BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRODUCER, CATHETER

    MDR report key: 19869196 · Received July 31, 2024

    Report

    Report Number
    2015691-2024-05764
    Event Type
    Death
    Date Received
    July 31, 2024
    Date of Event
    July 9, 2024
    Report Date
    April 15, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K200258
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR CORRECTION. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN UPDATED: CORRECTED H.11 NARRATIVE. SINCE NO EDWARDS PRODUCT DEFECTS OR LABELING DEFICIENCIES WERE IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTION NOR PRODUCT RISK ASSESSMENT IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR CORRECTION AND ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN UPDATED: CORRECTED H.6 INVESTIGATION CONCLUSIONS AND INVESTIGATION FINDINGS. ADDED NEW INFORMATION TO H.6 COMPONENT CODE, DEVICE CODE AND TYPE OF INVESTIGATION AND H.10 RELATED REPORT. MW5159226 WAS RECEIVED THROUGH FDA MEDWATCH PROGRAM. THE DEVICE WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION AND THE FOLLOWING WAS OBSERVED. ASSOCIATED VALVE EXPOSED THROUGH LINER PUNCTURE APPROXIMATELY 5'' FROM DISTAL TIP. LINER PUNCTURE APPROXIMATELY 4'' IN LENGTH, STARTING APPROXIMATELY 3'' FROM DISTAL STRAIN RELIEF. TWO (2) KINKS NOTED APPROXIMATELY 2.5'' FROM DISTAL TIP AND 4.25'' FROM DISTAL STRAIN RELIEF. DISTAL TIP IS UNOPENED. LINER PARTIALLY EXPANDED APPROXIMATELY 3.5'' FROM DISTAL STRAIN RELIEF, REST OF LINER IS UNEXPANDED. STRAIN RELIEF TEARS APPROXIMATELY 1'' AND 1.5'' FROM COMNUT. LINER STRETCHING ON UNEXPANDED PORTION OF THE LINER, APPROXIMATELY 5.5'' IN LENGTH, STARTING FROM 2'' FROM DISTAL TIP. SCRATCHES NOTED ON THE DISTAL END OF THE SHEATH SHAFT. IMAGERY WAS PROVIDED FROM THE SITE AND REVEALED THE FOLLOWING: ASSOCIATED CRIMPED VALVE IS ON THE DELIVERY SYSTEM AND EXPOSED THROUGH THE LINER PUNCTURE. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION WAS PERFORMED, AND NO EVIDENCE OF PRODUCT NON-CONFORMANCES OR LABELING/IFU INADEQUACIES WERE IDENTIFIED IN THE EVALUATION. THE COMPLAINTS ARE CONFIRMED BASED ON THE EVALUATION OF THE RETURNED DEVICE. HOWEVER, NO MANUFACTURING NONCONFORMANCE WAS IDENTIFIED DURING EVALUATION. AS THE LOT NUMBER IS UNKNOWN, A REVIEW OF THE DHR AND LOT HISTORY WAS UNABLE TO BE PERFORMED. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. FURTHERMORE, NO ABNORMALITIES WERE REPORTED DURING DEVICE UNPACKING OR PREPARATION. AS REPORTED, ''IT WAS A CASE OF A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. HIGH PUSH FORCE WAS EXPERIENCED WHEN ADVANCING THE DELIVERY SYSTEM WITH VALVE INTO THE ESHEATH. WHEN THE OPERATOR PANNED DOWN TO LOOK AT THE SHEATH, IT WAS NOTED THAT THE DELIVERY SYSTEM AND VALVE HAD PERFORATED THE ESHEATH AND APPEARED TO HAVE PERFORATED THE AORTA.'' PER ADDITIONAL INFORMATION, IT IS UNKNOWN IF THE SYSTEM WAS INSERTED AT A STEEP ANGLE AND THE EXACT MEASUREMENTS AND CONDITION OF THE PATIENT'S ACCESS VESSEL ARE UNKNOWN. PER DEVICE EVALUATION, THE ASSOCIATED VALVE WAS OBSERVED TO BE EXPOSED THROUGH THE LINER PUNCTURE. ADDITIONALLY, TWO (2) KINKS WERE NOTED ON THE SHEATH SHAFT AND LINER STRETCHING WAS NOTED ALONG THE LINER PUNCTURE. VARIATION IN THE SEAM FORMING PROCESS MAY CONTRIBUTE TO THE LINER NOT EXPANDING. PER THE MANUFACTURING ACCEPTANCE CRITERIA, A LINER THAT IS STRETCHING OR DOES NOT OPEN IN THE PROXIMAL AND MIDDLE REGION OF THE SHEATH SHAFT, IS ACCEPTABLE AS LONG AS THE DISTAL 2'' SEGMENT OF THE SHEATH IS OPEN AFTER FULL EXPANSION OF THE DEVICE (AND CALCULATED PUSH FORCE OF TESTED UNITS MEET SPECIFICATION). THIS FAILURE MODE OCCURS WHEN THE HDPE OUTER LAYER ADHERES TO THE ETCHED PTFE LINER, RESULTING IN THE SEAM TO STRETCH, BUT HAS NO IMPACT TO THE FORM, FIT, OR FUNCTION OF THE ESHEATH. PER FUNCTIONAL TESTING, THE REST OF THE LINER EXPANDED AS DESIGNED AND THE TIP OPENED AS DESIGNED. THEREFORE, THE DEVICE MEETS THE ACCEPTANCE CRITERIA. ADDITIONALLY, THE PRESENCE OF SEVERAL PATIENT/PROCEDURAL FACTORS MAY CONTRIBUTE TO IMPROPER LINER EXPANSION, SUCH AS ACCESS VESSEL CALCIFICATION, INADEQUATE MINIMUM LUMINAL DIAMETER OF ACCESS VESSELS, THV CRIMP PROFILE, AND INADEQUATE FLUSHING OF DEVICES DURING PREPARATION. PER THE TRAINING MANUAL, ''PUSH FORCE CAN VARY DUE TO ANGLE OF ACCESS AND INSERTION, THV SIZE, VESSEL DIAMETER, TORTUOSITY AND DEGREE OF CALCIFICATION. FOLLOWING PROPER VALVE CRIMPING TECHNIQUE AND ENSURE VALVE IS DELIVERED AS STRAIGHT AS POSSIBLE.'' IF THE DELIVERY SYSTEM AND VALVE WERE INSERTED THROUGH THE SHEATH AT A STEEP ANGLE, IT CAN RESULT IN NON-COAXIAL ALIGNMENT BETWEEN THE DELIVERY SYSTEM AND SHEATH. NON-COAXIAL ADVANCEMENT OF THE DELIVERY SYSTEM THROUGH THE SHEATH MAY LEAD TO RESISTANCE. ADDITIONALLY, IF ACCESS VESSEL CALCIFICATION WAS PRESENT, IT CAN REDUCE THE VESSEL LUMEN DIAMETER AND INCREASE RESTRICTION LEADING TO RESISTANCE. CALCIFICATION CAN ALSO RESULT IN THE CREATION OF SUB-OPTIMAL ANGLES DURING DELIVERY SYSTEM INSERTION THAT MAY LEAD TO RESISTANCE. HOWEVER, NO INFORMATION REGARDING INSERTION ANGLE AND DEGREE OF ACCESS VESSEL CALCIFICATION WERE PROVIDED. IT IS POSSIBLE THAT ADDITIONAL DEVICE MANIPULATION TO OVERCOME THE RESISTANCE MAY BE APPLIED DURING THE PROCEDURE RESULTING IN THE REPORTED LINER PUNCTURE. DURING DELIVERY SYSTEM ADVANCEMENT THROUGH A CHALLENGING PATHWAY, IT IS POSSIBLE THAT THE DEVICES MAY NOT BE COAXIALLY ALIGNED. THIS CAN LEAD TO THE CRIMPED VALVE TO CATCH ONTO THE LINER AND LEAD TO LINER PUNCTURE. ADDITIONALLY, PRA WAS PREVIOUSLY INITIATED TO DOCUMENT INVESTIGATION AND ASSESS ASSOCIATED RISKS FOR LINER TEARS THAT OCCUR WITH IMPROPER EXPANSION OF THE SHEATH. PRA STATES THAT LINER TEARS CAN OCCUR WHEN THE HDPE OUTER LAYER ADHERES TO THE ETCHED PTFE LINER, PREVENTING THE SEAM FROM OPENING. HOWEVER, THE SEQUENCE OF EVENTS AND CONTRIBUTING FACTORS WERE UNABLE TO BE DETERMINED AND A DEFINITIVE ROOT CAUSE IS UNABLE TO BE IDENTIFIED. 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 IFU/LABELING/TRAINING MANUAL INADEQUACIES WERE IDENTIFIED. A PRODUCT RISK ASSESSMENT (PRA) AND A CORRECTIVE ACTION PREVENTATIVE ACTION (CAPA) WERE PREVIOUSLY INITIATED TO CAPTURE THE INVESTIGATION OF THESE TYPE OF EVENTS AND DRIVE ANY POTENTIAL CORRECTIVE/PREVENTATIVE ACTIONS.

    Description of Event or Problem · 0

    AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), IT WAS A CASE OF A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. HIGH PUSH FORCE WAS EXPERIENCED WHEN ADVANCING THE DELIVERY SYSTEM WITH VALVE INTO THE ESHEATH. LOOKING AT THE SHEATH, IT WAS NOTED THAT THE DELIVERY SYSTEM AND VALVE HAD PERFORATED THE ESHEATH AND APPEARED TO HAVE PERFORATED THE AORTA. A CODA BALLOON WAS INSERTED, AND CPR WAS STARTED. ECMO CANNULA WAS UNABLE TO BE INSERTED. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562044 INTRODUCER, CATHETER EDWARDS ESHEATH+ INTRODUCER SET DYB EDWARDS LIFESCIENCES ESHEATH PLUS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death