BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-ELITE LASER ATHERECTOMY CATHETER

    MDR report key: 19411496 · Received May 28, 2024

    Report

    Report Number
    3007284006-2024-00109
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    June 1, 2019
    Report Date
    July 30, 2024
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    PMA / PMN Number
    K170059
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4/H4): THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION IS UNKNOWN: MODEL/CATALOG NUMBER, SERIAL NUMBER, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. 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.

    Additional Manufacturer Narrative · 0

    E): ALTHOUGH THE JOURNAL ARTICLE ORIGINATED FROM CHINA, PHYSICIAN AND FACILITY INFORMATION UNK G2): THIS EVENT WAS CAPTURED FROM INFORMATION CONTAINED WITHIN A JOURNAL ARTICLE. GENERALIZED PATIENT INFORMATION/MEDICAL HISTORY WAS LISTED; HOWEVER, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED FOR EACH OF THE 6 ADVERSE EVENTS INVOLVING THE TURBO-ELITE DEVICE. H3): DUE TO THE LENGTH OF TIME FROM THE EVENT DATE, IT IS LIKELY THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED. H4): DEVICE MANUFACTURE DATE UNK BECAUSE LOT NUMBER UNK H6): DISSECTION IS A KNOWN RISK OF COMPLICATION WITH USE OF THE TURBO-ELITE 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 ON 14MAY2024 OF A JOURNAL ARTICLE (ELSEVIER, INC., VOLUME 104, JULY 2024; ACCEPTED 18DEC2023, PUBLISHED ONLINE 16MAR2024) TITLED "OUTCOMES OF EXCIMER LASER ABLATION COMBINED WITH DRUG-COATED BALLOON IN ATHEROSCLEROTIC LESIONS OF THE POPLITEAL ARTERY". THE ARTICLE RETROSPECTIVELY REVIEWED DATA OF PATIENTS WHO UNDERWENT EXCIMER LASER ATHERECTOMY (ELA) COMBINED WITH DRUG COATED BALLOON (DCB) IN THE POPLITEAL ARTERY. THE STUDY ENROLLED 61 PATIENTS IN 2 CENTERS (LOCATIONS UNK), HAVING ATHEROSCLEROTIC STENOTIC OR OCCLUSIVE LESIONS INVOLVING THE POPLITEAL ARTERY, CONFIRMED BY ANGIOGRAPHY. THE ELA PROCEDURES WERE PERFORMED USING SPECTRANETICS CVX-300 EXCIMER LASER SYSTEMS AND SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETERS, ADVANCED OVER THE WIRE TO THE PROXIMAL END OF THE LESION, WHERE LASING WAS ACTIVATED. WHEN THE LESION COULD NOT BE CROSSED, A STEP BY STEP TECHNIQUE WAS USED (ADVANCING THE TURBO-ELITE INTO THE LESION WITHOUT ANY WIRE SUPPORT). AFTER ELA, ANGIOGRAPHY WAS PERFORMED TO CHECK FOR RESIDUAL STENOSIS AND POTENTIAL COMPLICATIONS. LASING WAS REPEATED AS NECESSARY AND WAS DEEMED TO BE COMPLETE AFTER A FLOW CHANNEL WAS CREATED AND THE RESIDUAL STENOSIS WAS <30%. THE DCB (ACOTEC, BEIJING, CHINA) WAS THEN APPLIED. AN ABBOTT SUPERA STENT WAS DEPLOYED IF FLOW-LIMITING DISSECTIONS OR RESIDUAL ARTERIAL STENOSIS >30% WAS OBSERVED. DISTAL EMBOLIC PROTECTION DEVICES WERE USED AT THE SURGEON''S DISCRETION. THREE PATIENTS HAD FLOW LIMITING DISSECTIONS POST-ELA, AND A SELF-EXPANDING STENT WAS DEPLOYED IN EACH OF THEM (MDRS #3007284006-2024-00110, AND #3007284006-2024-00111). THREE PATIENTS SUFFERED FROM PROCEDURE-RELATED DISTAL EMBOLIZATIONS. EMBOLI LODGED IN THE TIBIO-FIBULAR TRUNK, TREATED SUCCESSFULLY WITH REPEAT ELA (MDR #3007284006-2024-00112), THE POSTERIOR TIBIAL ARTERY (MDR #3007284006-2024-00113), AND THE PERONEAL ARTERY (MDR #3007284006-2024-00114). THE LAST TWO PATIENTS WERE TREATED CONSERVATIVELY WITH ORAL ANTICOAGULATION. ALTHOUGH GENERALIZED PATIENT INFORMATION/MEDICAL HISTORY WAS LISTED WITHIN THE JOURNAL ARTICLE, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED FOR EACH OF THE 6 ADVERSE EVENTS INVOLVING THE TURBO-ELITE DEVICE. ADDITIONALLY, THE DATE OF PROCEDURE WAS NOT LISTED FOR THESE 6 EVENTS; THEREFORE, 01JUN2019 HAS BEEN USED, THE FIRST DAY OF THE DATABASE REVIEW. THIS REPORT CAPTURES #1 OF THE FLOW LIMITING DISSECTIONS WHICH WERE DETECTED POST-ELA WITH USE OF THE TURBO-ELITE, REQUIRING INTERVENTION OF A SELF EXPANDING STENT. THERE WAS NO ALLEGED MALFUNCTION OF THE TURBO-ELITE DEVICE IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585334 TURBO-ELITE LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ACOTEC DRUG COATED BALLOON.| GUIDE CATHETER MANUFACTURER/SIZE UNK.| GUIDE WIRE MANUFACTURER/SIZE UNK.| INTRODUCER SHEATH MANUFACTURER/SIZE UNK.| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.