BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 6592630 · Received May 25, 2017

    Report

    Report Number
    2015691-2017-01485
    Event Type
    Injury
    Date Received
    May 25, 2017
    Date of Event
    May 11, 2017
    Report Date
    May 11, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS UNDERWAY.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING NON-CONFORMANCE ISSUES THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. A LOT HISTORY REVIEW DID NOT REVEAL ANY OTHER COMPLAINTS RELATED TO ¿LEAFLET ¿ MOTION RESTRICTED ¿ IN PATIENT¿ OR ¿VALVE ¿ REGURGITATION-CENTRAL LEAK¿. A REVIEW OF COMPLAINT HISTORY REVEALED THAT THE OCCURRENCE RATES DID NOT EXCEED THE MAY 2017 CONTROL LIMITS FOR APPLICABLE TREND CATEGORIES ¿LEAFLET MOTION RESTRICTED (IN PATIENT)¿ AND ¿REGURGITATION¿. NO INSTRUCTIONS FOR USE (IFU OR TRAINING DEFICIENCIES WERE IDENTIFIED. MANUFACTURING INSPECTIONS SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINT. THE COMPLAINTS OF ¿LEAFLET ¿ MOTION RESTRICTED-IN PATIENT¿ AND ¿VALVE ¿ REGURGITATION-CENTRAL LEAK WERE CONFIRMED BASED ON THE REVIEW OF IMAGERY, BUT NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED. A REVIEW OF THE DHR, LOT HISTORY, AND COMPLAINT HISTORY REVEALED NO INDICATION THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT. DURING THE MANUFACTURING PROCESS, ALL SAPIEN 3 VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR PROPER COAPTATION UNDER PHYSIOLOGICAL BACKPRESSURE CONDITIONS PRIOR TO RELEASE FOR DISTRIBUTION. THEREFORE, IT IS HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION CONTRIBUTED TO THE EVENT. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER VALVE PERFORMANCE WILL BE IMPAIRED. THERE ARE SEVERAL POTENTIAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO A REPORT OF A RESTRICTED OR NONFUNCTIONING LEAFLET. BASED ON HISTORICAL REVIEW OF COMPLAINTS, THESE EVENTS ARE TYPICALLY A RESULT OF TOO VENTRICULAR DEPLOYMENT OF THE VALVE IN COMBINATION WITH NATIVE LEAFLET OVERHANG. OTHER POTENTIAL CONTRIBUTING FACTORS INCLUDE: LEAFLET IMPINGEMENT IN A HIGHLY CALCIFIED NATIVE VALVE, IMPINGEMENT OF A LEAFLET DUE TO THE GUIDE WIRE, OVER EXPANDED VALVE DUE TO IMPROPER INFLATION VOLUME, OR SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. THIS CAN RESULT IN A TEMPORARY DECREASE IN THE PRESSURE GRADIENT BETWEEN THE VENTRICLE AND THE AORTA, RESULTING IN AN INADEQUATE PRESSURE CHANGE TO CLOSE THE LEAFLETS. IN MANY INSTANCES THIS CAN BE OVERCOME WITH TROUBLE SHOOTING, WHICH INCLUDES BLOOD PRESSURE RECOVERY OR SUPPORT. PER COMPLAINT DESCRIPTION, THE VALVE WAS INITIALLY DEPLOYED WITH 2 ML LESS THAN NOMINAL VOLUME AND THEN POST DILATED WITH 1 ML MORE THAN NOMINAL VOLUME. ACCORDING TO IFU/TRAINING MANUAL, THE DELIVERY SYSTEM REQUIRES A PRESCRIBED VOLUME FOR THV DEPLOYMENT AND PROPER FUNCTION. ALTHOUGH IMAGERY REVIEW REVEALED THAT THE THV APPEARS FULLY EXPANDED AFTER POST-DILATATION, OVER-INFLATION OF THE VALVE MAY HAVE RESTRICTED THE MOTION OF THE LEAFLETS AND LED TO ABNORMAL COAPTATION AND CENTRAL REGURGITATION AS REPORTED IN THE COMPLAINT. ADDITIONALLY, GIVEN THE PATIENT¿S ANATOMICAL CONDITIONS (BORDERLINE ANNULUS MEASUREMENTS AND HEAVILY CALCIFIED AORTIC VALVE WITH SMALL STJ), IT WOULD HAVE BEEN RECOMMENDED TO USE A SMALLER THV SIZE (26MM VS 29MM) PER TRAINING MANUAL. INCORRECT VALVE SIZING COULD IMPAIR THE VALVE PERFORMANCE AND LEAD TO COMPLAINT EVENT AS OBSERVED IN THIS CASE. IN THIS CASE, THE DEFINITE ROOT CAUSE OF NON-FUNCTION LEAFLET AND SUBSEQUENT CENTRAL AI WAS UNABLE TO BE DETERMINED. HOWEVER, PROCEDURAL FACTORS (INCORRECT VALVE SIZING AND/OR IMPROPER INFLATION VOLUME) AND/OR OTHER AFOREMENTIONED PATIENT AND/OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS COMPLAINT EVENT. THE COMPLAINTS OF ¿LEAFLET ¿ MOTION RESTRICTED-IN PATIENT¿ AND ¿VALVE ¿ REGURGITATION-CENTRAL LEAK WERE CONFIRMED BASED ON THE REVIEW OF IMAGERY BUT NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. HOWEVER, A REVIEW OF DHR, COMPLAINT HISTORY, LOT HISTORY, AND MANUFACTURING MITIGATIONS DID NOT PROVIDE ANY INDICATION THAT MANUFACTURING NON-CONFORMANCES CONTRIBUTED TO THE COMPLAINT EVENT. SINCE NO LABELING OR IFU/TRAINING INADEQUACIES WERE IDENTIFIED AND REVIEW OF THE COMPLAINT HISTORY REVEALED THAT THE OCCURRENCE RATE DID NOT EXCEED THE MAY 2017 CONTROL LIMITS FOR APPLICABLE TREND CATEGORIES, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW WAS PERFORMED ON THE PROVIDED PROCEDURAL CINE AND PROCEDURAL ECHO. PRE-OP CT: UNABLE TO DOWNLOAD TO RECREATE 3MENSIO REPORT FOR ANNULAR MEASUREMENTS. 3MENSIO REPORT FROM FCS: MEASUREMENTS ARE BORDERLINE FOR A 26MM OR 29MM WITH SMALL STJ (26.9). PROCEDURAL CINE: HEAVILY CALCIFIED AORTIC VALVE; CORONARY STENTS SEEN IN RCA AND LAD SYSTEM; FIRST BAV NOT EFFECTIVE AS THE BALLOON SLIPS INTO AORTA; SECOND BAV EFFECTIVE (HOWEVER, NO CONTRAST INJECTION TO HELP DETERMINE VALVE SIZING); UNDEPLOYED VALVE AND DELIVERY SYSTEM SEEN IN DESCENDING AORTA. NO IMAGES OF ACTUAL VALVE ALIGNMENT; VALVE ACROSS ANNULUS, VIEW IS NOT COAXIAL; NICE SLOW INFLATION; VALVE APPEARS TOO LARGE AS THE FRAME TOUCHES AND EXPANDS THE STJ; VALVE APPEARS 70:30 (A/V); ANGIOGRAM SHOWS CENTRAL AI WITH WIRE STILL ACROSS VALVE; POST DILATION X2; ANGIOGRAM SHOWS CENTRAL AI WITH ANOTHER PIG TAIL ACROSS VALVE; VIV DONE WELL AND DEPLOYED IN SAME POSITION AS FIRST VALVE; NO IMAGE PROVIDED OF ANGIOGRAM POST VIV PROCEDURAL ECHO: FIRST VALVE DEPLOYED APPEARS SLIGHTLY TOO LOW IN LV · CENTRAL REGURGITATION SEEN WITH AND WITHOUT WIRE ACROSS ANNULUS · PVL CONFIRMED (LCC) · POST DILATION SEEN · CENTRAL AI CONFIRMED WITH WIRE OUT. IMPRESSION/RECOMMENDATIONS: UNABLE TO RE-MEASURE ANNULUS TO CONFIRM CORRECT VALVE SIZE DUE TO FORMAT OF CT IMAGES PROVIDED. NATIVE AORTIC VALVE HEAVILY CALCIFIED WITH CORONARY STENTS VISIBLE. SECOND BAV EFFECTIVE. NO IMAGES PROVIDED OF VALVE ALIGNMENT. FIRST VALVE DEPLOYED WITH NICE SLOW INFLATION. VALVE APPEARS TOO LARGE FOR ANNULUS AS THE VALVE TOUCHES AND ENLARGES THE STJ. CENTRAL AI SEEN WITH WIRE ACROSS. TVL/ PVL CONFIRMED FROM TEE. FIRST VALVE POST DILATED X2. VALVE IS FULLY EXPANDED. CENTRAL AI WITH ONE NON-FUNCTION LEAFLET CONFIRMED FROM TEE. VIV DONE WELL. NO AI OR PVL SEEN. UNABLE TO IDENTIFY ROOT CAUSE OF NON-FUNCTION LEAFLET WITH SUB SEQUENT AI. WITH BORDERLINE ANNULUS MEASUREMENTS AND HEAVY CALCIFICATION, RECOMMEND BAV WITH GOOD CONTRAST INJECTION TO HELP DETERMINE VALVE SIZING. THE SAPIEN 3 VALVE SHOULD NOT BE IMPLANTED WITH LESS VOLUME THAN SUGGESTED IN THE IFU IN ORDER TO HAVE NORMAL FUNCTION OF THE LEAFLETS. INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN (B)(6), DURING A TRANSFEMORAL TAVR PROCEDURE, RESTRICTED MOTION OF THE RIGHT CORONARY CUSP (RCC) WAS OBSERVED. A 29MM SAPIEN 3 (S3) VALVE WAS IMPLANTED WITH 2ML LESS THAN NOMINAL VOLUME. THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED MILD PARAVALVULAR LEAK (PVL) AT 1-2 O¿CLOCK DIRECTION AND CENTRAL AORTIC REGURGITATION (AR). THE CENTRAL AR WAS THOUGHT TO BE CAUSED BY GUIDEWIRE. POST DILATION WAS EXECUTED WITH 1ML MORE THAN NOMINAL VOLUME. IT WAS DECIDED NOT TO POST DILATE AGAIN AND DELIVERY SYSTEM AND GUIDEWIRE WERE REMOVED. TEE CONFIRMED THAT THE PVL WAS LESSENED TO MILD; HOWEVER, LOCALIZED MODERATE CENTRAL AR FROM RCC WAS CONFIRMED. IT WAS THOUGHT THAT THE RCC MAY BE FROZEN AT OPEN POSITION. THE PHYSICIAN MANIPULATED THE PIGTAIL CATHETER TO TOUCH THE RCC SO THAT THE MOTION OF THE RCC WOULD BE IMPROVED AND CENTRAL AR WOULD BE STOPPED. SINCE THE HEMODYNAMIC WAS STABLE, THE PHYSICIAN DECIDED TO WAIT FOR 10 MINUTES TO SEE IF THE CENTRAL AR WOULD STOP. THE CENTRAL AR WAS NOT RESOLVED OR LESSENED. THE VALVE IN VALVE PROCEDURE WAS EXECUTED. THE SECOND S3 WAS IMPLANTED IN SAME POSITION AS THE FIRST VALVE WITH 2ML LESS THAN NOMINAL VOLUME. NO ABNORMALITY WAS OBSERVED FOR THE MOTION OF THE SECOND VALVE AND IT WAS CONFIRMED THAT THE CENTRAL AR WAS RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: THE POST DILATION WAS PERFORMED WITH -1ML LESS THAN NOMINAL VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372976 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX29J N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention