BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS TRANSFEMORAL SHEATH

    MDR report key: 24584673 · Received March 12, 2026

    Report

    Report Number
    2015691-2026-13160
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    May 1, 2016
    Report Date
    April 17, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE OF THE EVENT IS UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM MAY 2016 AND OCTOBER 2022. THEREFORE, MAY 1, 2016, WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT SHEATH MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS TRANSFEMORAL SHEATH. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS TRANSFEMORAL SHEATH: K093877-RETROFLEX 3TM INTRODUCER SHEATH SET; K200258-EDWARDS EXPANDABLE INTRODUCER SHEATH SET AND K200258-EDWARDS ESHEATH+ INTRODUCER SET. INVESTIGATION IS ONGOING. LITERATURE REFERENCE: BELAHNECH, Y., MARTI-AGUASCA, G., DOS-SUBIRA, L., BETRIAN-BLASCO, P., GARCIA DEL BLANCO, B., CALVO-BARCELO, M., ... & FERREIRA-GONZALEZ, I. (2025). MID-TERM OUTCOMES OF PERCUTANEOUS PULMONARY VALVE REPLACEMENT WITH EDWARDS-SAPIEN BIOPROSTHESIS IN NATIVE RIGHT VENTRICULAR OUTFLOW TRACT. SCIENTIFIC REPORTS, 15(1), 3977.

    Description of Event or Problem · 0

    THROUGH REVIEW OF MEDICAL ARTICLE "MID-TERM OUTCOMES OF PERCUTANEOUS PULMONARY VALVE REPLACEMENT WITH EDWARDS-SAPIEN BIOPROSTHESIS IN NATIVE RIGHT VENTRICULAR OUTFLOW TRACT", BY CORRESPONDING AUTHOR DR. YASSIN BELAHNECH, THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: ONE PATIENT WITH A 20, 23, 26, OR 29 MM SAPIEN XT OR SAPIEN 3 VALVE IMPLANTED IN THE PULMONIC POSITION VIA THE FEMORAL OR JUGULAR VEIN HAD A VASCULAR COMPLICATION REQUIRING VASCULAR SURGERY AS A PERIPROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641882 UNKNOWN EDWARDS TRANSFEMORAL SHEATH INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention