EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 23MM
Report
- Report Number
- 2015691-2019-03258
- Event Type
- Death
- Date Received
- August 30, 2019
- Date of Event
- August 13, 2019
- Report Date
- August 13, 2019
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
CORRECTED DATA: F10, H6. REFERENCE (B)(4).
THIS IS ONE OF TWO REPORTS BEING SUBMITTED FOR THIS CASE. REFERENCE MFG. REPORT NO. 2015691-2019-003260.
THE SAPIEN 3 TRANSCATHETER HEART VALVE WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. WITHOUT THE DEVICE RETURNED FOR EVALUATION, VISUAL INSPECTION, FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS WERE UNABLE TO BE COMPLETED. A 3MENSIO OF THE PATIENT¿S ANATOMY AND PHOTO OF THE DAMAGED FRAME BY FLUORO WAS PROVIDED AND REVIEWED. THE REVIEW REVEALED THAT THE PATIENT HAD SEVERELY CALCIFIED ANATOMY AND THE VALVE FRAME WAS DEFORMED (BENT STRUTS) AND TILTED FROM THE CATHETER. DURING MANUFACTURING, ALL SAPIEN 3 ASSEMBLIES UNDERGO SEVERAL TESTING AND INSPECTIONS. THE IN-PROCESS SAPIEN 3 VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS DURING MANUFACTURING PER PROCEDURE. THE FRAME COMPONENTS ARE 100% VISUALLY AND DIMENSIONALLY INSPECTED BY BOTH MANUFACTURING AND QUALITY FOR ANY DAMAGE. IN ADDITION, PER PROCEDURE, THE FRAMES ARE MECHANICALLY TENSILE TESTED ON A SAMPLING BASIS. THE COMPONENTS ARE 100% VISUALLY INSPECTED BY MANUFACTURING. PRIOR TO FINAL PACKAGING, 100% VISUAL INSPECTION IS PERFORMED AT PRELIMINARY PACKAGING PER PROCEDURE TO ENSURE NO DAMAGE WAS DONE TO THE VALVE FROM HANDLING BETWEEN HOLDER INSPECTION AND THE BREP PROCESS. THESE MANUFACTURING INSPECTIONS SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NONCONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINT. THE DEVICE HISTORY RECORD WAS REVIEWED AND REVEALED MANUFACTURING NON-CONFORMANCE REPORT RELEVANT TO THE EVALUATION. SINCE THE NONCONFORMANCE HAS NO PATIENT RISK AND ONLY GOOD PARTS WERE REJECTED, IT IS UNLIKELY THAT THE NONCONFORMANCE IDENTIFIED IN THESE WORK ORDERS CONTRIBUTED TO THIS COMPLAINT EVENT. A LOT HISTORY REVIEW DID NOT REVEAL ANY OTHER COMPLAINTS RELATED TO THIS EVENT. A REVIEW OF COMPLAINT HISTORY FOR THE SAPIEN 3 (ALL SIZES) FROM (B)(6) 2018 TO (B)(6) 2019 REVEALED OTHER RETURNED COMPLAINTS FOR FRAME DAMAGE DURING USE. THE COMPLAINTS WERE REVIEWED BASED ON SIMILAR REPORTED EVENTS AND ASSOCIATED ROOT CAUSES/EVALUATION CODES. NO MANUFACTURING NON-CONFORMITIES WERE IDENTIFIED. AVAILABLE INFORMATION SUGGESTS THAT PATIENT/PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. (B)(4). THE PATIENT SCREENING MANUAL PRESCRIBES SPECIFIC TESTING TO DETERMINE SUITABILITY FOR DELIVERING THE THV, INCLUDING CTA OF CHEST-ABDOMEN-PELVIS, AND EVALUATION OF THE AORTIC ARCH TO ASSESS THE DEGREE OF ARCH ANGULATION AND STENOSIS. IT EXPLAINS THAT ACUTE AORTIC ARCH ANGLES AND UNFOLDED AORTAS MAY BE MORE DIFFICULT TO NAVIGATE THE VALVE CATHETER AND ACHIEVE PROPER VALVE POSITIONING. IT ALSO NOTES THAT FOR THE TRANSFEMORAL APPROACH, DECREASED DIAMETERS CAN LIMIT DELIVERY SYSTEM MANIPULATION. PRIOR TO THE TAVR PROCEDURE, THE PATIENT¿S SUITABILITY FOR TRANSFEMORAL DELIVERY OF THE TRANSCATHETER HEART VALVE MUST BE ASSESSED WITH A THOROUGH SCREENING OF THE AORTO-ILLIAC AND ILIO-FEMORAL REGIONS USING MDCT, ANGIOGRAPHY AND IVUS TO DETERMINE VESSEL DIAMETER AND DEGREE OF CALCIFICATION AND TORTUOSITY. THE PATIENT SCREENING MANUAL STATES THAT CALCIFICATION CAN DRASTICALLY REDUCE PERIPHERAL VESSEL DIAMETERS AND MUST BE THOROUGHLY ASSESSED TO ENSURE SHEATH COMPATIBILITY. THE TRAINING MANUAL INSTRUCTS THE USER TO ENSURE THE EDWARDS LOGO IS FACING UP ON THE DELIVERY SYSTEM WHEN TRACKING OVER THE AORTIC ARCH, AND TO USE 30 DEGREES TO 40 DEGREES LAO TO PROVIDE VIEW OF THE AORTIC ARCH. IT STATES TO SLOWLY ROTATE THE FLEX WHEEL AWAY FROM YOU WHILE TRACKING OVER THE AORTIC ARCH. INSTRUCTION TO FACILITATE CROSSING THE VALVE INCLUDES: ENSURE THE FLEX CATHETER TIP IS FLUSH WITH THE THV FOR SUPPORT DURING CROSSING; BE PATIENT! DO NOT FORCE THE THV; USE SHORT MOVEMENTS TO PREVENT JUMPING OF THE THV INTO THE VENTRICLE; USE RAO OR AP PROJECTION TO ENSURE WIRE POSITION IS MAINTAINED IN THE VENTRICLE. THE TRAINING MANUAL HIGHLIGHTS THE FOLLOWING AS FACTORS THAT MAKE IT DIFFICULT TO CROSS: HEAVY CALCIFICATION, WIRE BIAS INTO THE COMMISSURE, HORIZONTAL AORTA, TORTUOUS THORACIC AORTA, FLEX CATHETER KINKED, AND INADEQUATE BAV. IF DIFFICULTY IS EXPERIENCED DURING CROSSING, THE USER IS INSTRUCTED TO MAKE SURE THE WIRE IS CORRECTLY POSITIONED AT THE APEX; PULL TENSION ON THE WIRE OR REPOSITION; ADD SOME DISTAL FLEX OR REMOVE SOME PARTIAL FLEX; PULL THE SYSTEM BACK AND RE-ADVANCE. IF EFFORTS TO TRACK OVER THE AORTIC ARCH AND CROSS THE AORTIC VALVE ARE UNSUCCESSFUL, THE CRIMPED THV CAN BE RETRIEVED INTO THE ESHEATH. THE USER IS INSTRUCTED TO ENSURE THE THV IS CENTERED ON THE FLEX TIP WITH THE DELIVERY SYSTEM LOCKED; VERIFY THE FLEX CATHETER IS COMPLETELY UNFLEXED; RETRACT THE THV AND DELIVERY SYSTEM INTO THE SHEATH ENSURING THE THV IS COMPLETELY INSIDE THE SHEATH AND JUST PAST THE SHEATH TIP; ENSURE THE EDWARDS LOGO ON THE SHEATH HANDLE IS FACING UPWARD; WITHDRAW THE DELIVERY SYSTEM AND SHEATH AS A SINGLE UNIT COMPLETELY FROM THE ARTERIOTOMY WHILE MAINTAINING GUIDEWIRE POSITION; DO NOT RE-USE THE SHEATH, THV OR DELIVERY SYSTEM ONCE THE THV IS RETRIEVED. THE TRAINING MANUAL EXPLAINS THAT THE CRIMPED THV ALIGNED ON THE BALLOON IS LARGER THAN THE CRIMPED THV OFF THE BALLOON; TAKE CARE IF DECIDING TO RETRIEVE. THE FOLLOWING NOTE IS ALSO HIGHLIGHTED: DO NOT FORCE THE THV INTO THE SHEATH. IF RESISTANCE IS FELT, THE THV MAY BE CAUGHT ON THE SHEATH TIP. STOP, ADVANCE THE THV PAST THE SHEATH TIP AND ENSURE THE THV IS CENTERED ON THE FLEX TIP. ROTATE THE DELIVERY SYSTEM BEFORE TRYING AGAIN. THERE WAS NO IFU OR TRAINING DEFICIENCIES IDENTIFIED. THERE MAY BE CASES IN WHICH THE VALVE IS NOT ABLE TO BE DEPLOYED AT THE INTENDED LOCATION FOR VARIOUS REASONS. THIS MAY REQUIRE DEPLOYING THE VALVE AT A NON-TARGET LOCATION, TYPICALLY IN THE DESCENDING AORTA. ALTHOUGH, GENERALLY WELL TOLERATED, THE LONG-TERM EFFECTS ARE NOT COMPLETELY UNDERSTOOD. PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ASCENDING AORTIC DISSECTION MAY OCCUR WHEN MULTIPLE ATTEMPTS ARE MADE TO CROSS THE STENOTIC NATIVE VALVE, AND/OR WHEN EXCESSIVE FORCE IS USED. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV). THE THV TRAINING MANUALS PROVIDE GUIDANCE TO FACILITATE SAFE CROSSING OF THE NATIVE VALVE, INCLUDING CAMERA PROJECTIONS, HANDLING DURING ADVANCEMENT, AND TROUBLESHOOTING TECHNIQUES IF DIFFICULTY IS ENCOUNTERED. THE COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED IMAGERY. DUE TO THE UNAVAILABILITY OF THE DEVICE, ENGINEERING WAS UNABLE TO PERFORM FULL VISUAL, FUNCTIONAL, OR DIMENSIONAL ANALYSIS. AS A RESULT, PRESENCE OF A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED. HOWEVER, A REVIEW OF THE DHR AND MANUFACTURING MITIGATIONS DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT. ADDITIONALLY, A REVIEW OF THE IFU AND TRAINING MANUAL REVEALED NO DEFICIENCIES. PER REPORT, PATIENT HAD SEVERELY AORTA CALCIFICATION, AND THE DELIVERY SYSTEM/VALVE HAD DIFFICULTY FOR ADVANCEMENT/RETRIEVAL DUE TO THE VALVE WAS BEING CAUGHT ONTO THE CALCIFICATION. PATIENT FACTORS SUCH AS CALCIFICATION CAN CREATE DIFFICULTY PATHWAYS FOR DEVICE ADVANCEMENT/RETRIEVAL. IN SUCH CONDITION, ADDITIONAL DEVICE MANIPULATION TO FURTHER ADVANCE/RETRIEVE THE DELIVERY SYSTEM MAY HAVE DAMAGED THE VALVE. IN THIS CASE, AVAILABLE INFORMATION SUGGESTS PATIENT (CALCIFICATION, EXTENSIVE VASCULAR DISEASE) AND/OR PROCEDURAL (DEVICE MANIPULATION - PUSH/PULL FORCE) FACTORS MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. NO MANUFACTURING NONCONFORMANCE WAS IDENTIFIED DURING EVALUATION. NO LABELING OR IFU/TRAINING INADEQUACIES WERE IDENTIFIED. (B)(4); THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED AT THIS TIME.
THE OPERATIVE REPORT WAS PROVIDED AND REVIEWED. AN ATTEMPT AND SUBSEQUENTLY ABORTED TAVR PROCEDURE WITH 23MM SAPIEN 3 VALVE. DURING ACCESS, A 6 MM BALLOON WAS USED TO DILATE LEFT AORTOILIAC JUNCTION AS WELL AS MID ABDOMINAL AORTA DUE TO SEVERE AORTIC CALCIFIC OCCLUSIVE DISEASE AND ATHEROSCLEROTIC PLAQUE. AFTER SOME DIFFICULTY THE AORTIC VALVE WAS CROSSED AND A BALLOON VALVULOPLASTY WAS PERFORMED WITH A 20-MM BALLOON. AN ATTEMPT WAS MADE TO ADVANCE THE 23MM VALVE WITHOUT SUCCESS. THE SHEATH WAS ABLE TO BE ADVANCED ABOVE NARROWING IN THE ABDOMINAL AORTA; HOWEVER, THE VALVE COULD NOT BE ADVANCED. ABDOMINAL AORTA WAS DILATED WITH A 7MM BALLOON AND AGAIN ATTEMPTS WERE MADE TO PASS WITHOUT SUCCESS. THE VALVE WAS ATTEMPTED TO BE RETRIEVED INTO THE SHEATH, BUT DIFFICULTY WAS ENCOUNTERED DUE TO EXTENSIVE ATHEROSCLEROTIC DISEASE. THE VALVE WAS A 23MM AND CT OF ABDOMINAL AORTA MEASUREMENTS WERE AROUND 18MM, SO THERE WAS CONCERN FOR PERFORATION IF DEPLOYING VALVE IN THE ABDOMINAL AORTA. THE DELIVERY CATHETER WAS WITHDRAWN, AND THE STENTED VALVE REMAINED IN THE ABDOMINAL AORTA. A COVERED STENT WAS PLACED NEXT TO THE UNDEPLOYED VALVE AND WAS EXPANDED AND COMPRESSED AGAINST THE WALL, EXCLUDING THE FOREIGN BODY VALVE FROM AORTIC CIRCULATION. A POST DILATION OF A COVERED STENT WAS PERFORMED. GOOD POSITION AND SEAL ZONE WITH GOOD FLOW DOWN BILATERAL ILIAC ARTERIES DISTALLY WERE OBSERVED. A COMPLETE HEART BLOCK WAS PRESENT FROM VALVULOPLASTY AND A PERMANENT PACEMAKER WAS INSERTED. THE PATIENT WAS TRANSFERRED TO ICU IN GUARDED CONDITION. THE PATIENT¿S CONDITION RAPIDLY DETERIORATED AND THE FAMILY PROCEEDED WITH DNR. THE PATIENT¿S EJECTION FRACTION WAS 15-20% AND THE LEFT VENTRICULAR FUNCTION WAS SEVERELY REDUCED. THERE WAS EXTENSIVE REGIONAL DISEASE INVOLVING THE ANTERIOR WALL, IVS AND APEX. THE LEAFLETS WERE SEVERELY CALCIFIED.
INVESTIGATION IS ONGOING.
PRECEDING A TRANSFEMORAL TAVR WITH A 23MM SAPIEN 3, THE PATIENT HAD KNOWN ARTERIAL DISEASE WITH CALCIFICATION SO PRE-DILATION OF THE ILIAC AND AORTA WAS PERFORMED PRIOR TO ESHEATH INSERTION. DURING A TRANSFEMORAL PROCEDURE, A 14FR ESHEATH WAS INSERTED WITHOUT ANY DIFFICULTY. DURING INSERTION OF THE COMMANDER DELIVERY SYSTEM INTO THE 14 FR ESHEATH, RESISTANCE WAS NOTED. UPON FURTHER INSERTION, THE DELIVERY SYSTEM/VALVE WAS ¿GETTING CAUGHT¿ IN THE THORACIC AORTA DUE TO EXTREMELY CALCIFICATION. THE VALVE COULD NOT BE ADVANCED ANY FURTHER AND THE OPERATOR WAS UNABLE TO GO FORWARD OR BACKWARD WITH THE SYSTEM. THE VALVE WAS CAUGHT BETWEEN TWO ¿GIANT¿ PIECES OF CALCIUM, ONE IN THE FRONT OF THE VALVE AND THE OTHER IN THE BACK OF THE VALVE AND COULD NOT BE RETRIEVED. THE VALVE HAD BECOME DISLODGED FROM THE BALLOON AND A DECISION WAS MADE TO LEAVE THE UNDEPLOYED VALVE IN THE THORACIC AORTA. THE VALVE WAS THEN ¿CRUSHED¿ IN THE THORACIC AORTA AND A COVERED STENT WAS PLACED TO SECURE THE VALVE. DURING MANIPULATION, THE VALVE BECAME ¿DISFIGURED¿ AND DAMAGE TO THE STENT STRUTS WERE NOTED. A VASCULAR SURGEON WAS CALLED TO REVIEW THE EVENT. A DECISION WAS MADE TO REMOVE THE DELIVERY SYSTEM THROUGH THE SHEATH AND THE SYSTEM WAS SUCCESSFULLY REMOVED AS A UNIT WITHOUT INJURY TO THE PATIENT. THE CASE WAS ABORTED, AND THE PATIENT WAS STABLE. OF LAST COMMUNICATION, APPROXIMATELY 2 DAYS POST PROCEDURE, THE PATIENT EXPIRED. THE ¿UNOFFICIAL¿ CAUSE OF DEATH WAS ABDOMINAL AORTA DISSECTION AND HEMATOMA THAT CAUSED OCCLUSION OF MESENTERIC ARTERY. NO OTHER IMAGING CAN BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745915 | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 23MM | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9600TFX23A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Death| R |