EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

Report

Report Number: 2015691-2015-00083
Event Type: Injury
Date Received: January 12, 2015
Date of Event: December 16, 2014
Report Date: December 16, 2014
Manufacturer: EDWARDS LIFESCIENCES
Product Code: NPT
PMA / PMN Number: P130009
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NZ
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CINE IMAGES WERE PROVIDED AND REVIEWED BY AN EDWARDS PHYSICIAN PROCTOR. OBSERVATIONS: · SEVERE CALCIFICATION WITH SEVERE AI · THE WIRE IS IN PERFECT POSITION · FROM THE FIRST INJECTION OF CONTRAST A DOUBLE LINE OF CALCIUM CAN BE SEEN ON THE NCC, WHERE THE REAL SINUS IS ABOVE, WHILE THE SECOND LINE IS CALCIUM IN THE LVOT. · THE VALVE IS POSITIONED TOO LOW (20/80 ON THE NCC, AND 40/60 IN THE LCC) AND IS NOT COAXIAL. · THE VALVE AND DS WERE UNSTABLE DURING DEPLOYMENT. · RESPIRATIONS WERE NOT HELD. · POST DEPLOYMENT THE VALVE WAS NOT FULLY EXPANDED ON THE PROXIMAL PORTION (AORTIC SIDE) · A VALVE IN VALVE WAS PERFORMED. GOOD POSITION INITIALLY. THE VALVE AND DS WERE UNSTABLE DURING DEPLOYMENT RESULTING IN TOO VENTRICULAR FINAL POSITION. MILD-MODERATE REGURGITATION POST DEPLOYMENT. IMPRESSIONS: THE VALVE WAS POSITIONED ON LVOT CALCIFICATION, AND NOT THE TRUE SINUS, RESULTING IN DEPLOYMENT OF THE VALVE TOO VENTRICULAR. PER THE INSTRUCTIONS FOR USE (IFU), DEVICE MALPOSITION AND PARAVALVULAR LEAK (PVL) ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMALLY CALCIFIED AORTIC LEAFLETS, LOSS OF PACING CAPTURE, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE IN A NATIVE AORTIC 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 VENTRICULAR MALPOSITION (I.E. SMALL, CALCIFIED STJ, MINIMAL LEAFLET CALCIFICATION), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC ALSO IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PVL, INCLUDING DEVICE MALPOSITION, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE, BULKY OR SEVERE CALCIFICATION, AN ELLIPTICAL ANNULUS SHAPE AND VALVE UNDER-SIZING. AS THE SAPIEN XT IS NOT INDICATED FOR USE IN A HOMOGRAFT VALVE, SPECIFIC INSTRUCTIONS FOR DEPLOYMENT IN THIS CASE ARE NOT PROVIDED. IN THIS CASE, PER IMAGING REVIEW, THE VALVE APPEARS TO HAVE BEEN POSITIONED BASED ON LVOT CALCIFICATION, AND NOT THE TRUE SINUS, RESULTING IN DEPLOYMENT OF THE VALVE TOO VENTRICULAR. PER REPORT, THE MALPOSITION WAS ATTRIBUTED TO DIFFICULTY EXPERIENCED WHILE ATTEMPTING TO POSITION THE VALVE WITHOUT CLEAR HINGE-POINTS. THE PVL WAS LIKELY DUE TO THE MALPOSITION. 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

AS REPORTED BY THE EDWARDS (B)(4) AFFILIATE, DURING THE TRANSFEMORAL TAVR PROCEDURE, THE SAPIEN XT VALVE WAS DEPLOYED TOO VENTRICULAR WHICH RESULTED IN MODERATE + PARAVALVULAR LEAK (PVL). THE DECISION WAS MADE TO DEPLOY A SECOND VALVE IN A MORE AORTIC POSITION. THE PATIENT PREVIOUSLY HAD A FULL BENTALL PROCEDURE WITH HOMOGRAFT VALVE AND CABG IN 2002. INITIALLY, THE PATIENT PRESENTED WITH SEVERE AORTIC REGURGITATION AND AORTIC STENOSIS AND THE DECISION WAS MADE NOT TO PERFORM A BALLOON VALVULOPLASTY. A SOFT-FILL (30/33ML FILL) 29MM SAPIEN XT VALVE WAS DELIVERED TRANS-FEMORALLY. THE XT VALVE WAS POSITIONED 50:50 BUT DEPLOYED 30:70 AORTIC/VENTRICULAR, THEREFORE A SECOND VALVE WAS QUICKLY PREPARED AND POSITIONED IN A MORE AORTIC POSITION. DURING DEPLOYMENT OF THE SECOND 29MM SAPIEN XT VALVE (31/33ML FILL), 1:1 CAPTURE WAS LOST AND THIS VALVE ENDED UP IN A POSITION ONLY SLIGHTLY HIGHER THAN THE FIRST DEPLOYED VALVE. THE 40:60 A/V POSITION WAS DEEMED ADEQUATE WITH MILD PARAVALVULAR LEAK (PVL) OBSERVED UNDER TEE BETWEEN THE TWO THV VALVES. THE PATIENT WAS EXTUBATED ON THE TABLE AND TAKEN TO CCU TO RECOVER. THE MALPOSITION WAS ATTRIBUTED TO DIFFICULTY EXPERIENCED WHILE ATTEMPTING TO POSITION THE VALVE WITHOUT CLEAR HINGE-POINTS. THE DIASTOLIC AORTIC ANNULUS MEASURED 26MMX25MM BY CT WITH AN AREA OF 498MM². THE IMAGE INTENSIFIER ANGLE WAS NOTED TO BE GOOD, THE COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND VALVE WAS REPORTED TO BE FAIR, VENTILATION WAS NOT HELD AND THERE WAS NO LOSS OF PACING CAPTURE DURING DEPLOYMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
24834	EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE	AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED	NPT	EDWARDS LIFESCIENCES	9300TFX29

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Required Intervention