BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS EXPANDABLE SHEATH INTRODUCER

    MDR report key: 7366416 · Received March 23, 2018

    Report

    Report Number
    2015691-2018-01056
    Event Type
    Injury
    Date Received
    March 23, 2018
    Date of Event
    February 6, 2018
    Report Date
    March 5, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REF. RELATED MFGR. REPORT NUMBER: 2015691-2018-00624.

    Additional Manufacturer Narrative · 0

    IMAGES OF THE PATIENT¿S ANATOMY WERE PROVIDED, REVEALING THAT THE PATIENT HAD CALCIFIED AND TORTUOUS VESSELS ALONG WITH ANNULAR/LEAFLET CALCIFICATION.   THE ESHEATH WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. UPON VISUAL INSPECTION IT WAS OBSERVED THAT THERE WAS LINER DELAMINATION APPROXIMATELY 5¿ IN LENGTH FROM THE DISTAL TIP. MINOR DISTAL TIP DAMAGE WAS PRESENT BUT THE MARKER BAND WAS STILL INTACT. THE SHEATH SHAFT APPEARED TO BE KINKED APPROXIMATELY 4¿ AND 5¿ FROM THE DISTAL TIP. DUE TO THE NATURE OF THE COMPLAINT, NO RELEVANT DIMENSIONAL INSPECTION COULD BE PERFORMED. NO APPLICABLE FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE (SHEATH SHAFT KINK/LINER FULLY EXPANDED AND PARTIALLY DELAMINATED).   A DHR REVIEW WAS PERFORMED AND DID NOT REVEAL AND MANUFACTURING RELATED ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED NO OTHER COMPLAINTS RELATING TO ¿SHEATH DISTAL TIP ¿ LINER DELAMINATION¿ OR ¿SHEATH SHAFT ¿ KINKED, BENT¿. A REVIEW OF COMPLAINT HISTORY REVEALED THAT THE OCCURRENCE RATE DID NOT EXCEED THE FEBRUARY 2018 CONTROL LIMITS FOR THE TREND CATEGORIES OF ¿LINER DELAMINATION¿ AND ¿KINKED, BENT¿. NO IFU/TRAINING DEFICIENCIES WERE IDENTIFIED. INSPECTIONS DURING THE MANUFACTURING PROCESS SUPPORT THAT IS UNLIKELY A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT EVENTS.   THE COMPLAINTS FOR ¿SHEATH DISTAL TIP ¿ LINER DELAMINATION¿ AND ¿SHEATH SHAFT ¿ KINKED, BENT¿ ARE CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED DEVICE. PER THE COMPLAINT DESCRIPTION, THE SHEATH BECAME DAMAGED DURING REMOVAL OF THE DELIVERY SYSTEM. IT IS LIKELY THAT THE FLARED BALLOON WINGS CAUGHT ONTO THE SHEATH DISTAL TIP AT THIS PART OF THE PROCEDURE. AS SUCH, EXCESSIVE FORCE AND MANEUVERING MAY HAVE BEEN USED DURING DELIVERY SYSTEM RETRIEVAL. THE NOSE TIP/BALLOON SEPARATION FURTHER INDICATES THAT EXCESSIVE FORCE WAS LIKELY USED. IT IS LIKELY THAT THE ADDITIONAL FORCE USED DURING THE RETRIEVAL OF THE DELIVERY SYSTEM MAY HAVE RESULTED IN THE LINER DELAMINATION AND THE SHEATH SHAFT KINK. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (RETRIEVAL OF TORN BALLOON) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS.  A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. SINCE NO MANUFACTURING NON-CONFORMANCES OR IFU/TRAINING DEFICIENCIES WERE IDENTIFIED, NO CORRECTIVE/PREVENTATIVE ACTIONS ARE REQUIRED. ALSO, SINCE NO PRODUCT NON-CONFORMANCE WAS CONFIRMED IN THE RETURNED COMPLAINT SAMPLE AND THE OCCURRENCE RATES DO NOT EXCEED THE COMPLAINT CONTROL LIMITS, A PRODUCT RISK ASSESSMENT (PRA) IS NOT REQUIRED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO EDWARDS FOR EVALUATION. INVESTIGATION IS ONGOING PENDING ENGINEERING EVALUATION OF THE DEVICE.

    Description of Event or Problem · 1

    AS REPORTED, DURING A TRANSFEMORAL TAVR PROCEDURE IN THE AORTIC POSITION, DURING VALVE DEPLOYMENT, THE OPERATOR FAILED TO PULL BACK THE PUSHER AND THE DELIVERY SYSTEM BALLOON RUPTURED. UPON REMOVAL OF THE DELIVERY SYSTEM THROUGH THE EXPANDABLE SHEATH (ESHEATH), THE ESHEATH BECAME ¿DAMAGED¿ AND A DISSECTION OF THE RIGHT EXTERNAL ILIAC INTO THE COMMON FEMORAL ILIAC OCCURRED. ONCE THE VESSEL WAS SURGICALLY REPAIRED, THE VALVE WAS RETRIEVED FROM THE LVOT AND WAS SUCCESSFULLY PLACED IN THE ANNULUS. DURING DEPLOYMENT, THE PUSHER WAS NOT PULLED BACK AND IN THE FORCE TO TRY TO GET THE BALLOON UP, THE BALLOON RUPTURED. THE VALVE WAS OBSERVED TO BE SITTING IN THE ANNULUS BUT WAS HALF DEPLOYED. AN ATTEMPT WAS MADE TO REMOVE THE SYSTEM DUE TO THE BALLOON RUPTURE, HOWEVER, UPON REMOVAL A DISSECTION OCCURRED OF THE RIGHT EXTERNAL ILIAC INTO THE COMMON FEMORAL. THE ESHEATH WAS OBSERVED TO HAVE SPLIT APART AT THE LINER AND BLUE PORTION OF THE TIP, WHERE THE FIRST 1/3 OF THE ESHEATH WAS "FLAPPING BACK". A LARGE CUTDOWN WAS DONE AND THE ARTERY WAS REPAIRED. ALL BALLOON FRAGMENTS WERE REMOVED. ONCE THE VESSEL WAS REPAIRED AND THE PATIENT WAS IN STABLE CONDITION, THE LEFT SIDE WAS ACCESSED AND THE VALVE WAS ASSESSED AS IT REMAINED IN THE LVOT (WIRE ACCESS HAD BEEN LOST WHEN THE ESHEATH WAS PULLED OUT AND AS THE PHYSICIAN ATTEMPTED TO REWIRE AND PASS THROUGH THE VALVE, THE VALVE WAS PUSHED TO THE LEFT VENTRICLE). WHEN ATTEMPTING TO CROSS THE VALVE, THE VALVE EMBOLIZED INTO THE LEFT VENTRICLE. A SNARE WAS FIRST USED TO PULL THE VALVE BACK INTO PLACE BUT THE EFFORT WAS UNSUCCESSFUL. THE PHYSICIAN THEN CROSSED THE VALVE WHILE IT WAS IN THE LEFT VENTRICLE USING THE SNARE TO STEADY THE VALVE. A 26 MM Z-MED BALLOON AND A SNARE WERE THEN USED TO PULL THE VALVE BACK INTO PLACE INTO A 70:30 AORTIC POSITION. SINCE A 26 MM Z-MED BALLOON WAS USED ON A 29 MM SAPIEN 3 VALVE, THE VALVE HAD TO BE POST DILATED TO ENSURE IT WAS FULLY EXPANDED. POST OP ECHO SHOWED TRACE PVL. THE PATIENT LEFT IN STABLE CONDITION. POD1 THE PATIENT WAS REPORTED TO BE STABLE, DOING WELL, AND NEUROLOGICALLY INTACT. UPON INITIAL VISUAL INSPECTION OF THE RETURNED ESHEATH, THE LINER WAS OBSERVED TO HAVE DELAMINATED APPROX. 5" IN LENGTH FROM THE SHEATH DISTAL TIP. ADDITIONALLY, IT WAS OBSERVED THAT THE MARKER BAND WAS INTACT, THE ESHEATH HAD MINOR DISTAL DAMAGE AND THE SHEATH SHAFT HAD A KINK APPROXIMATELY 4¿ AND 5¿ FROM THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208655 EDWARDS EXPANDABLE SHEATH INTRODUCER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 916ESA 61173297

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention