BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS ESHEATH+ INTRODUCER SET

    MDR report key: 23324966 · Received October 17, 2025

    Report

    Report Number
    2015691-2025-08580
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    September 24, 2025
    Report Date
    December 21, 2025
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DYB
    UDI-DI
    00690103217360
    PMA / PMN Number
    K200258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THIS REPORT IS ONGOING.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO RECEIPT OF THE DEVICE AND PRODUCT EVALUATION FINDINGS. SECTIONS B4, G3, G6, H2, H3, H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS, H10, AND H11 HAS BEEN UPDATED. THE DEVICE WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. A VISUAL EXAMINATION OF THE RETURNED DEVICE SHOWED CURVATURE ALONG THE SHEATH SHAFT, LIKELY RELATED TO PACKAGING, AS WELL AS A KINK LOCATED APPROXIMATELY 6.75 INCHES FROM THE COMNUT. THE LINER WAS FULLY EXPANDED AS DESIGNED. THE DISTAL TIP DISPLAYED A RADIAL TEAR ALONG THE LINER EDGE WITH ASSOCIATED SOFT TIP DAMAGE, AND HDPE STRETCHING WAS NOTED BOTH ALONG THE RADIAL TEAR AND NEAR THE AXIAL OPENING. ALL SCORE LINES WERE INTACT. ADDITIONAL FINDINGS INCLUDED A DISTAL TIP SPLIT AND SCRATCHES ALONG THE DISTAL SHAFT. DUE TO THE NATURE OF THE COMPLAINT, NO FUNCTIONAL OR DIMENSIONAL TESTING WAS PERFORMED. THE COMPLAINTS WERE CONFIRMED THROUGH VISUAL EXAMINATION. THE COMPLAINT FOR SHEATH DISTAL TIP TORN WAS CONFIRMED THROUGH RETURNED PRODUCT EVALUATION. SHEATH DISTAL TIP TEARS MAY RESULT FROM A COMBINATION OF MULTIPLE CONTRIBUTING FACTORS. THE TIP EXPANSION MECHANISM MAY BE INFLUENCED BY INHERENT VARIATION IN THE TIP SCORING PROCESS, AND/OR BY MANUFACTURING PROCESS VARIATION DURING THE TRIMMING STEP LEADING TO HDPE DAMAGE. ADDITIONALLY, PATIENT OR PROCEDURAL FACTORS - SUCH AS CHALLENGING ANATOMY OR NON-COAXIAL ADVANCEMENT ANGLES (PATIENT HAD "MODERATE TO SEVERE TORTUOSITY") - MAY EXACERBATE INTERFERENCE BETWEEN THE VALVE AND DISTAL TIP, LEADING TO INCREASED RESISTANCE AND POTENTIAL TEARING DURING SYSTEM ADVANCEMENT. HIGH PUSH FORCES APPLIED TO OVERCOME RESISTANCE DURING SYSTEM ADVANCEMENT CAN FURTHER CONTRIBUTE TO TIP TEARING AND SUBJECT IT TOWARDS SEPARATION. WHILE MULTIPLE CONTRIBUTING FACTORS HAVE BEEN IDENTIFIED, A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. THE COMPLAINT FOR SHEATH DISTAL TIP SPLIT WAS CONFIRMED THROUGH RETURNED PRODUCT EVALUATION. THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. FURTHERMORE, THERE WAS NO REPORT OF ANY ISSUES WITH THE SHEATH DURING DEVICE UNPACKING OR PREPARATION. PER DEVICE EVALUATION, A SHEATH DISTAL TIP SPLIT WAS OBSERVED. PER INFORMATION PROVIDED, THERE WAS PRESENCE OF "MILD CALCIFICATION AND MODERATE TO SEVERE TORTUOSITY" IN THE PATIENT'S ACCESS VESSEL. CALCIFICATION AND TORTUOSITY CAN SUBJECT THE SHEATH TO SUBOPTIMAL ANGLES DURING INSERTION, ADVANCEMENT, AND/OR WITHDRAWAL THAT CAN LEAD TO NON-COAXIAL ALIGNMENT AND INCREASE INTERACTIONS BETWEEN THE DEVICES AND ACCESS VESSEL, POTENTIALLY LEADING TO THE OBSERVED SPLIT TIP. IN ADDITION, SHARP NODULES OF CALCIFICATION CAN DAMAGE THE SHEATH TIP OR SHAFT THROUGH DIRECT CONTACT. EVALUATION OF THE RETURNED DEVICE REVEALED PRESENCE OF SCRATCHES ALONG THE DISTAL SHEATH SHAFT, INDICATIVE OF PRESENCE OF CALCIFICATION. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION, TORTUOSITY) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED, AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR REPORT IS BEING SUBMITTED DUE TO CORRECTIONS AND PRE-DECONTAMINATION FINDINGS UPON RECEIPT OF THE DEVICE. INVESTIGATION IS STILL ONGOING WITH DEVICE EVALUATION. CORRECTED D8, H4, H6 IMPACT CODE, CLINICAL CODE, AND DEVICE CODE. UPDATED B4, B5, D9, G3, G6, H2, AND H11.

    Description of Event or Problem · 0

    AS REPORTED BY OUR EDWARDS LIFESCIENCES JAPAN ASSOCIATE, DURING A RIGHT TRANSFEMORAL TAVR PROCEDURE, FOLLOWING REMOVAL OF THE 14 FR ESHEATH+ AFTER DEPLOYMENT OF THE 23 MM SAPIEN 3 ULTRA RESILIA VALVE, IT WAS FOUND THAT THE TIP OF THE ESHEATH+ HAD TORN AND WAS BARELY CONNECTED BY 2-3 MM. PER FOLLOW-UP INVESTIGATION, THERE WAS NO RESISTANCE DURING INSERTION OR REMOVAL OF THE ESHEATH+ OR THE DELIVERY SYSTEM. HOWEVER, RESISTANCE WAS NOTED WHEN REMOVING THE 20 MM Z-MED BALLOON USED FOR BAV AS PRE-DILATION THROUGH THE ESHEATH+. PER THE IFU, THE COMPATIBLE SHEATH SIZE FOR A 20 MM Z-MED IS 12 FR. THERE WAS NO INJURY IN THE ACCESS VESSEL.

    Description of Event or Problem · 0

    PER PRE-DECONTAMINATION OBSERVATIONS, A SHEATH DISTAL TIP SPLIT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566752 EDWARDS ESHEATH+ INTRODUCER SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES LLC 914ESPJ 65972319 00690103217360

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female