BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX CAROTID STENT SYSTEM

    MDR report key: 22059943 · Received May 21, 2025

    Report

    Report Number
    2183870-2025-00248
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    December 21, 2024
    Report Date
    May 21, 2025
    Manufacturer
    COVIDIEN
    Product Code
    NIM
    PMA / PMN Number
    P060001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF CAROTID STENTING IN PATIENTS WITH CONTRALATERAL INTERNAL CAROTID ARTERY OCCLUSION: A RETROSPECTIVE SINGLE-CENTER ANALYSIS AND 22 YEARS OF EXPERIENCE NEURORADIOLOGY (2025) 67:393¿401 HTTPS://DOI.ORG/10.1007/S00234-024-03524-7 A2 AVERAGE AGE A3 MAJORITY SEX 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

    ABSTRACT PURPOSE PATIENTS WITH CONTRALATERAL CAROTID ARTERY OCCLUSION (CCO) REPRESENT A SUBGROUP OF PATIENTS AT RISK FOR REVASCULARIZATION PROCEDURES. THE CHOICE OF APPROPRIATE REVASCULARIZATION PROCEDURE (CAROTID ENDARTERECTOMY (CEA) OR CAROTID ARTERY STENTING (CAS) IN THESE PATIENTS IS CONTROVERSIAL. THE AIM OF THIS STUDY IS TO SHARE THE RESULTS OF CLINICAL AND RADIOLOGICAL FOLLOW-UP AFTER CAS IN THESE PATIENTS AND TO CONTRIBUTE TO THE LITERATURE BY EVALUATING THE EFFICACY AND SAFETY OF STENTING. METHODS IN OUR STUDY, THE CLINICAL AND RADIOLOGICAL DATA OF 145 PATIENTS WITH CCO AND 145 AGE-GENDER-MATCHED PATIENTS WITHOUT CCO WHO UNDERWENT ELECTIVE CAS IN THE INTERVENTIONAL NEURORADIOLOGY CLINIC BETWEEN 2001 AND 2023 WERE RETROSPECTIVELY ANALYZED. A COMPARISON WAS MADE BETWEEN SHORT- AND LONG-TERM OUTCOMES BETWEEN THE TWO GROUPS. RESULTS THE OVERALL TECHNICAL SUCCESS RATE OF CAS WAS 99.7% AND THE 30-DAY ALL-CAUSE MORTALITY RATE WAS 1.4%. THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE TWO GROUPS IN TERMS OF EARLY-TERM (IN TRA-PROCEDURAL THROMBOEMBOLIC EVENTS, POST-PROCEDURAL SYMPTOMATIC HYPERPERFUSION, INTRAPARENCHYMAL HEMORRHAGE, MAJOR AND MINOR ISCHEMIC STROKE, EARLY-TERM MORTALITY RATE) AND LONG-TERM (INTIMAL HYPERPLASIA, RESIDUAL STENOSIS, MAJOR AND MINOR ISCHEMIC STROKE AND LO NGTERM ALL-CAUSE MORTALITY RATE) (P>0.05). CONCLUSION IN OUR EXPERIENCE, IT WAS CONCLUDED THAT CAS PERFORMED BY AN EXPERIENCED INTERVENTIONAL NEURORADIOLOGY TEAM IN PATIENTS WITH CCO DOES NOT POSE AN ADDITIONAL RISK. SINCE CCO POSES A RISK FOR CAE, CAS MAY BE A MORE ACCEPTABLE TREATMENT MODALITY IN THESE PATIENTS DUE TO LESS PERIOPERATIVE RISK. HOWEVER, FURTHER RESEARCH IS REQUIRED TO SUPPORT OUR FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50962 PROTEGE RX CAROTID STENT SYSTEM STENT, CAROTID NIM COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention