BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3243944 · Received July 23, 2013

    Report

    Report Number
    2015691-2013-20662
    Event Type
    Death
    Date Received
    July 23, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 27, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), ARRHYTHMIAS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON VALVULOPLASTY, THE USE OF LOCAL AND/OR GENERAL ANESTHESIA, AORTIC VALVE REPLACEMENT AND THE OVERALL TAVR PROCEDURE. PULSELESS ELECTRICAL ACTIVITY (PEA) OCCURS WHEN A MAJOR CARDIOVASCULAR, RESPIRATORY, OR METABOLIC EVENT RESULTS IN THE INABILITY OF CARDIAC MUSCLE TO GENERATE SUFFICIENT FORCE IN RESPONSE TO ELECTRICAL DEPOLARIZATION. PEA IS ALWAYS CAUSED BY A PROFOUND CARDIOVASCULAR INSULT. EXAMPLES INCLUDE SEVERE PROLONGED HYPOXIA OR ACIDOSIS, EXTREME HYPOVOLEMIA, FLOW-RESTRICTING PULMONARY EMBOLUS, CARDIAC TAMPONADE, THROMBOSIS (CORONARY OR PULMONARY). IN THIS CASE, THE CAUSE FOR THE PEA CARDIAC ARREST CANNOT BE CONFIRMED. THE RECORDS DO NOT INDICATE A CONCERN ABOUT ANNULAR RUPTURE OR CARDIAC TAMPONADE THAT COULD HAVE BEEN RELATED TO THE IMPLANTATION PROCEDURE. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT¿S PULMONARY AND SYSTEMIC PRESSURES WERE UNSTABLE AFTER GENERAL ANESTHESIA INDUCTION. THE SAPIEN VALVE IMPLANTATION WAS REPORTED TO BE SUCCESSFUL WITH A WELL SEATED VALVE AND MILD-MODERATE PVL POST DEPLOYMENT. THIS PATIENT POPULATION IS TYPICALLY ELDERLY, MAY BE NON-OPERATIVE OR HIGH RISK, HAVE COMPLEX MEDICAL HISTORIES, MULTIPLE CO-MORBIDITIES, AND LOWER CARDIAC RESERVE THAT CAN LIMIT THEIR ABILITY TO RECOVER FROM PROCEDURAL INSULTS. THIS PATIENT HAD MULTIPLE SERIOUS CO-MORBIDITIES, (INCLUDING SEVERE OXYGEN DEPENDENT COPD, SEVERE PULMONARY HYPERTENSION, AND CAD). IT IS POSSIBLE THAT THE PATIENT¿S PRE-EXISTING CONDITIONS IN COMBINATION WITH PROCEDURAL FACTORS (I.E. ANESTHESIA, MEDICATIONS) AND OTHER COMPLICATIONS MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEMISE. 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

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES WAS NOTIFIED THROUGH THE IMPLANT PATIENT REGISTRY THAT THE PATIENT PASSED AWAY ON THE SAME DAY OF THE IMPLANTATION OF A 26MM SAPIEN VALVE. ACCORDING TO THE MEDICAL RECORDS OBTAINED THROUGH INVESTIGATION: THE PATIENT WAS DEEMED TO BE A HIGH RISK SURGICAL PATIENT GIVEN HIS FRAILTY, SEVERE COPD AND PULMONARY HYPERTENSION. AFTER INDUCTION OF GENERAL ANESTHESIA, THE PATIENT NEEDED INTERMITTENT BOLUSES OF NEO-SYNEPHRINE TO MAINTAIN ADEQUATE ARTERIAL BLOOD PRESSURE. THE PULMONARY ARTERY PRESSURE WAS ¾ OF SYSTEMIC PRESSURE DURING THE INITIAL PHASE AND THE PATIENT WAS PRONE TO HYPERTENSION. THE ECHO SHOWED MITRAL REGURGITATION AND SEVERE AORTIC STENOSIS WITH REGURGITATION. A LATERAL THORACOTOMY WAS MADE WITH EXPOSURE OF THE LV APEX. THE SAPIEN VALVE WAS PREPARED AND A SHEATH WAS INSERTED IN THE VENTRICLE. AFTER SUCCESSFUL BAV THE NATIVE VALVE WAS CROSSED WITH THE DELIVERY SYSTEM. AFTER POSITIONING THE VALVE IT WAS DEPLOYED WITH RAPID PACING AT A RATE OF 180 BPM. THE BALLOON WAS REMOVED AND TEE AND ASCENDING AORTIC ROOT ANGIOGRAM REVEALED A WELL SEATED DEVICE WITH MILD TO MODERATE PARAVALVULAR REGURGITATION. THE PA PRESSURES WENT ¿SUPRASYSTEMATIC¿ AT ONE POINT, REQUIRING THE INITIATION OF NITRIC OXIDE AND MULTIPLE DOSES OF LEVOPHED. THE PRESSURE EVENTUALLY RECOVERED. THE LV APEX WAS CLOSED WITHOUT COMPLICATION AND PROTAMINE WAS GIVEN AT THE END OF PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION WITH A PA PRESSURE OF 30/15 AND SINUS RHYTHM WITH A BUNDLE-BRANCH BLOCK THAT HE HAD HAD BEFORE. LATER THE SAME DAY WHILE IN ICU, THE PATIENT BECAME HYPOTENSIVE, BRADYCARDIC AND DEVELOPED PULSELESS ELECTRICAL ACTIVITY (PEA). CODE BLUE WAS CALLED. CPR WAS STARTED AND CONTINUED FOR APPROXIMATELY 4 MINUTES, WHEN THE PATIENT WAS NOTED TO HAVE A SYSTOLIC BLOOD PRESSURE IN THE 90¿S WITH PALPABLE PULSE. HOWEVER, SOON AFTER RECEIVING EPINEPHRINE THE PATIENT WENT BACK TO CARDIAC ARREST, AND WAS NOTED TO BE IN VENTRICULAR FIBRILLATION. AFTER DEFIBRILLATION THE PATIENT WAS NOTED TO BE IN PEA. HE REQUIRED MULTIPLE ROUNDS OF EPINEPHRINE, BICARBONATE, AND AMIODARONE. DURING THE CPR, HE WAS FOUND TO HAVE A LARGE AMOUNT OF BLOOD WITHIN THE LUMEN OF THE ENDOTRACHEAL TUBE, WHICH THE PHYSICIAN FELT WAS LIKELY A RESULT OF EITHER PULMONARY HEMORRHAGE RELATED TO CPR OR PULMONARY EDEMA. FOLLOWING APPROXIMATELY 20 MINUTES OF CPR THE PATIENT HAD A PULSE AND BLOOD PRESSURE, AND WAS PUT ON HIGH DOSE VASOPRESSOR MEDICATIONS. AN EMERGENT FIBER OPTIC BRONCHOSCOPY SHOWED THAT HE HAD BLOOD PRESENT THROUGHOUT THE TRACHEOBRONCHIAL TREE CONSISTENT WITH DIFFUSE ALVEOLAR HEMORRHAGE. AFTER PROLONGED CPR AND VERY HIGH DOSE VASOPRESSOR REQUIREMENTS WITH PROFOUND HYPOTENSION, THE PATIENT WENT BACK AGAIN INTO PEA CARDIAC ARREST AND EXPIRED DESPITE THE MULTIPLE RESCUE EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344236 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death