BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 10593528 · Received September 28, 2020

    Report

    Report Number
    2015691-2020-13755
    Event Type
    Injury
    Date Received
    September 28, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 8, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H6: EVALUATION CODES; SECTION H10: NARRATIVE TEXT. PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE IS A POTENTIAL RISK OF THE TAVR PROCEDURE. THE COMMANDER DELIVERY SYSTEM WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. WITHOUT THE DEVICE, VISUAL INSPECTION, FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED. REVIEW OF PROCEDURAL CINE VIDEOS/IMAGERY SHOWED THE BALLOON WAS FULLY INFLATED. THE BALLOON BURST OCCURRED AFTER DEPLOYMENT. THE DISTAL PORTION OF THE BALLOON BURST RADIALLY AND DURING REMOVAL, THE BALLOON MATERIAL WAS FOLDED OVER THE DISTAL TIP, NOSE TIP COMPONENT. DEVICE HISTORY REVIEW (DHR) REVIEW WAS PERFORMED FOR THE COMPONENTS MOST RELEVANT TO THE REPORTED EVENT. THE WORK ORDERS DID NOT REVEAL ANY MANUFACTURING NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LOT HISTORY REVIEW DID NOT REVEAL ANY OTHER SIMILAR COMPLAINTS. COMPLAINT HISTORY REVIEW FROM (B)(6) 2019 TO (B)(6) 2020 FOR THE COMMANDER DELIVERY SYSTEM (ALL MODELS AND SIZES) REVEALED OTHER SIMILAR COMPLAINTS. NO LABELING/IFU INADEQUACIES OR MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING THE INVESTIGATIONS. AVAILABLE INFORMATION SUGGESTS PATIENT FACTORS AND/OR PROCEDURAL FACTORS LIKELY CONTRIBUTED TO THE REPORTED COMPLAINT EVENTS. PER THE IFU AND TRAINING MANUALS, IF A BALLOON BURST OCCURS, ATTEMPT TO VISUALIZE LOCATION OF TEAR EITHER IN TEE OR VIA ANGIO THROUGH THE PIGTAIL OR CATHETER/DELIVERY SYSTEM. WHEN REMOVING, ENSURE THE CATHETER/DELIVERY SYSTEM AND WIRE ARE COAXIAL WITH THE SHEATH TIP. WATCH UNDER FLUORO WITH EVERY MOVEMENT. BE PATIENT AND PULL GENTLY ESPECIALLY NEAR TEAR AND BALLOON SHOULDER TRANSITIONS. DO NOT FORCE IF RESISTANCE IS MET NEAR OR AT THE SHEATH TIP. FORCE COULD RESULT IN ADDITIONAL TEARING OF THE BALLOON MATERIAL AND THE BALLOON MATERIAL OR TIP COMING OFF. IF GETTING RESISTANCE, GOING IN WITH A SNARE AND COMPRESSING THE DISTAL END OF THE TORN BALLOON TO PREVENT IT FROM ¿UMBRELLA-ING¿ AT THE TIP OF THE SHEATH COULD HELP. UNDERSTANDING WHERE THE TEAR IS MAY HELP IN THIS CASE. IF SUCCESSFUL IN PULLING THE ENTIRE BALLOON INTO THE TIP OF THE SHEATH, WITHDRAW THE CATHETER/DELIVERY SYSTEM AND SHEATH AS A SINGLE UNIT COMPLETELY FROM THE ARTERIOTOMY WHILE MAINTAINING GUIDEWIRE POSITION.DO NOT ATTEMPT TO PULL JUST THE CATHETER/DELIVERY SYSTEM THROUGH THE SHEATH. IF YOU ARE NOT ABLE TO PULL THE ENTIRE BALLOON INTO THE SHEATH, DO NOT ATTEMPT TO REMOVE THE EXPOSED BALLOON THROUGH THE VASCULATURE. RISK OF MAJOR COMPLICATION IS TOO HIGH. CONVERT TO SURGERY IMMEDIATELY. IT SHOULD BE SURGICALLY REMOVED. SURGEON SHOULD BE IN A POSITION TO BE ABLE TO EVALUATE THE SITUATION BEFORE A REAL BLEEDING EMERGENCY OCCURS. NO IFU/TRAINING MANUAL DEFICIENCIES WERE FOUND. TRANSCATHETER DELIVERY BALLOON BURST COMPLAINTS HAVE BEEN PREVIOUSLY INVESTIGATED BY EDWARDS AND DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES. A DETAILED ROOT CAUSE ANALYSIS REVEALED THAT IT IS VERY UNLIKELY THAT A PRODUCT DEFECT CONTRIBUTES TO THIS TYPE OF EVENT. THERE ARE EXTENSIVE MANUFACTURING INSPECTIONS IN PLACE TO PREVENT THIS TYPE OF MALFUNCTION (VISUAL AND DIMENSIONAL INSPECTIONS, LEAK TESTING, AND FUNCTIONAL BALLOON BURST TESTING PERFORMED TO EVERY MANUFACTURED LOT). THE THV DELIVERY SYSTEM BALLOONS ARE SUBJECT TO INCREASED RISK OF BURST DUE TO CONTACT WITH A HIGHLY CALCIFIED ANNULUS. ANALYSIS REVEALED THAT THESE TYPES OF RUPTURES ARE TYPICALLY CAUSED BY PUNCTURE FROM CALCIUM ON THE NATIVE AORTIC VALVE WHEN THE INFLATED DELIVERY SYSTEM BALLOON COMES IN CONTACT WITH THE NATIVE ANNULAR CALCIFICATION AT FULL INFLATION/DEPLOYMENT. 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. IN THIS CASE, THE COMPLAINTS WERE ABLE TO BE CONFIRMED BASED ON THE REVIEW OF THE PROVIDED CASE IMAGERY. NO MANUFACTURING NONCONFORMANCE WAS IDENTIFIED DURING THE EVALUATION. A REVIEW OF THE DHR, LOT HISTORY, COMPLAINT HISTORY AND MANUFACTURING MITIGATION'S DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT. AS REPORTED, ¿DURING VALVE DEPLOYMENT, AT THE END OF THE INFLATION THE BALLOON RUPTURED.¿ AS PER THE COMPLAINT NOTES, ¿SEVERE CALCIFICATION AT THE ANNULAR LEVEL AND EXTENDING INTO THE LVOT.¿ THE PRESENCE OF CALCIFICATION CAN CREATE A CHALLENGING ANATOMY FOR BALLOON INFLATION. WHILE THE BALLOONS ARE SUFFICIENTLY DESIGNED AND TESTED FOR RATED BURST PRESSURES WELL ABOVE THEIR INFLATION PRESSURE, CALCIFIED NODULES CAN COMPROMISE THE STRUCTURE OF THE BALLOON WALL VIA FOLLOWING MECHANISMS SUCH AS PUNCTURE, LOCAL OVERSTRETCHING, OPEN CELL IMPINGEMENT, OR STRESS CONCENTRATION. PER THE COMPLAINT DESCRIPTION, ¿THE TEAM WAS UNABLE TO COMPLETELY WITHDRAW THE COMPONENTS AND THE DISTAL EDGE OF THE BALLOON BECAME LODGED IN THE LEFT CFA.¿ IT IS POSSIBLE THAT THE BALLOON BURST ALTERED THE BALLOON PROFILE, CONTRIBUTING TO THE WITHDRAWAL DIFFICULTY AS THE ALTERED BALLOON PROFILE WOULD HAVE LIKELY BECOME CAUGHT ON THE TIP OF THE SHEATH. AS THE TRAINING MANUAL STATES, ¿DO NOT USE EXCESSIVE FORCE. TAKE CARE WHEN REMOVING THE BALLOON THROUGH THE TIP OF THE SHEATH.¿ THE RECOMMENDATION TO CONVERT TO SURGERY IF UNABLE TO PULL THE ENTIRE BALLOON INTO THE SHEATH, IS ALSO DETAILED IN THE TRAINING MANUAL. TO OVERCOME WITHDRAWAL DIFFICULTY, IT IS POSSIBLE ADDITIONAL FORCE WAS APPLIED, RESULTING IN THE SEPARATION OF THE DISTAL TIP. AVAILABLE INFORMATION SUGGESTS THAT PATIENT (CALCIFICATION) AND PROCEDURAL FACTORS (WITHDRAWAL OF A BURST BALLOON/EXCESSIVE DEVICE MANIPULATION) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THIS CASE, THE REPORTED FEMORAL INJURY WAS LIKELY CAUSED BY DEVICE MANIPULATION DURING WITHDRAWAL OF THE DEVICES AND/OR PATIENT FACTORS (E.G. CALCIFICATION) OF THE ACCESS VESSEL THAT 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 ON A MONTHLY BASIS, 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 · 1

    UDI NUMBER: (B)(4). EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, DURING A TRANSFEMORAL TAVR PROCEDURE, DURING THE DEPLOYMENT OF A 23MM SAPIEN 3 ULTRA VALVE, THE COMMANDER DELIVERY SYSTEM BALLOON RUPTURED AT THE END OF THE VALVE INFLATION. 1 TO 2CC FLUID REMAINED IN THE INFLATION DEVICE. THE DELIVERY SYSTEM BALLOON WAS PULLED BACK ACROSS THE ARCH, INTO THE DESCENDING AORTA WHILE THE VALVE AND HEART ANATOMY WERE EVALUATED BY TTE. NO ISSUES WITH THE HEART OR THE IMPLANTED VALVE WERE OBSERVED. DURING THE WITHDRAW THE DELIVERY SYSTEM INTO THE SHEATH, HIGH RESISTANCE WAS ENCOUNTERED, AND THE SHEATH TIP APPEARED TO BE ¿KINKING¿. THE DECISION WAS MADE TO PULL THE DELIVERY SYSTEM AS FAR BACK AS POSSIBLE INTO THE SHEATH AND REMOVE THE DEVICES TOGETHER. THE DEVICES WERE NOT ABLE TO BE COMPLETELY WITHDRAWN AND THE DISTAL EDGE OF THE BALLOON BECAME LODGED IN THE LEFT COMMON FEMORAL ARTERY. A CUTDOWN WAS PERFORMED TO REMOVE THE DEVICES. UPON REMOVAL, THE ESHEATH TIP WAS DISTORTED, BUT INTACT. THE VESSEL WAS REPAIRED, AND THE PATIENT WAS TRANSFERRED IN STABLE CONDITION. THE VALVE REMAINS IMPLANTED IN THE PATIENT. SEVERE CALCIFICATION AT THE ANNULAR LEVEL EXTENDING INTO THE LVOT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057990 EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750CM23A 63146696

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention