BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELCA CORONARY LASER ATHERECTOMY CATHETER

    MDR report key: 24889252 · Received April 15, 2026

    Report

    Report Number
    3007284006-2026-00142
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    December 21, 2020
    Report Date
    October 1, 2025
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    LPC
    PMA / PMN Number
    P910001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE - AVERAGE PATIENT AGE: MEAN 67. A3A) PATIENT SEX - SEX OF MAJORITY OF PATIENTS INVOLVED: 36 MALE, 34 FEMALE. A3B-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 JAPAN, 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, FILLING DEFECT (OCCLUSION), DISSECTION, AND EMBOLISM ARE LISTED AS POTENTIAL ADVERSE EVENTS WITH USE OF THE ELCA 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 21DEC2020) ¿BENEFITS OF EXCIMER LASER CORONARY ANGIOPLASTY OVER THROMBUS ASPIRATION THERAPY FOR PATIENTS WITH ACUTE CORONARY SYNDROME AND THROMBOLYSIS IN MYOCARDIAL INFARCTION FLOW GRADE 0¿. THE STUDY RETROSPECTIVELY ANALYZED PATIENTS WHO UNDERWENT PCI, AND WHO HAD A THROMBOLYSIS IN MYOCARDIAL INFARCTION FLOW (TIMI) GRADE 0 ON THE FIRST CONTRAST INJECTION WITHIN 24 HOURS OF ONSET. A TOTAL OF 113 PATIENTS WERE ENROLLED IN THE STUDY BETWEEN MARCH 2011 TO MARCH 2020. ALL LESIONS WERE SEQUENTIALLY TREATED WITH SPECTRANETICS ELCA LASER ATHERECTOMY CATHETERS, MANUAL THROMBUS ASPIRATION THERAPY (TA) BEFORE BALLOON ANGIOPLASTY, OR STENTING. PROCEDURAL COMPLICATIONS INCLUDED 1 SLOW FLOW/NO FLOW, 1 DISSECTION, AND 1 DISTAL EMBOLIZATION (MDR #3007284006-2026-00142). ADDITIONALLY, THERE WAS 3 CARDIOVASCULAR DEATHS THAT OCCURRED POST-PROCEDURE (MDR #3007284006-2026-00143). 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, 21DEC2020 HAS BEEN USED, THE DATE OF PUBLICATION. ARAI, T, TSUCHIYAMA, T, INAGAKI, D, YOSHIDA, K, FUKAMIZU, S_2022_BENEFITS OF EXCIMER LASER CORONARY ANGIOPLASTY OVER THROMBUS ASPIRATION THERAPY FOR PATIENTS WITH ACUTE CORONARY SYNDROME AND THROMBOLYSIS IN MYOCARDIAL INFARCTION FLOW GRADE 0. LASERS IN MEDICAL SCIENCE (2023) 38:13. HTTPS://DOI.ORG/10.1007/S10103-022-03691-0 THIS REPORT CAPTURES THE SLOW FLOW/NO FLOW, DISSECTION, AND DISTAL EMBOLIZATION 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
    356346 ELCA CORONARY LASER ATHERECTOMY CATHETER DEVICE, ANGIOPLASTY, LASER, CORONARY LPC SPECTRANETICS CORPORATION

    Patients

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