO RESTENOSIS AFTER USE OF THE TURBO-ELITE), 31 OCCLUSIONS, 25 PATIENTS REQUIRED ADDITIONAL STENTING, AND 8 REQUIRED BYPASS PROCEDURE (MDR #3007284006-2026-00072, MDR #3007284006-2026-00073). ALTHOUGH GENERALIZED PATIENT INFORMATION/MEDICAL HISTORY WAS LISTED WITHIN THE JOURNAL ARTICLE, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED FOR MOST OF THE ADVERSE EVENTS INVOLVING THE SPECTRANETICS DEVICES. ADDITIONALLY, THE DATE OF PROCEDURE WAS NOT LISTED FOR THESE EVENTS; THEREFORE, 24APR2024 HAS BEEN USED, THE DATE OF PUBLICATION. ARTICLE CITATION: DUCASE E ET AL_2024_OUTCOMES AND COMPARATIVE ANALYSIS OF THE INITIAL RESULT OF STANDARD BALLOON ANGIOPLASTY VERSUS DRUG-COATED BALLONS ALONE VERSUS IN ASSOCIATION WITH LASER-EXCIMER ATHERECTOMY IN THE TREATMENT OF FEMOROPOPLITEAL ARTERY IN-STENT RESTENOSIS (INTACT). JOURNAL OF ENDOVASCULAR THERAPY 1¿15. J ENDOVASC THER 2026 FEB;33(1):244-258. EPUB 2024 APR 24. ARTICLE LINK: DOI: 10.1177/15266028241248333HTTPS://DOI.ORG/10.1177/1526602824124833 THIS REPORT CAPTURES THE 6 AMPUTATIONS, 31 OCCLUSIONS, 25 PATIENTS THAT REQUIRED ADDITIONAL STENTING, AND 8 THAT REQUIRED BYPASS PROCEDURE. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS/PHILIPS DEVICES IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627637 STELLAREX 0.035" OTW DRUG-COATED ANGIOPLASTY BALLOON DCB PTA CATHETER ONU PHILIPS IMAGE GUIDED THERAPY CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GUIDEWIRE (MANUFACTURER, SIZE UNK)| INTRODUCER SHEATH (MANUFACTURER, SIZE UNK)