BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELCA CORONARY LASER ATHERECTOMY CATHETER

    MDR report key: 25102150 · Received May 6, 2026

    Report

    Report Number
    3007284006-2026-00184
    Event Type
    Death
    Date Received
    May 6, 2026
    Date of Event
    April 16, 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: THE MEAN AGE WAS 67.9±11.4. A3A) PATIENT SEX - SEX OF MAJORITY OF PATIENTS INVOLVED: 32/50 MALE, 18/50 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, DEATH AND MYOCARDIAL INFARCTION 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 16APR2021) ¿CONTEMPORARY USE OF EXCIMER LASER IN PERCUTANEOUS CORONARY INTERVENTION WITH INDICATIONS, PROCEDURAL CHARACTERISTICS, COMPLICATIONS AND OUTCOMES IN A UNIVERSITY TEACHING HOSPITAL¿. THE STUDY RETROSPECTIVELY AIMED TO EXAMINE HOW EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CAN BE USED AS AN ADJUNCTIVE PERCUTANEOUS CORONARY INTERVENTION TREATMENT FOR CHALLENGING, HEAVILY CALCIFIED LESIONS. A TOTAL OF 50 PATIENTS TREATED WITH ELCA WERE ENROLLED IN THE STUDY BETWEEN JANUARY 2013 AND JANUARY 2019. ALL LESIONS WERE SEQUENTIALLY TREATED WITH SPECTRANETICS ELCA LASER ATHERECTOMY CATHETERS. PROCEDURAL COMPLICATIONS INCLUDED 2 CORONARY DISSECTIONS AND 1 PERFORATION. THIRTY-DAY OUTCOMES INCLUDED ONE TRANSIENT ISCHAEMIC ATTACK AND ONE STENT THROMBOSIS LEADING TO MYOCARDIAL INFARCTION (MI) AND BOTH THESE PATIENTS MADE FULL RECOVERY (MDR #3007284006-2026-00183). ADDITIONALLY, THERE WAS 1 DEATH DURING THE PROCEDURE IN A PATIENT WITH CARDIOGENIC SHOCK IN THE CONTEXT OF A LATE PRESENTING MI AND ONE DEATH OF UNKNOWN CAUSES AT 30-DAY FOLLOW UP (MDR #3007284006-2026-00184). 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, 16APR2021 HAS BEEN USED, THE DATE OF PUBLICATION. JAWAD-UL-QAMAR, MUHAMMAD,SHARMA, HARISH,VETRUGNO, VINCENZO,SANDHU, KULLY,LUDMAN, PETER F,DOSHI, SAGAR N,TOWNEND, JONATHAN N,OSHEIBA, MOHAMMED,ZAPHIRIOU, ALEX,KHAN, SOHAIL Q. 2021. CONTEMPORARY USE OF EXCIMER LASER IN PERCUTANEOUS CORONARY INTERVENTION WITH INDICATIONS, PROCEDURAL CHARACTERISTICS, COMPLICATIONS AND OUTCOMES IN A UNIVERSITY TEACHING HOSPITAL. OPEN HEART, 8(1): E001522. HTTPS://OPENHEART.BMJ.COM/CONTENT/8/1/E001522. 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
    72888 ELCA CORONARY LASER ATHERECTOMY CATHETER DEVICE, ANGIOPLASTY, LASER, CORONARY LPC SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CORONARY ROTATIONAL ATHERECTOMY.| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.