BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELCA CORONARY LASER ATHERECTOMY CATHETER

    MDR report key: 24974848 · Received April 23, 2026

    Report

    Report Number
    3007284006-2026-00160
    Event Type
    Death
    Date Received
    April 23, 2026
    Date of Event
    April 24, 2025
    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 - MEAN AGE 66 ± 12 YEARS A3A) PATIENT SEX - MAJORITY SEX: 206 MALES, 50 FEMALES A4) PATIENT WEIGHT - MEAN BMI REPORTED 24.5 ± 4.0 KG/M² 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 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 24APR2025) ¿EFFICACY AND SAFETY OF EXCIMER LASER CORONARY ATHERECTOMY IN ACUTE CORONARY SYNDROME: REAL WORLD EVIDENCE FROM A PROPENSITY ADJUSTED ANALYSIS¿. THE STUDY RETROSPECTIVELY AIMED TO EVALUATE THE CLINICAL CHARACTERISTICS OF PATIENTS WHO UNDERWENT PRIMARY PCI WITH ELCA IN THE SETTING OF ACS, AND TO ASSESS THE IMPACT OF ELCA ON CLINICAL OUTCOMES. A TOTAL OF 586 PATIENTS WHO UNDERWENT PRIMARY PCI, STRATIFIED BY ELCA USE WERE ENROLLED IN THE STUDY BETWEEN (B)(6) 2017 AND (B)(6) 2023. ALL LESIONS WERE SEQUENTIALLY TREATED WITH SPECTRANETICS ELCA LASER ATHERECTOMY CATHETERS. PROCEDURAL COMPLICATIONS INCLUDED SLOW FLOW PHENOMENON IN 67 PATIENTS, 13 PATIENTS EXPERIENCED DISTAL EMBOLIZATION, CORONARY PERFORATION OCCURRED IN 2 PATIENTS, 16 PATIENTS EXPERIENCED MAJOR ADVERSE CARDIOVASCULAR EVENT (MACE), 7 PATIENTS REQUIRED TARGET LESION REVASCULARIZATION, AND 2 PATIENTS EXPERIENCED MYOCARDIAL INFARCTIONS (MDR #3007284006-2026-00159). ADDITIONALLY, THERE WERE 9 CARDIAC DEATHS (MDR # .). 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, 24APR2025 HAS BEEN USED, THE DATE OF PUBLICATION. IIYA M, ARAI R, NAKADA K, ET AL. CATHETER CARDIOVASC INTERV. 2025; 106:359¿366. DOI:10.1002/CCD.31557. 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
    357618 ELCA CORONARY LASER ATHERECTOMY CATHETER DEVICE, ANGIOPLASTY, LASER, CORONARY LPC SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DRUG-COATED BALLOONS| DRUG-ELUTING STENTS| GUIDE CATHETERS (6¿7 FR)| IVUS| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| THROMBUS ASPIRATION DEVICES