BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX CAROTID STENT SYSTEM

    MDR report key: 22204613 · Received June 13, 2025

    Report

    Report Number
    2183870-2025-00304
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    February 28, 2025
    Report Date
    June 13, 2025
    Manufacturer
    COVIDIEN
    Product Code
    NIM
    PMA / PMN Number
    P060001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CAROTID ARTERY STENTING WITH OPEN VS CLOSED STENT CELL CONFIGURATIONS IN THE CREST-2 REGISTRY 2025 THE AUTHOR(S). PUBLISHED BY ELSEVIER INC. ON BEHALF OF THE SOCIETY FOR VASCULAR SURGERY. THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY LICENSE (HTTP://CREATIVECOMMONS.ORG/LICENSES/BY/4.0/). HTTPS://DOI.ORG/10.1016/J.JVS.2025.02.025 A2 AVERAGE AGE A3 MAJORITY GENDER B3 DATE OF PUBLICATION MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    OBJECTIVE INTRAPROCEDURAL ATHEROEMBOLIZATION DURING CAROTID ARTERY STENTING (CAS) CAN BE REDUCED THROUGH CAREFUL PATIENT SELECTION, CONSIDERATION OF VASCULAR ANATOMY AND LESION CHARACTERISTICS, OPERATOR AND INSTITUTIONAL EXPERIENCE, PERI-PROCEDURAL ANTITHROMBOTIC AND ANTIPLATELET THERAPY, AND USE OF EMBOLIC PROTECTION. HOWEVER, CAS CAN ALSO RESULT IN STROKE AS THE STENT IS DEPLOYED AND EMBOLIC PROTECTION WITHDRAWN. THE FREE-CELL AREA OF MOST CLOSED-CELL STENTS IS 5 MM2, AND =5 MM2 FOR OPEN-CELL STENTS. THE LARGER AREA MAY PERMIT ESCAPE OF MORE ATHEROMATOUS DEBRIS. COMPARISONS OF CLINICAL OUTCOMES BETWEEN CLOSED-CELL AND OPEN-CELL STENTS HAVE BEEN INCONCLUSIVE. THE AIM OF THIS STUDY IS TO COMPARE CLINICAL OUTCOMES ASSOCIATED WITH CAS USING OPEN-CELL VS CLOSED-CELL STENTS. METHODS THE CREST-2-REGISTRY (C2R) ENROLLS ASYMPTOMATIC AND SYMPTOMATIC PATIENTS FOR WHOM CAS IS FAVORED BECAUSE OF HIGH RISK FOR SURGERY OR PATIENT PREFERENCE. C2R IMPLEMENTS OPERATOR- AND SITE-CREDENTIALING, CAREFUL LESION SELECTION, AND STANDARDIZED PROCEDURAL PROTOCOLS. PATIENT CHARACTERISTICS, PROCEDURAL DETAILS, AND OUTCOMES ARE RECORDED. INTERVENTIONISTS MAY USE UNITED STATES FOOD AND DRUG ADMI NISTRATION-APPROVED DEVICES INCLUDING OPEN-CELL STENTS (RX ACCULINK [ABBOTT VASCULAR], PRECISE PRO RX [CORDIS-CARDINAL HEALTH], AND PROTÉGÉ RX [MEDTRONIC/COVIDIEN]), OR CLOSED-CELL STENTS (XACT [ABBOTT VASCULAR] AND WALLSTENT MONORAIL ENDOPROSTHESIS [BOSTON SCIENTIFIC]). MULTIVARIABLE LOGISTIC REGRESSION WAS USED TO ASSESS RELATE STENT CELL CONFIGURATION TO PERI-PROCEDURAL (30-DAY) STROKE OR DEATH (SD). RESULTS OF 5307 PROCEDURES PERFORMED BY 163 INTERVENTIONISTS ACROSS 101 CLINICAL CENTERS, 2054 (38.7%) RECEIVED OPEN-CELL STENTS, AND 3253 (61.3%) RECEIVED CLOSED-CELL STENTS. IN THE PERIPROCEDURAL PERIOD, 91 PATIENTS (1.7%) EXPERIENCED A STROKE (3 WERE FATAL), AND 16 PATIENTS DIED WITHOUT EXPERIENCING STROKES (0.4%). AFTER ADJUSTING FOR AGE, SEX, SYMPTOMATIC STATUS, AND CASE URGENCY, AND FOR EFFECT-MODIFICATION BY INDICATION, PERIPROCEDURAL SD WAS SIGNIFICANTLY HIGHER WHEN AN OPEN-CELL STENT WAS PLACED IN A PRIMARY LESION COMPARED WITH CLOSED-CELL STENTS (3.5 EVENTS PER 100 PROCEDURES USING OPEN-CELL STENTS [95% CONFIDENCE INTERVAL [CI], 2.6-4.7] VS 2.2% [95% CI, 1.6-3.0] USING CLOSED-CELL STENTS (ODDS RATIO, 1.59; 95% CI, 1.13-2.23; P .01). PERIPROCEDURAL SD WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN STENT TYPES WHEN PLACED IN A RESTENOTIC LESION (1.2% [95% CI, 0.4-3.3]) USING OPEN-CELL STENTS VS 4.0% (95% CI, 2.2-7.2) USING CLOSED-CELL STENTS (ODDS RATIO, 0.31; 95% CI, 0.09-1.01; P = .052). CONCLUSIONS STENT DESIGN INFLUENCES PERIPROCEDURAL STROKE OR DEATH IN CAROTID STENTING. CLOSED-CELL STENTS ARE ASSOCIATED WITH A LOWER EVENT RATE WHEN TREATING PRIMARY ATHEROSCLEROSIS, BUT NOT IN THE SETTING OF RESTENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635747 PROTEGE RX CAROTID STENT SYSTEM STENT, CAROTID NIM COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention