BEUDAMED
    FDA Adverse Event Death Summary report: N

    TURBO-TANDEM LASER ATHERECTOMY CATHETER

    MDR report key: 24569590 · Received March 11, 2026

    Report

    Report Number
    3007284006-2026-00070
    Event Type
    Death
    Date Received
    March 11, 2026
    Date of Event
    April 24, 2024
    Report Date
    February 1, 2025
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    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/G4/H4) THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION IS UNKNOWN: MODEL/CATALOG NUMBER, DEVICE SERIAL NUMBER, UNIQUE ID, EXPIRATION DATE, 510K NUMBER, 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, DEATH IS LISTED AS A POTENTIAL ADVERSE EVENT WITH USE OF THE TURBO-TANDEM 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 DECEMBER 2015 TO NOVEMBER 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 #3007284006-2026-00071, 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, MDR #3016257349-2026-00007). 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 11 DEATHS THAT OCCURRED POST-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
    454079 TURBO-TANDEM LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| D GUIDEWIRE (MANUFACTURER, SIZE UNK)| INTRODUCER SHEATH (MANUFACTURER, SIZE UNK)| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM