BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER

    MDR report key: 6089841 · Received November 9, 2016

    Report

    Report Number
    2015691-2016-03318
    Event Type
    Death
    Date Received
    November 9, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THV/TVT REGISTRY (B)(4) PER THE INSTRUCTIONS FOR USE, VALVE EMBOLIZATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMALLY OR BULKY/SEVERELY CALCIFIED AORTIC LEAFLETS, PRESERVED EJECTION FRACTION, LOSS OF PACING CAPTURE, RAPID DEPLOYMENT, RELEASE OF STORED TENSION DURING DEPLOYMENT, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY AS THE PRIMARY METHOD OF VISUALIZATION FOR POSITIONING AND DEPLOYMENT. IN PATIENTS WITH HIGH-RISK ANATOMICAL FEATURES FOR AORTIC EMBOLIZATION (I.E. MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT ADDITIONALLY, CARDIOVASCULAR COMPLICATIONS, INCLUDING PERFORATION OR DISSECTION OF VESSELS WHICH MAY REQUIRE INTERVENTION, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THERE MAY BE CASES IN WHICH THE VALVE IS NOT ABLE TO BE DEPLOYED AT THE INTENDED LOCATION FOR VARIOUS REASONS. THIS MAY REQUIRE DEPLOYING THE VALVE AT A NON-TARGET LOCATION, TYPICALLY IN THE DESCENDING AORTA. ALTHOUGH, GENERALLY WELL TOLERATED, THE LONG TERM EFFECTS ARE NOT COMPLETELY UNDERSTOOD. NO DEVICE MALFUNCTION WAS IDENTIFIED IN THE REPORT. IN THIS CASE, THE LOSS OF CAPTURE OF THE TEMPORARY PACEMAKER LED TO A CHAIN REACTION OF EVENTS: THE VALVE EMBOLIZED UPWARD TO THE ASCENDING AORTA DURING DEPLOYMENT WHEN PACING CAPTURE WAS LOST. THE CAUSE OF THE AORTIC DISSECTION IS LIKELY RELATED TO THE PROCESS OF RELOCATING THE EMBOLIZED VALVE FROM THE ASCENDING AORTA TO THE ABDOMINAL AORTA. THE CAUSE OF THE MIGRATION OF THE VALVE IN THE ABDOMINAL AORTA, OCCLUDING THE RENAL AND ILIAC ARTERIES IS POSSIBLY RELATED TO THE LACK OF CALCIUM PRESENT WHICH SERVES AS AN ANCHORING POINT FOR THE VALVE TO SECURE ITSELF. 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. THERE IS NO ALLEGATION OR INDICATION OF A DEVICE MALFUNCTION. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE CLINICAL SPECIALIST, DURING A TF TAVR CASE, DURING VALVE DEPLOYMENT, THE TEMPORARY PACEMAKER LOST CAPTURE RESULTING IN THE VALVE LANDING IN THE ASCENDING AORTA. INITIALLY THE PATIENT REMAINED STABLE. THE COMMANDER DELIVERY SYSTEM WAS RE-ADVANCED TO RELOCATE THE VALVE IN THE ABDOMINAL AO (ABOVE THE RENALS). A SECOND VALVE AND DELIVERY SYSTEM WERE OPENED, PREPPED AND INSERTED THROUGH THE ESHEATH. AFTER VALVE ALIGNMENT, BEFORE ADVANCING THE VALVE AND DELIVERY SYSTEM AROUND THE AORTIC ARCH, AN ATTEMPT WAS MADE TO RE-ADVANCE THE PIGTAIL CATHETER INTO THE RIGHT CORONARY CUSP. DIFFICULTY WAS NOTED AND SEVERAL ATTEMPTS WERE MADE TO REPOSITION THE CATHETER, WITH AND WITHOUT A WIRE. AN ANGIOGRAM WAS PERFORMED WHICH REVEALED AN AORTIC DISSECTION. AT THIS TIME THE PATIENT BECAME INCREASINGLY UNSTABLE AND WAS EMERGENTLY INTUBATED. AS THE BP CONTINUED TO DROP, CPR WAS INITIATED. THE SECOND VALVE AND DELIVERY SYSTEM WERE REMOVED (NOT DEPLOYED). ECHO IMAGES SUGGESTED AN AORTIC INJURY AND THE CASE WAS CONVERTED TO OPEN REPAIR OF THE ASCENDING AORTA AND SURGICAL VALVE IMPLANTATION. THE PATIENT RECEIVED A 27MM MAGNA VALVE (EDWARDS) AND STENT GRAPHS TO REPAIR THE AORTA. THE PATIENT WAS EVENTUALLY TRANSFERRED TO THE CVICU UNIT IN CRITICAL BUT STABLE CONDITION. SEVEN HOURS POST-SURGERY THE PATIENT RETURNED TO THE OR BECAUSE THE VALVE DEPLOYED IN THE ABDOMINAL AORTA MOVED AND OCCLUDED THE RENAL ARTERIES AND ILIAC ARTERIES. THE AREA WAS STABILIZED VIA A STENT GRAPH. THE PATIENT REMAINED IN CRITICAL CONDITION HOWEVER LATER PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739790 EDWARDS SAPIEN 3 TRANSCATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX29A 5098970

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| R