BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 10512155 · Received September 9, 2020

    Report

    Report Number
    2015691-2020-13488
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    August 18, 2020
    Report Date
    August 18, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: SECTION F10: PATIENT CODE. ADDITIONAL INFORMATION: SECTION H10: NARRATIVE TEXT. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-13489.

    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 RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. THE SEPARATED BALLOON MATERIAL WAS RETURNED IN A SEPARATE TUBE. VISUAL INSPECTION REVEALED THE DISTAL BALLOON WAS COMPLETELY SEPARATED FROM THE DELIVERY SYSTEM. THE BALLOON WAS SEPARATED ON THE PROXIMAL SHOULDER IN 3 SMALL PIECES. SOME OF THE BALLOON MATERIAL PIECES APPEARED TO BE MISSING. A KINK ON THE GUIDE WIRE LUMEN AT THE CRIMP BALLOON AND BALLOON SHAFT BOND WAS OBSERVED. THE DISTAL NOSE TIP LEG WAS SLIGHTLY FLARED OUT. SCRATCHES WERE OBSERVED ON THE FLEX SHAFT 3.5 INCHES FROM THE HANDLE NOSE CONE. A HALF RADIAL CUT ON THE FLEX SHAFT 18 INCHES FROM THE FLEX TIP AND A KINK 1 INCH PROXIMAL TO THE CUT WERE OBSERVED. THE CUT APPEARED TO BE CREATED BY TOOLS AND WAS LIKELY DUE TO THE PHYSICIAN ATTEMPTING TO CUT THE FLEX SHAFT WITH SCISSORS AFTER THE CASE. REVIEW OF THE PROVIDED CASE IMAGERY INDICATED MULTIPLE ATTEMPTS TO WITHDRAW THE DELIVERY SYSTEM WERE PERFORMED. THE DELIVERY SYSTEM CAN BE SEEN CATCHING ON THE SHEATH DISTAL TIP DURING RETRIEVAL ATTEMPT INTO THE SHEATH. AS THE DELIVERY SYSTEM WAS STILL CAUGHT AT THE SHEATH TIP, IT IS POSSIBLE THAT AS MORE MANIPULATIONS WERE EXERTED TO PULL THE DELIVERY SYSTEM INTO THE SHEATH, THE LINER APPEARS TO BE DELAMINATED WITH THE C-MARKER BAND DETACHED AND MOVED AWAY FROM THE SHEATH DISTAL TIP. REVIEW OF THE PHOTOGRAPHS OF THE DEVICE AFTER USE REVEALED THE BALLOON WAS BURST RADIALLY, AND THE BALLOON WAS FOLDED OVER THE NOSE TIP. IT CAN ALSO BE NOTED THE DISTAL PORTION OF THE BALLOON WAS SEPARATED FROM THE REST OF THE DELIVERY SYSTEM. IN ADDITION, A PIECE OF THE BALLOON MATERIAL WAS SEPARATED FROM THE REST. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE CONDITION OF THE RETURN DEVICE. DIMENSIONAL ANALYSIS OF THE SINGLE WALL THICKNESS OF THE INFLATION BALLOON ALONG THE EDGES OF THE OBSERVED TEAR WAS PERFORMED. ALL MEASUREMENTS MET SPECIFICATION. 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 REVEALED NO OTHER SIMILAR COMPLAINTS. COMPLAINT HISTORY REVIEW FROM SEPTEMBER 2019 TO AUGUST 2020 FOR THE COMMANDER DELIVERY SYSTEM (ALL MODELS AND SIZES) REVEALED OTHER SIMILAR COMPLAINTS FOR ALL ASSOCIATED COMPLAINT CODES. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING THE EVALUATIONS. AVAILABLE INFORMATION SUGGESTS PROCEDURAL FACTORS AND/OR PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. PER THE INSTRUCTIONS FOR USE (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 AS 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 CONFIRMED BASED ON THE VISUAL INSPECTION OF THE RETURNED DEVICE. INVESTIGATION OF THE DEVICE, DHR, LOT HISTORY AND COMPLAINT HISTORY REVEALED NO INDICATION THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE EVENT. A REVIEW OF MANUFACTURING MITIGATIONS SUPPORTS THAT THE DELIVERY SYSTEM HAS PROPER INSPECTIONS IN PLACE TO DETECT ISSUES RELATED TO THE COMPLAINT EVENTS. PER THE COMPLAINT FILE, IN THIS CASE, THE PATIENT HAD CALCIFICATION PRESENT IN THE LANDING ZONE (STJ AND AORTIC LEAFLETS) AND THE BALLOON BURST AT FULL INFLATION. 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. A BALLOON BURST MAY HAVE CREATED DIFFICULTY WITHDRAWING THE DELIVERY SYSTEM INTO THE SHEATH. THE ALTERED BALLOON PROFILE WOULD HAVE LIKELY BECOME CAUGHT ON THE TIP OF THE SHEATH AND CONTRIBUTED TO RESISTANCE DURING WITHDRAWAL. AS IT CAN BE NOTED IN THE PROCEDURAL IMAGERY PROVIDED, ADDITIONAL FORCE WAS EXERTED ON THE DELIVERY SYSTEM LEADING TO THE BALLOON SEPARATING. ALTHOUGH A DEFINITE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS PATIENT FACTORS (VALVULAR CALCIFICATION) MAY HAVE CONTRIBUTED TO THE BALLOON BURST AND REPORTED WITHDRAWAL DIFFICULTIES. PROCEDURAL FACTORS (WITHDRAWAL OF A BURST BALLOON/EXCESSIVE MANIPULATION) LIKELY CONTRIBUTED TO THE BALLOON MATERIAL SEPARATION AND SUBSEQUENT SURGICAL CUTDOWN PERFORMED TO REMOVE THE SEPARATED BALLOON MATERIAL AND NOSE CONE. 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. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-13489.

    Additional Manufacturer Narrative · 1

    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. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATE IN (B)(6), A 23MM SAPIEN 3 ULTRA VALVE WAS DEPLOYED IN THE AORTIC POSITION BY THE TRANSFEMORAL APPROACH. BALLOON AORTIC VALVULOPLASTY (BAV) WAS NOT PERFORMED PRIOR TO VALVE DEPLOYMENT. DURING VALVE DEPLOYMENT, THE COMMANDER DELIVERY SYSTEM BALLOON BURST WHEN AT FULL INFLATION. DIFFICULTIES WERE ENCOUNTERED WHILE ATTEMPTING TO RETRIEVE THE DELIVERY SYSTEM AS THE DISTAL BALLOON PORTION WOULD NOT ENTER THE SHEATH. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE BALLOON USING BOTH NEGATIVE AND NEUTRAL PRESSURES, PLUS ADVANCING AND GENTLY TURNING THE DELIVERY SYSTEM WHILE WITHDRAWING INTO THE SHEATH. AS A RESULT, A SECTION OF THE BALLOON MATERIAL SEPARATED. THE DISTAL SHEATH TIP WAS ¿DEFORMED¿ AND UPON FINAL INSPECTION A LINER DELAMINATION WAS OBSERVED. ONCE THE DELIVERY SYSTEM WAS REMOVED, EFFORTS WERE MADE TO RETRIEVE THE BALLOON IN A RETROGRADE DIRECTION VIA TRACTION ON A SNARE. THE BALLOON MATERIAL CEASED TO BE MOBILE AFTER ONLY A SHORT DISTANCE AND IT APPEARED TO BE WEDGED WITHIN THE FEMORAL ARTERY. A CUTDOWN WAS PERFORMED AND APPROXIMATELY 9 CM OF THE MISSING BALLOON MATERIAL, INCLUDING THE NOSE CONE, WERE REMOVED. THE DISTAL TIP OF THE DELIVERY SYSTEM REMAINED IN THE PATIENT. AN ATTEMPT WAS MADE TO REMOVE THE REMAINING TIP WITH THE SNARE; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. AT THE TIME OF THE REPORT, THE PATIENT HAD NOT BEEN DISCHARGED. A RIGHT GROIN HEMATOMA POST REPAIR AND POSSIBLE INFECTION HAVE BEEN IDENTIFIED. INFORMATION REGARDING THE NATIVE ANNULAR DIAMETER WAS NOT PROVIDED. NO LARGE CALCIUM BURDEN ON THE ANNULUS OR NATIVE LEAFLETS WAS REPORTED. NO ACCESS VESSEL TORTUOSITY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970423 EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF23U 63009620

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention