BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3092166 · Received May 3, 2013

    Report

    Report Number
    2015691-2013-19986
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), PERMANENT OR TRANSIENT NEUROLOGICAL EVENTS INCLUDING STROKE ARE POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE TAVR PROCEDURE AND THE USE OF THE EDWARDS THV DEVICES. IN ADDITION, MAJOR RISK FACTORS FOR STROKE INCLUDE CAROTID DISEASE, HTN, ATRIAL FIBRILLATION, DIABETES, FAMILY HISTORY OF STROKE, HIGH CHOLESTEROL, INCREASING AGE, SMOKING, AND RACE. ALTHOUGH THE EXACT CAUSE FOR THE STROKE IN THIS CASE CANNOT BE CONFIRMED, THE TIMING OF THE EVENT SUGGESTS A RELATIONSHIP TO THE PROCEDURE. IN ADDITION, THE PATIENT'S CO-MORBIDITIES COULD HAVE PUT THE PATIENT AT RISK FOR THE EVENT. PER THE IFU, HYPOTENSION IS ANOTHER POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR PROCEDURE, INCLUDING STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY (BAV), THE USE OF ANESTHESIA, AND THE VALVE REPLACEMENT. HYPOTENSION IS EXTREMELY COMMON DURING THE TAVR PROCEDURE AND HAS MULTIPLE POTENTIAL ETIOLOGIES, INCLUDING THE EFFECTS OF ANESTHESIA AND RAPID VENTRICULAR PACING, AND IS REQUIRED DURING BAV AND SUBSEQUENT VALVE DEPLOYMENT. IN THIS CASE, THE EXACT CAUSE OF THE HYPOTENSION IS CANNOT BE CONFIRMED; HOWEVER, THE PATIENT'S UNDERLYING EF OF 25% IN COMBINATION WITH THE EFFECTS OF RAPID VENTRICULAR PACING COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. AS REPORTED, THERE WAS NO ISSUES WITH THE VALVE ITSELF. LASTLY, PER THE IFU, ARRHYTHMIAS AND CONDUCTION SYSTEM INJURIES ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE AND BIOPROSTHETIC HEART VALVES. DAMAGE TO THE MYOCARDIUM AND ITS CONDUCTION SYSTEM CAUSES ACQUIRED HEART BLOCK AND CAN RESULT IN HEART BLOCK DURING OR AFTER THE PROCEDURE. THIS TYPICALLY OCCURS IN PATIENTS WITH UNDERLYING CARDIAC DISEASE AND/OR CONDUCTION ABNORMALITIES. ACCORDING TO LITERATURE REVIEW AND THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC), THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY PROVIDE AN EXPLANATION FOR THESE COMPLICATIONS OF THE PROCEDURE. OTHER FACTORS THAT COULD CONTRIBUTE TO THE ONSET OF CONDUCTION DEFECTS INCLUDE UNDERLYING HEART DISEASE, ELECTROLYTE DISTURBANCES, AND CERTAIN MEDICATIONS (I.E. BETA-BLOCKERS, CALCIUM CHANNEL BLOCKERS). IN THIS CASE, THE EXACT CAUSE OF THE REPORTED HEART BLOCK CANNOT BE CONFIRMED. HOWEVER, IN ADDITION TO THE PROCEDURE ITSELF, THE PATIENT'S UNDERLYING HEART DISEASE MAY HAVE CONTRIBUTED TO THE 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; THEREFORE NO FURTHER ACTIONS ARE REQUIRED. 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.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSAPICAL TAVR PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND BRADYCARDIC POST DEPLOYMENT OF THE VALVE. INOTROPES AND VASOPRESSORS WERE ADMINISTERED. CPR WAS PERFORMED AND THE PATIENT WAS PACED. THE VALVE WAS ASSESSED ON ECHO. THERE WAS NO PARAVALVULAR LEAK (PVL) OR CENTRAL AORTIC INSUFFICIENCY (CAI). THE SHEATH WAS REMOVED AND 2 UNITS OF BLOOD GIVEN. EPICARDIAL PACING WIRES WERE PLACED AND THE PATIENT LEFT THE OR WITH THE PACEMAKER SET AT 100 BPM. THE DISCHARGE SUMMARY WAS LATER PROVIDED AND REVEALED THAT THE PATIENT DEVELOPED RESPIRATORY FAILURE DURING THE PROCEDURE AND REQUIRED INTUBATION. SHE DEVELOPED ALTERED MENTAL STATUS. WITH HER ALTERED MENTAL STATUS, NEUROLOGY CONSULT WAS OBTAINED AND CT HEAD WITHOUT CONTRAST SHOWED EVIDENCE OF LARGE LEFT MCA INFARCT. THE DAY AFTER THE PROCEDURE THE PATIENT DEVELOPED HEART BLOCK AND WAS BROUGHT BACK TO THE LAB FOR PERMANENT PACEMAKER PLACEMENT. THROUGHOUT THE REMAINDER OF THE HOSPITAL STAY, THE PATIENT WAS MAINTAINED IN THE ICU. SHE HAD POOR RECOVERY FROM THE LARGE STROKE. TOWARDS THE END OF HER HOSPITAL STAY THE FAMILY ELECTED FOR CONSERVATIVE MEASURES. SHE RECEIVED DIALYSIS SECONDARY TO ACUTE RENAL FAILURE IN AN EFFORT TO HELP WITH VOLUME OVERLOAD. THE PATIENT'S CONDITION WORSENED AND SHE WAS MADE DO NOT RESUSCITATE CODE STATUS. UNFORTUNATELY SHE LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194303 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention