EDWARDS SAPIEN TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2014-02591
- Event Type
- Death
- Date Received
- November 3, 2014
- Date of Event
- October 6, 2014
- Report Date
- October 6, 2014
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P110021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, AND DEVICE MALPOSITION, ARE KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ACCORDING TO THE THV TRAINING MANUALS, RISK FACTORS FOR ACUTE AORTIC RUPTURE/DISSECTION IN THE TAVR PROCEDURE INCLUDE SIGNIFICANT VALVE OVER SIZING (I.E. =4MM) IN THE PRESENCE OF SEVERELY CALCIFIED AORTIC ROOT AND OBLITERATED SINUSES. THE SAPIEN VALVE RELIES ON NATIVE VALVE CALCIUM TO SECURELY ANCHOR TO THE ANNULUS. DESPITE THIS BENEFICIAL ASPECT OF CALCIUM, BULKY CALCIUM CAN INCREASE THE RISK OF CALCIFIC NODULE DISPLACEMENT INTO THE VASCULATURE, WHICH CAN LEAD TO VASCULAR INJURY. AT TIMES THE EXTENT AND DISTRIBUTION OF CALCIUM CAN IMPAIR EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE AND PROCEDURAL SUCCESS. DEVICE MALPOSITION REQUIRING INTERVENTION IS ALSO A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMALLY OR SEVERELY CALCIFIED AORTIC LEAFLETS, PRESERVED EJECTION FRACTION, SIGNIFICANT MITRAL ANNULAR CALCIFICATION (MAC), 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, 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 AORTIC MALPOSITION (I.E. MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE, PROCEDURAL FACTORS AND OPERATOR HANDLING APPEAR TO HAVE CONTRIBUTED TO THE HIGH PLACEMENT OF THE VALVE [OVERCORRECTION OF THE VALVE/DELIVERY SYSTEM BY THE OPERATOR WHEN THE VALVE BEGAN TO SHIFT DURING DEPLOYMENT]. PROCEDURAL FACTORS [POSSIBLE VALVE OVERSIZING IN CONJUNCTION WITH TOO HIGH PLACEMENT OF THE VALVE] CONTRIBUTED TO THE ANNULAR RUPTURE. PER THE CASE PHYSICIAN, THE VALVE STENT WAS TOUCHING THE STJ (IN CORRESPONDENCE TO THE TEAR). 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.
DURING A TRANSAPICAL TAVR PROCEDURE, A TEAR AT THE LEVEL OF THE SINOTUBULAR JUNCTION [STJ] WAS DETECTED RIGHT ABOVE THE LEFT MAIN. THE RUPTURE WAS REPAIRED; THE PATIENT WAS TRANSFERRED TO ICU, AND EXPIRED THAT EVENING. DURING THE PROCEDURE THE PHYSICIANS HAD CONCERN FOR RISK OF CORONARY OCCLUSION; THEREFORE A GUIDEWIRE AND PCI BALLOON WERE POSITIONED AS A PRECAUTIONARY MEASURE IN THE LEFT CIRCUMFLEX [LCX] PRIOR TO VALVE DEPLOYMENT. THE PATIENT HAD A PATENT LIMA LAD GRAFT. A BAV WAS NOT PERFORMED. THE VALVE WAS CHECKED WITH TEE. THE SAPIEN VALVE WAS POSITIONED 50:50, HOWEVER, MOVED VENTRICULAR DURING DEPLOYMENT AND DUE TO OVERCORRECTION OF THE VALVE/DELIVERY SYSTEM BY THE OPERATOR, THE VALVE LANDED 80:20 AORTIC: VENTRICULAR. THE VALVE WAS CHECKED WITH TEE AND THERE WAS MILD PARAVALVULAR LEAK AND ZERO CENTRAL AORTIC INSUFFICIENCY. THE GUIDEWIRE AND PCI BALLOON WERE REMOVED FROM THE LCX. AFTER A WHILE, WITH THE TA SHEATH STILL IN PLACE, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND THE BLOOD PRESSURE WAS DROPPING. AT THIS TIME, TEE SHOWED LATERAL WALL AKINESIA. THE LCA WAS AGAIN CATHETERIZED AND ANGIOGRAM OF THE LCX REVEALED REDUCED FLOW. DUE TO EXTREMELY IMPAIRED HEMODYNAMICS, CPR WAS PERFORMED AND A FEM-FEM BYPASS WAS PROMPTLY INITIATED. A SECOND LCX ANGIOGRAM REVEALED A PATENT LM AND LAD/LCX, HOWEVER THERE WAS DYE EXTRAVASATION FROM THE AORTIC ROOT, NEXT TO THE LEFT MAIN. THERE WAS NO PERICARDIAL BLEEDING BECAUSE OF THE STRONG ADHESIONS FROM PRIOR SURGICAL PROCEDURES. THE STJ WAS NARROW (22MM) AND CALCIFIED. THE NATIVE ANNULUS WAS 22MM BY TEE. THERE WAS AN IMMEDIATE RUPTURE POST VALVE DEPLOYMENT WHICH CAUSED A GROWING HEMATOMA AND COMPRESSION OF THE LCA. MYOCARDIAL ISCHEMIA AND HEMODYNAMIC IMPAIRMENT WERE NOT IMMEDIATELY EVIDENT DUE TO THE PATENCY OF THE LIMA TO LAD GRAFT. EVENTUALLY THE HEMATOMA SPREAD, FINDING DIFFERENT PATHS; THE PRESSURE OF THE HEMATOMA DROPPED, RELEASING THE COMPRESSION OF THE CORONARY ARTERY. HOWEVER, TEE REVEALED AN EXPANDING HEMATOMA AND BLEEDING BETWEEN THE LA AND THE AORTA. THERE WAS ALSO A PRESSURE DROP WITHOUT SIGN OF MYOCARDIAL ISCHEMIA. THE DECISION WAS MADE TO CONVERT TO OPEN CHEST SURGERY TO REPAIR THE AORTIC RUPTURE. STERNOTOMY WAS PERFORMED, CARDIOPLEGIA WAS ADMINISTERED AND THE AORTA WAS OPENED. A TEAR AT THE LEVEL OF THE STJ WAS DETECTED RIGHT ABOVE THE LEFT MAIN. NO OTHER LESIONS WERE SEEN. THE SAPIEN VALVE WAS STILL CIRCULAR AND WELL EXPANDED, WITH GOOD SEALING; HOWEVER, IT WAS A LITTLE TOO HIGH AND THE STENT WAS TOUCHING THE STJ (IN CORRESPONDENCE TO THE TEAR). IT WAS FELT THAT THE HIGHER POSITION WAS RESPONSIBLE FOR THE TEAR. THE SURGEON DECIDED TO LEAVE THE SAPIEN VALVE IN PLACE AND TO REPAIR THE RUPTURE SURGICALLY. PLEDGETS WERE PLACED TO PROTECT THE AORTA FROM CONTACT WITH THE VALVE STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702962 | EDWARDS SAPIEN TRANSCATHETER HEART VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9000TFX26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Death| R |