BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3040903 · Received April 8, 2013

    Report

    Report Number
    2015691-2013-19759
    Event Type
    Death
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CINE AND TEE IMAGES WERE SUBMITTED FOR REVIEW OBSERVATIONS/IMPRESSION: OBSERVATIONS: CINE - BULKY AORTIC VALVE CALCIFICATION, MILD AORTIC ROOT CALCIFICATION, NO PORCELAIN AORTA, NO MAC - STABLE BAV X1 DEMONSTRATED - FAIR COAXIAL ALIGNMENT WITH LATERAL BIAS OF THE DELIVERY SYSTEM AND VALVE - GOOD IMAGE INTENSIFIER ANGLE (IIA) - POSITIONING 67:33 VENTRICULAR ON THE LATERAL EDGE AND 75:25 VENTRICULAR MEDIALLY. DURING DEPLOYMENT THERE IS NO NOTICEABLE MOVEMENT - NO LOSS OF PACING CAPTURE AND VENTILATION WAS HELD. NEXT CINE IMAGE DEMONSTRATES A VALVE IN THE VENTRICLE AND A 2ND VALVE BEING POSITIONED IN THE NATIVE ANNULUS. THE 2ND SAPIEN VALVE IS POSITIONED 67:33 AORTIC AND IS NOT NOTED TO BE TILTED. DURING DEPLOYMENT THE VALVE DOES NOT MOVE. TEE - NO OBLITERATION OF SOV - BULKY CALCIFICATION - ON REVIEW OF TEE THERE APPEARS TO BE A VALVE POSITIONED TOO VENTRICULAR (IN LVOT); NO SIGNIFICANT PVL BUT PERHAPS WIRE INDUCED TRANSVALVULAR AI IMPRESSIONS: FAIR COAXIAL ALIGNMENT AND POSITIONING THAT WAS TOO VENTRICULAR LEAD TO CANTED VALVE POSITIONING, AND PREDISPOSED TO LV EMBOLIZATION. THE 2ND SAPIEN VALVE WAS POSITIONED AND DEPLOYED SUCCESSFULLY. NO IMAGING AVAILABLE DEMONSTRATING THE VALVES BEING ENTANGLED AND SUBSEQUENT EMBOLIZATION INTO THE AORTA. PER THE SAPIEN VALVE INSTRUCTIONS FOR USE (IFU) AND THE THV TRAINING GUIDE, VALVE MALPOSITION, AND EMBOLIZATION ARE KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THV POSITIONED TOO VENTRICULAR IS ALSO ONE OF THE KNOWN REASONS FOR EMBOLIZATION OF THE DEVICE. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES 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. IN THIS CASE, THE INFORMATION AVAILABLE AND IMAGING REVIEW RESULTS INDICATE A COMBINATION OF PATIENT AND PROCEDURAL FACTORS LIKELY CAUSED OR CONTRIBUTED TO THESE EVENTS. THERE WAS NO IMAGING AVAILABLE DEMONSTRATING THE VALVES BEING ENTANGLED AND SUBSEQUENT EMBOLIZATION INTO THE AORTA. LAST, PER MEDICAL RECORDS RECEIVED, THE PATIENT'S DEATH WAS ATTRIBUTED TO EXCESSIVE BLEEDING; POSSIBLY SECONDARY TO PATIENT'S HISTORY OF HEPARIN INDUCED THROMBOCYTOPENIA. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED. THERE WERE THREE MDR REPORTS SUBMITTED FOR THIS CASE, PLEASE REFERENCE MANUFACTURER REPORTS NO./AND RELATED COMPLAINTS: 2015691-2013-19760 ((B)(4) - 2ND VALVE) AND 2015691-2013-19762 ((B)(4) - RF3 SHEATH).

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS ONGOING. THIS IS THE FIRST REPORT (1 OF 3) BEING SUBMITTED FOR THIS EVENT. THIS REPORT IS FOR THE FIRST VALVE.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, DURING THE TRANSFEMORAL TAVR PROCEDURE, THE 23MM SAPIEN VALVE WAS DEPLOYED CANTED IN A TOO VENTRICULAR POSITION CAUSING AORTIC INSUFFICIENCY AND EMBOLIZATION OF THE VALVE INTO THE VENTRICLE. A SECOND VALVE WAS DEPLOYED; HOWEVER; WHILE ATTEMPTING TO REMOVE THE FIRST VALVE FROM THE VENTRICLE, THE SECOND VALVE BECAME ENTANGLED CAUSING BOTH VALVES TO EMBOLIZE INTO THE ASCENDING AORTA. THE PATIENT WAS CONVERTED TO OPEN HEART SURGERY, BOTH SAPIEN VALVES WERE RETRIEVED AND A 21MM MAGNA EASE VALVE WAS IMPLANTED. THIS PATIENT EXPIRED ONE DAY POST TAVR PROCEDURE FROM UNCONTROLLED EXCESSIVE BLEEDING. THIS REPORT IS FOR THE FIRST VALVE. PER REPORT, DYNACT WAS USED TO DETERMINE THE BEST ANGLE FOR THE IMAGE INTENSIFIER AND "IT APPEARED THAT POSITIONING WAS OPTIMAL"; HOWEVER, "AS DEPLOYMENT OCCURRED, THERE APPEARED TO BE DISPLACEMENT INFERIORLY AND OBVIOUSLY A LOW DELIVERY OF THE PROSTHESIS." ECHO AND ANGIOGRAPHIC IMAGING CONFIRMED THE VALVE DEPLOYED IN A 20:80 VENTRICULAR POSITION. THE PATIENT REMAINED STABLE AND THE DECISION WAS MADE TO DEPLOY A SECOND VALVE. BEFORE POSITIONING THE SECOND VALVE THE MEIER WIRE HAD TO BE ADJUSTED. AS THE SECOND VALVE WAS BEING POSITIONED, THE FIRST VALVE DISLODGED INTO THE VENTRICLE. THE SECOND VALVE WAS DEPLOYED IN A 50:50 POSITION. WIRE POSITION WAS MAINTAINED AND THE DECISION WAS MADE TO TRY AND RETRIEVE THE FIRST VALVE VIA A VENTRICULOTOMY. ONCE ACCESS WAS GAINED TO THE LEFT VENTRICLE VIA LEFT THORACOTOMY, PURSE STRING SUTURES WERE PLACED AND AN INCISION WAS PLACED AT THE APEX OF THE LEFT VENTRICLE. A PAIR OF FORCEPS WAS INSERTED TO CRUSH AND RETRIEVE THE FIRST VALVE. HOWEVER IT WAS NOTICED DURING RETRIEVAL THAT THE TWO VALVES WERE ENTANGLED AND AS A RESULT BOTH WERE DISLODGED AND EJECTED INTO THE ASCENDING AORTA. AT THIS POINT, THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS AND CONVERTED TO AN OPEN REPAIR. EKG CHANGES WERE CONSISTENT WITH OBSTRUCTION TO CORONARY FLOW. BOTH VALVES WERE RETRIEVED FROM THE AORTA AND A 21MM EDWARDS MAGNA EASE SURGICAL VALVE WAS SUTURED IN PLACE. THE PATIENT REMAINED STABLE DURING THE PROCEDURE, WAS WEANED OFF BYPASS AND TRANSFERRED TO THE ICU. ADDITIONAL INFORMATION RECEIVED BY THE CS INDICATES THE PATIENT EXPIRED SOMETIME AFTER THE TAVR PROCEDURE FROM UNCONTROLLED BLEEDING. DUE TO A HISTORY OF HEPARIN INDUCED THROMBOCYTOPENIA, ANTICOAGULATION FOR THE PROCEDURE WAS ACHIEVED WITH ANGIOMAX. PER THE MEDICAL RECORDS, THE PATIENT HAD SIGNIFICANT BLEEDING AND WAS HEMODYNAMICALLY UNSTABLE POST-OPERATIVELY. HIS HEMOGLOBIN DROPPED TO 4.1 POSTOPERATIVELY FROM 15 PRE-OPERATIVELY; THE PATIENT'S HEMOGLOBIN WAS AS LOW AS 2. THE PATIENT REMAINED ON VENTILATOR SUPPORT AND ON MULTIPLE PRESSORS WITH PERSISTENT HYPOTENSION AND ON POST OP DAY 1, HE LOST PULSES AND A CODE BLUE WAS CALLED. HIS CHEST WAS RE-OPENED AND HE WAS FOUND TO BE EXTREMELY HYPOVOLEMIC BUT THERE WAS NO TAMPONADE PRESENT. THERE WAS ONLY A SMALL AMOUNT OF CLOT IN THE MEDIASTINUM. BOTH THE CHEST TUBE AND THE MEDIASTINAL TUBE APPEARED TO BE DRAINING AND HAD DRAINED OVER 2 LITERS OF BLOOD EACH. LIFE SAVING MEASURES WERE PERFORMED, HOWEVER, THE PATIENT EXPIRED. ADDITIONAL INFORMATION: THERE WAS MILD VENTRICULAR SEPTAL HYPERTROPHY. THE AORTIC VALVE/ROOT CALCIFICATION WAS DESCRIBED AS MILD TO MODERATE. THE IMAGE INTENSIFIER ANGLE WAS DESCRIBED AS GOOD. COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WAS DEEMED POOR. VENTILATION WAS HELD DURING DEPLOYMENT AND THERE WAS NO LOSS OF PACING CAPTURE LOST DURING DEPLOYMENT. THE CAUSE OF THE MALPOSITION OF THE FIRST VALVE IS NOT YET KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143633 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| R