BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIST

    MDR report key: 21729759 · Received March 31, 2025

    Report

    Report Number
    2029214-2025-00805
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    July 5, 2024
    Report Date
    March 31, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    PND
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: UNK-NV-RIST (LOT: UNKNOWN); IMPLANT DATE: N/A; EXPLANT DATE: N/A. G2: CITATION: AUTHORS: NAAMANI, K. E., ROY, J. M., MOMIN, A. A, TEICHNER, E. M., SIOUTAS, G. S., SALEM, M. M., GASKINS, W., SAADAT, N., NGUYEN, A. M, TJOUMAKARIS, S. I., GOOCH, M. R., ROSENWASSER, R. H., SRINIVASAN, V., JAN. THE ERA OF RADIAL-SPECIFIC CATHETERS: A MULTICENTER COMPARISON OF THE ARMADILLO AND RIST CATHETERS IN TRANSRADIAL PROCEDURES. OPERATIVE NEUROSURGERY 28:159¿164 2025. DOI: 10.1227/ONS.0000000000001256. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    THE ERA OF RADIAL-SPECIFIC CATHETERS: A MULTICENTER COMPARISON OF THE ARMADILLO AND RIST CATHETERS IN TRANSRADIAL PROCEDURE THE TIME FRAME OF THIS STUDY WAS: THE STUDY WAS CONDUCTED BETWEEN 2021 AND 2024 MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE STUDY INVOLVES CATHETERS FROM MULTIPLE MANUFACTURERS: ARMADILLO (Q¿APEL MEDICAL INC.) AND RIST (MEDTRONIC) DEATHS OCCURRED IN THE STUDY POPULATION: THE DOCUMENT DOES NOT MENTION ANY OCCURRENCES OF DEATHS. AMONG PATIENT ADVERSE EVENTS INCLUDED: ACCESS SITE COMPLICATIONS - RADIAL ARTERY OCCLUSION, RADIAL ARTERY DISSECTION, RADIAL ARTERY SPASM, HEMATOMA FORMATION AND CATHETER ENTRAPMENT, AND TECHNICAL COMPLICATIONS RELATED TO THE CATHETER. NEUROLOGICAL COMPLICATIONS - STROKE, HEMORRHAGE, CAROTID DISSECTION, OR FORMATION OF A PSEUDOANEURYSM IN AN ARTERY APART FROM THE ACCESS SITE, RAYMOND ROY OCCLUSION CLASS 3 NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912261 RIST MIDLINE CATHETER PND MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RIST UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening