EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

Report

Report Number: 2015691-2020-12738
Event Type: Death
Date Received: July 28, 2020
Date of Event: May 29, 2020
Report Date: July 23, 2020
Manufacturer: EDWARDS LIFESCIENCES
Product Code: NPT
PMA / PMN Number: P140031
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

SUPPLEMENTAL REPORT TO ADD NOE STATEMENT IN B5 SECTION, AND PROVIDE D5, AND H6 INFORMATION.

Description of Event or Problem · 0

THIS REPORT SUMMARIZE <NOE> 5 </NOE> EVENTS OF UNPLANNED OTHER CARDIAC SURGERY OR INTERVENTION DEATH EVENTS FOR THE SAPIEN 3 ULTRA FOR (B)(6) 2020.

Additional Manufacturer Narrative · 1

EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 5 EVENTS OF UNPLANNED OTHER CARDIAC SURGERY OR INTERVENTION FOR THE SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 1.8. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE ARE: (B)(4). THE INSTRUCTIONS FOR USE (IFU) LIST REOPERATION, INCLUDING EMERGENCY CARDIAC SURGERY, AS ADDITIONAL POTENTIAL RISKS ASSOCIATED WITH THE USE OF THE THV, DELIVERY SYSTEM, AND/OR ACCESSORIES. THIS EVENT TYPE (UNPLANNED OTHER CARDIAC SURGERY OR INTERVENTION) IS DEFINED AS: THE PATIENT SUBSEQUENTLY UNDERWENT OTHER TYPES OF CARDIAC SURGERY OR CATH LAB INTERVENTIONS (NOT OTHERWISE SPECIFIED) THAT WAS UNPLANNED. THIS COULD INCLUDE REOPERATION FOR DAMAGE TO ADJACENT STRUCTURES, SUCH AS THE MITRAL APPARATUS, OR POTENTIALLY VALVE EXPLANT RELATED TO EMBOLIZATION, OR OTHER EVENT TYPES. CARDIOVASCULAR INJURY, INCLUDING PERFORATION OR DISSECTION OF VALVULAR STRUCTURES [E.G. INJURY TO THE MITRAL VALVE/ APPARATUS], AND VALVE EMBOLIZATION REQUIRING INTERVENTION ARE KNOWN POTENTIAL COMPLICATIONS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU). CHORDAE TENDINEA RUPTURE IN TAVR CAN OCCUR DURING ADVANCEMENT OF THE GUIDEWIRE, BAV CATHETER, OR DELIVERY SYSTEM AND IS MOST LIKELY TO OCCUR WITH ANTEGRADE APPROACHES, HOWEVER, CAN OCCUR WITH A RETROGRADE APPROACH. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVES (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, AND CAREFUL MANIPULATION OF DEVICES. PER THE THV TA TRAINING MANUALS, AFTER GAINING LV ACCESS WITH THE 0.035¿ SOFT GUIDEWIRE, THE WIRE SHOULD BE JIGGLED UNDER TEE IMAGING OF THE MITRAL VALVE. AN INCREASE IN MR SUGGESTS WIRE ENTANGLEMENT IN THE MITRAL SUB-VALVULAR APPARATUS. IF ENTANGLEMENT IS SUSPECTED, THE GUIDEWIRE SHOULD BE COMPLETELY REMOVED FROM THE VENTRICLE; THE OPERATOR SHOULD CHANGE DIRECTION OF THE NEEDLE AND REINSERT THE GUIDEWIRE INTO THE VENTRICLE, CHECKING AGAIN FOR WIRE ENTANGLEMENT. THE TF TRAINING MANUAL ALSO PROVIDES GUIDANCE FOR VALVE CROSSING AND WIRE EXCHANGE: EXCHANGE 0.035¿ AMPLATZ EXTRA-STIFF WIRE WITH PRE-SHAPED DISTAL END IN LEFT VENTRICLE. ENSURE GUIDE CATHETER IS ADVANCED UPON WIRE EXCHANGE TO ENSURE EXCHANGE WIRE DOES NOT GET CAUGHT IN THE MITRAL CHORDAE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMALLY OR BULKY/SEVERELY CALCIFIED AORTIC LEAFLETS, RAPID DEPLOYMENT, RELEASE OF STORED TENSION DURING DEPLOYMENT, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE 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 EMBOLIZATION (I.E. SMALL, CALCIFIED STJ, MINIMAL LEAFLET CALCIFICATION), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE, SPECIFIC PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS, OR IF THE EVENT IS RELATED TO AN EDWARDS DEVICE. 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 AT THIS TIME.

Description of Event or Problem · 1

THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR (B)(6) 2020 DATA EXTRACT FOR AORTIC DEATH EVENTS FOR THE SAPIEN 3 ULTRA VALVE. THIS REPORT SUMMARIZES 5 EVENTS OF UNPLANNED OTHER CARDIAC SURGERY OR INTERVENTION IN THE AORTIC POSITION DEATH EVENTS FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE FOR (B)(6) 2020. THE AGE RANGE FOR THESE EVENTS IS FROM 76-88. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 4 FEMALES AND 1 MALE. (B)(6) 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR Q4 2019 (OCTOBER 1 ¿ DECEMBER 31).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
796204	EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE	AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED	NPT	EDWARDS LIFESCIENCES	9750TFX	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR		Death