BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELCA CORONARY LASER ATHERECTOMY CATHETER

    MDR report key: 25106623 · Received May 6, 2026

    Report

    Report Number
    3007284006-2026-00195
    Event Type
    Death
    Date Received
    May 6, 2026
    Date of Event
    May 13, 2024
    Report Date
    October 1, 2025
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    LPC
    PMA / PMN Number
    P910001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE - MEAN AGE 64.5 ± 10.6. A3A) PATIENT SEX - 47 MALES, 8 FEMALES. A4) PATIENT WEIGHT - 25.6 (BMI). A3B/A5/A6) SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED. B4) DATE LISTED IS THE DATE THE MANUFACTURER BECAME AWARE. B6) PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY - SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED. D4/H4) THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION IS UNKNOWN: MODEL/CATALOG NUMBER, DEVICE SERIAL NUMBER, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. E) ALTHOUGH THE JOURNAL ARTICLE ORIGINATED FROM CHINA, 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 ELCA DEVICES. 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 13MAY2024) ¿DEBULKING WITH EXCIMER LASER CORONARY ANGIOPLASTY VERSUS BALLOON ANGIOPLASTY IN PATIENTS WITH IN STENT RESTENOSIS (ELDISR STUDY): A RANDOMIZED CONTROLLED TRIAL¿. THE STUDY RETROSPECTIVELY AIMED TO EVALUATE THE EFFECT OF ELCA-BASED LESION PREPARATION ON THE CLINICAL OUTCOMES OF IN-STENT RESTENOSIS (ISR) PATIENTS TREATED WITH STANDARD DRUG-COATED BALLOON (DCB) ANGIOPLASTY. A TOTAL OF 110 PATIENTS WITH ISR WERE ENROLLED IN THE STUDY BETWEEN OCTOBER 2021 AND JUNE2023. ALL LESIONS WERE SEQUENTIALLY TREATED WITH SPECTRANETICS ELCA LASER ATHERECTOMY CATHETERS. PROCEDURAL COMPLICATIONS INCLUDED 1 TYPE C OR ABOVE DISSECTION AND 4 NO-REFLOW. DURING THE 1-YEAR FOLLOW-UP, 2 PATIENTS EXPERIENCED MYOCARDIAL INFARCTION AND 5 REQUIRED REPEAT TARGET LESION REVASCULARIZATION (MDR # 3007284006-2026-00194). ADDITIONALLY, 2 PATIENTS EXPERIENCED CARDIAC DEATH (MDR # 3007284006-2026-00195). ALTHOUGH GENERALIZED PATIENT INFORMATION/MEDICAL HISTORY WAS LISTED WITHIN THE JOURNAL ARTICLE, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED FOR THE ADVERSE EVENTS INVOLVING THE SPECTRANETICS DEVICES. ADDITIONALLY, THE DATE OF PROCEDURE WAS NOT LISTED FOR THESE EVENTS; THEREFORE, 13MAY2024 HAS BEEN USED, THE DATE OF PUBLICATION. HE, P ET AL_2024_DEBULKING WITH EXCIMER LASER CORONARY ANGIOPLASTY VERSUS BALLOON ANGIOPLASTY IN PATIENTS WITH IN STENT RESTENOSIS (ELDISR STUDY): A RANDOMIZED CONTROLLED TRIAL. LASERS IN SURGERY AND MEDICINE, 2025; 57:329¿338. HTTPS://DOI.ORG/10.1002/LSM.70013. THIS REPORT CAPTURES THE DEATHS THAT OCCURRED AFTER USE OF THE ELCA DEVICE. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463738 ELCA CORONARY LASER ATHERECTOMY CATHETER DEVICE, ANGIOPLASTY, LASER, CORONARY LPC SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CUTTING BALLON.| DCB (SEQUENTPLEASE, B. BRAUN SURGICAL).| NONCOMPLIANT BALLON.| OPTICAL COHERENCE TOMOGRAPHY.| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.