BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELCA CORONARY LASER ATHERECTOMY CATHETER

    MDR report key: 25106203 · Received May 6, 2026

    Report

    Report Number
    3007284006-2026-00197
    Event Type
    Death
    Date Received
    May 6, 2026
    Date of Event
    February 18, 2018
    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: 67 YEARS. A3A) PATIENT SEX - 132 MALES, 36 FEMALES. A4) PATIENT WEIGHT - 24.63 (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 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, 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 18FEB2018) ¿REAL-LIFE EXPERIENCE OF A STENT-LESS REVASCULARIZATION STRATEGY USING A COMBINATION OF EXCIMER LASER AND DRUG-COATED BALLOON FOR PATIENTS WITH ACUTE CORONARY SYNDROME¿. THE STUDY RETROSPECTIVELY AIMED TO TEST A NOVEL STENT-LESS REVASCULARIZATION STRATEGY USING A COMBINATION OF EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) AND DRUG-COATED BALLOON (DCB) FOR PATIENTS WITH ACUTE CORONARY SYNDROME (ACS). A TOTAL OF 168 ACS PATIENTS WHO PLANNED TO RECEIVE EITHER A DCB APPLICATION FOLLOWING ELCA WITHOUT A STENT IMPLANTATION OR CONVENTIONAL REVASCULARIZATION WITH A CORONARY STENT WERE ENROLLED IN THE STUDY BETWEEN FEBRUARY 2014 AND JANUARY 2016. ALL LESIONS WERE SEQUENTIALLY TREATED WITH SPECTRANETICS ELCA LASER ATHERECTOMY CATHETERS. PROCEDURAL COMPLICATIONS INCLUDED 8 CORONARY DISSECTIONS, 4 RESIDUAL THROUMBUS, 1 CORONARY PERFORATION, AND 26 UNPLANNED STENT IMPLANTATIONS. DURING THE FOLLOW-UP PERIOD 9 PATIENTS REQUIRED TARGET LESION REVASCULARIZATIONS, AND 2 BLEEDING EVENTS OCCURRED REQUIRING A TRANSFUSION OR SURGICAL REPAIR (MDR # 3007284006-2026-00196). ADDITIONALLY, 1 PATIENT EXPERIENCED DEATH DUE TO HEART FAILURE. 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, 18FEB2018 HAS BEEN USED, THE DATE OF PUBLICATION. HARIMA, AYAKO,SAIRAKU, AKINORI,INOUE, ICHIRO,NISHIOKA, KENJI,OKA, TOSHIHARU,NAKAMA, YASUHARU,DAI, KAZUOKI,OHI, KUNIOMI,HASHIMOTO, HARUKI,KIHARA, YASUKI. 2018. REAL-LIFE EXPERIENCE OF A STENT-LESS REVASCULARIZATION STRATEGY USING A COMBINATION OF EXCIMER LASER AND DRUG-COATED BALLOON FOR PATIENTS WITH ACUTE CORONARY SYNDROME. DOI: 10.1111/JOIC.12495. THIS REPORT CAPTURES THE DEATH 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
    156553 ELCA CORONARY LASER ATHERECTOMY CATHETER DEVICE, ANGIOPLASTY, LASER, CORONARY LPC SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PACLITAXEL-COATED BALLOON (SEQUENT PLEASE).| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.| STENTS.