BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELCA CORONARY LASER ATHERECTOMY CATHETER

    MDR report key: 24889059 · Received April 15, 2026

    Report

    Report Number
    3007284006-2026-00137
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    March 2, 2021
    Report Date
    October 1, 2025
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    LPC
    PMA / PMN Number
    P910001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE - AVERAGE PATIENT AGE: MEAN 67.9. A3A) PATIENT SEX - SEX OF MAJORITY OF PATIENTS INVOLVED: 32 MALE, 17 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 THE UNITED KINGDOM, 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, MYOCARDIAL INFARCTION AND THROMBUS 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 02MAR2021) ¿CONTEMPORARY USE OF EXCIMER LASER IN PERCUTANEOUS CORONARY INTERVENTION WITH INDICATIONS, PROCEDURAL CHARACTERISTICS, COMPLICATIONS AND OUTCOMES IN A UNIVERSITY TEACHING HOSPITAL¿. THE STUDY RETROSPECTIVELY INVESTIGATES THE INDICATIONS, PROCEDURAL CHARACTERISTICS, COMPLICATIONS AND OUTCOMES OF ELCA IN A CONTEMPORARY CORONARY INTERVENTIONAL PRACTICE. A TOTAL OF 50 PATIENTS WERE ENROLLED IN THE STUDY BETWEEN JANUARY 2013 AND JANUARY 2019. ALL LESIONS WERE SEQUENTIALLY TREATED WITH SPECTRANETICS ELCA LASER ATHERECTOMY CATHETERS. POST-PROCEDURAL COMPLICATIONS INCLUDED 1 TRANSIENT ISCHAEMIC ATTACK (TIA) AND 1 STENT THROMBOSIS LEADING TO MYOCARDIAL INFARCTION (MI) (MDR # 3007284006-2026-00137). ADDITIONALLY, THERE WAS 1 DEATH THAT OCCURRED DURING THE PROCEDURE IN A PATIENT WITH CARDIOGENIC SHOCK IN THE CONTEXT OF A LATE PRESENTING MI (MDR # 3007284006-2026-00138). 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, 02MAR2021 HAS BEEN USED, THE DATE OF PUBLICATION. JAWAD-UL-QAMAR M ET AL_2021_ CONTEMPORARY USE OF EXCIMER LASER IN PERCUTANEOUS CORONARY INTERVENTION WITH INDICATIONS, PROCEDURAL CHARACTERISTICS, COMPLICATIONS AND OUTCOMES IN A UNIVERSITY TEACHING HOSPITAL. OPEN HEART 2021;8:E001522. DOI:10.1136/OPENHRT-2020-001522 THIS REPORT CAPTURES THE 1 TIA AND 1 STENT THROMBOSIS LEADING TO MI 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
    319650 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