BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELCA CORONARY LASER ATHERECTOMY CATHETER

    MDR report key: 25104666 · Received May 6, 2026

    Report

    Report Number
    3007284006-2026-00187
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    March 6, 2019
    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 AGE 67.4 (0.9MM ELCA GROUP) AND 66.1 (1.4MM ELCA GROUP). A3A) PATIENT SEX - SEX OF MAJORITY OF PATIENTS INVOLVED: 43/51 MALES IN THE 0.9MM ELCA GROUP. 29/39 MALES IN THE 1.4MM GROUP. 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 DEFECTS (OCCLUSION), DISSECTION, MYOCARDIAL INFARCTION, AND CORONARY ARTERY BYPASS GRAFT SURGERY 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 06MAR2019) ¿COMPARISON OF 0.9-MM AND 1.4-MM CATHETERS IN EXCIMER LASER CORONARY ANGIOPLASTY FOR ACUTE MYOCARDIAL INFARCTION¿. THE STUDY RETROSPECTIVELY AIMED TO EVALUATE EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) AS A UNIQUE REVASCULARIZATION MODALITY THAT CAN VAPORIZE PLAQUE AND THROMBUS. COMPARED TO THROMBUS ASPIRATION THERAPY, ELCA IS REPORTED TO PROVIDE BETTER MICROCIRCULATION AND REDUCED PERIPHERAL EMBOLISM IN TREATMENT FOR ACUTE CORONARY SYNDROME. A TOTAL OF 90 ACUTE MYOCARDIAL INFARCTION (AMI) PATIENTS WHO UNDERWENT PRIMARY PERCUTANEOUS CORONARY INTERVENTION WITH EXCIMER LASER WERE ENROLLED IN THE STUDY AUGUST 2013 AND MARCH 2017. ALL LESIONS WERE SEQUENTIALLY TREATED WITH SPECTRANETICS ELCA LASER ATHERECTOMY CATHETERS. PROCEDURAL COMPLICATIONS INCLUDED 8 SLOW-FLOW OR NO-REFLOW, 1 MAJOR DISSECTION, 1 ULCERATION, 2 TARGET LESION REVASCULARIZATIONS, 1 MYOCARDIAL INFARCTION, AND 1 CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY (MDR # 3007284006-2026-00187). ADDITIONALLY, THERE WERE 3 CARDIAC DEATHS (MDR # 3007284006-2026-00188). 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, 06MAR2019 HAS BEEN USED, THE DATE OF PUBLICATION. NAGAMINE, SHO,ASHIKAGA, TAKASHI,MASUDA, SHINICHIRO,KOMIYAMA, KOTA,TSUCHIYAMA, TAKAAKI,SHIBUI, TAKASHI,HIRAO, KENZO. 2019. COMPARISON OF 0.9-MM AND 1.4-MM CATHETERS IN EXCIMER LASER CORONARY ANGIOPLASTY FOR ACUTE MYOCARDIAL INFARCTION. LASERS IN MEDICAL SCIENCE, 34(9): 1747-1754. HTTPS://LINK.SPRINGER.COM/ARTICLE/10.1007/S10103-019-02772-X. THIS REPORT CAPTURES THE SERIOUS INJURIES 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
    508838 ELCA CORONARY LASER ATHERECTOMY CATHETER DEVICE, ANGIOPLASTY, LASER, CORONARY LPC SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1