BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT

    MDR report key: 18339556 · Received December 15, 2023

    Report

    Report Number
    2124215-2023-70491
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    May 1, 2009
    Report Date
    December 15, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: BETWEEN MAY 2009 AND DECEMBER 2020 HAJIYEV, K; HELLSTERN, V; CIMPOCA, A; WENDL, C; BAZNER, H; HENKES, H; VON GOTTBERG, P; (2022). CAROTID ARTERY STENTING IN PATIENTS WITH SYMPTOMATIC AND ASYMPTOMATIC STENOSIS: IN-HOSPITAL CLINICAL OUTCOMES AT A SINGLE NEUROVASCULAR CENTER. JOURNAL OF CLINICAL MEDICINE, 11, 2086. HTTPS://DOI.ORG/10.3390/JCM11082086.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ACCIDENTAL DEPLOYMENT AND ADVERSE EVENTS REPORTED WITH THE USE OF WALLSTENTS, REQUIRING INTERVENTION. THE 7/40 CAROTID WALLSTENT WAS SELECTED FOR USE IN SEVERAL CAROTID ARTERY STENTING (CAS) PROCEDURES TO TREAT PATIENTS WITH SYMPTOMATIC AND ASYMPTOMATIC CAROTID ARTERY STENOSIS DURING THE COURSE OF THIS STUDY. DURING ONE PROCEDURE, THE STENT WAS ACCIDENTALLY DEPLOYED, RESULTING IN AN IATROGENIC DISSECTION. THE MEDIAN INTERVENTION TIME WAS 33 MINUTES, AND THE MEDIAN X-RAY EXPOSURE TIME WAS 19.1 MINUTES. ELEVEN PATIENTS EXHIBITED RESIDUAL STENOSIS OF GREATER THAN 50%, WHICH WAS RE-DILUTED IN A LATER SESSION. DURING SOME PROCEDURES, FIVE PATIENTS DEVELOPED INTERNAL CAROTID ARTERY (ICA) DISSECTIONS, THREE PATIENTS WERE DIAGNOSED WITH DISTAL EMBOLIZATION AS DOCUMENTED IN THE FINAL ANGIOGRAM. TWO PATIENTS EXHIBITED TRANSIENT ISCHEMIC ATTACKS (TIAS), WHERE NEW-ONSET CEREBRAL ISCHEMIA WAS NOT OBSERVED. TWENTY-THREE PATIENTS DEVELOPED NON-DISABLING STROKES. DURING A MEDIAN FOLLOW-UP OF EIGHT MONTHS, 101 PATIENTS DEVELOPED IN-STENT RESTENOSIS, OR IN-STENT THROMBOSIS. EIGHTY-THREE OF THESE PATIENTS REQUIRED FOLLOW-UP TREATMENT. THREE-HUNDRED AND SIXTY PATIENTS UNDERWENT MAGNETIC RESONANCE IMAGING (MRI) EXAMINATIONS FOLLOWING CAS THAT REVEALED SILENT DIFFUSION-WEIGHTED IMAGING MICROLESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302013 CAROTID WALLSTENT STENT, CAROTID NIM BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention