BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER FX

    MDR report key: 23108894 · Received September 22, 2025

    Report

    Report Number
    2183870-2025-00448
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    April 12, 2025
    Report Date
    December 15, 2025
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    PMA / PMN Number
    K063204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    LITERATURE TITLE UNCOMMON CAROTID ARTERY STENTING COMPLICATIONS: A SERIES BY IMAGES A. UNCOMMON CAROTID ARTERY STENTING COMPLICATIONS: A SERIES BY IMAGES. J. PERS. MED. 2024, 14, 250. HTTPS://DOI.ORG/10.3390/ JPM14030250 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.

    Additional Manufacturer Narrative · 0

    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

    A 73-YEAR-OLD MAN WITH PREVIOUS PERCUTANEOUS CORONARY INTERVENTION (PCI) AND PERIPHERAL LOWER LIMB ANGIOPLASTY WAS SCHEDULED FOR RIGHT CAS AFTER HE COMPLAINED OF A MINOR STROKE CHARACTERIZED BY LEFT ARM HYPOSTHENIA AND MULTIPLE RIGHT CORTICO-CEREBRAL ISCHEMIC LESIONS ON CEREBRAL CT SCAN. THE PROCEDURE WAS PERFORMED THROUGH A 6 F INTERNAL MAMMARY (IM) GUIDING CATHETER ADVANCED INTO THE DISTAL RIGHT CCA. THE STENOSIS WAS CROSSED WITH A 0.014¿ CHOICE EXTRA SUPPORT WIRE (BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA) AND A 6 MM SPIDER-FX FILTER (MEDTRONIC, INC. USA) WAS DEPLOYED OVER THIS WIRE UP TO THE DISTAL PORTION OF THE ICA. AFTER STENTING BY A 7.0 × 40 MM CAROTID WALL STENT (BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA), A FILTER DISCONNECTION WAS IDENTIFIED A FEW MILLIMETRES AWAY FROM THETRANSITION BETWEEN THE FILTER¿S BASKET AND THE FILTER WIRE. THE IM GUIDING CATHETER WAS ADVANCED THROUGH THE STENT CLOSE TO THE FILTER AND IT WAS RECAPTURED USING A 4 MM SNARE DEVICE. DURING THE ATTEMPT TO RECAPTURE THE FILTER, THE PATIENT COMPLAINED OF APHASIA WHICH RESOLVED WITHIN 5 H. DESPITE THE FACT THAT A STENT WAS NOT PERFORMED POST DILATATION, THE PERIPROCEDURAL DUPLEX SCAN SHOWED A SA TISFACTORY STENT EXPANSION AS THE MINIMAL LUMEN STENT DIAMETER WAS 4.2 MM, AND THE SPECTRAL DOPPLER PEAK SYSTOLIC VELOCITY WAS NORMAL. THE CEREBRAL CT SCAN PERFORMED ON THE DAY AFTER THE PROCEDURE DID NOT SHOW ANY CEREBRAL ACUTE ISCHEMIC INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027516 SPIDER FX TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention