MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 20MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX20A

Device Problems Failure to Align (2522); Positioning Problem (3009)

Patient Problems Calcium Deposits/Calcification (1758); Low Blood Pressure/ Hypotension (1914); Aortic Dissection (2491); Pericardial Effusion (3271)

Event Date 10/02/2019

Event Type  Death  

Manufacturer Narrative

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.As stated, excessive force should not be used when the device has difficulty crossing the stenotic valve.Adding tension to the wire, pulling back the system to re-orient the valve, as needed, and torquing of the flex catheter may be helpful in solving the problem.In this case, the cause for the aortic dissection cannot be determined; however, procedural factors (device manipulation, device deployed during cpr) may have contributed to the event.There was no allegation or indication a device malfunction contributed to this adverse event.  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.This is one of two reports being submitted for this case.Reference mfg.Report no.2015691-2019-03980.

Event Description

During a transfemoral procedure, with a 20mm sapien 3 valve using a commander delivery system with a 14fr esheath, no bav was performed and a planned basilica procedure was completed before the tavr.An effusion was noted and the patient started to decompensate.The patient's pressure dropped and a commander delivery system with valve was urgently inserted while cpr was being performed.  this made it difficult to perform valve alignment visually due to the movement from the cpr.  during valve alignment, the valve ¿moved distal past the balloon on to the nosecone.¿ a decision was made to remove the delivery system leaving the undeployed valve on the wire.A peripheral balloon was then inserted and inflated within the undeployed valve, enough to allow for a larger balloon.The undeployed 20mm s3 valve was then implanted in the distal descending aorta.A 2nd 20mm s3 valve was prepped and then deployed in the native annulus without issue.An echo noted a dissection from the stj to the descending aorta.The patient was placed on ecmo and was transferred for post management care.As reported, there was no difficulty inserting the delivery system into the sheath.There was no difficulty with valve alignment or fine adjust.There was no tension noted by the physician or was the system torqued or manipulated.The patient's annulus was mildly calcified and mildly tortuous.The patient's minimum luminal diameter (mld) access vessel measure 6.2mm x 8.2mm.There was mild calcification and no tortuosity of the iliac vessel and measured 4.8mm x 5.1mm.

Manufacturer Narrative

(death and date added) and type of reportable event changed to death upon review of medical records, a coronary occlusion occurred during a planned attempted basilica valve in valve.  the basilica procedure was performed due to low left and right coronary height and high risk for obstruction of right coronary given the patient¿s prosthetic valve type and distance to coronary ostia.The initial 2 passes with basilica wire encountered resistance and were repositioned.Upon repositioning before a third attempt, leaflet perforation was noted and the patient became hypotensive.A posterior effusion was noted on echo with severe aortic insufficiency.Given worsening hemodynamic status a decision was made to quickly replace the aortic valve despite low right coronary in the hopes of achieving better hemodynamic status followed by a pericardiocentesis of the posterior fusion.The 20 mm edwards sapien 3 valve was placed in the body.Prior to balloon positioning the patient became profoundly hypotensive and pulseless and cpr was institiated.The balloon of the edwards delivery system was withdrawn to place the stent valve and the appropriate portion of the balloon as per usual.When examined fluoroscopically; however, it became apparent that the balloon had been pulled back too far and was partially beyond the distal portion of the stent valve.The situation could not be salvaged and the initial delivery system was withdrawn.The valve remained on the wire in the abdominal aorta just distal to sheath.A 8 mm peripheral balloon was placed in the valve and partially deployed it.Subsequently the valve was expanded in the descending aorta with a 18mm balloon to low pressure.A second valve was then prepped and successfully deployed in the aortic annulus under rapid pacing.Pt placed on cardiopulmonary bypass at this time.Aortic angiogram and echocardiogram after deployment of valve showed a good valve replacement with little residual pvl.There was however new inferior st segment elevation on the monitor and the right coronary artery was unable to be visualized and had been occluded by the new valve placement.The artery was able to be wired and ballooned with restoration of flow and decrease in st segment elevation.No stent was placed due to platelet dysfunction.A pericardiocentesis was performed of the anterior portion however it was unclear whether the drain was in the pericardium or pulmonary artery.A posterior drain was placed with resolution of posterior effusion.During the process, the echocardiogram revealed that there was possible aortic dissection and an aortogram was performed, which showed type a dissection extending from just above the annulus throughout the ascending arch and descending aorta and stopping at the level of the first tavr valve that was deployed at the abdominal aorta.A discussion was had with cardiothoracic surgery about converting to an open procedure for repair of the aorta and exploration to assess any areas of ongoing bleeding/perforation.The decision was made however that the patient had a prohibitive risk for emergent cardiothoracic surgery and ought to be transferred to the intensive care unit on mechanical circulatory support in the hopes that she stabilized and would not require any type of surgical exploration given the incredibly high mortality rate that would result.The pericardial drains were sutured in place. the patient received multiple units of red blood cells platelets and ffp throughout the course of the procedure.The patient was transferred to the intensive care unit in critical/grave condition though hemodynamically stable at present on mechanical circulatory support.After discussion with family, the patient was made limited code.The patient went into v tach, was shocked twice with absence of pulse.The patient expired one day post procedure.Per the instructions for use (ifu), coronary flow obstruction is a potential adverse event associated with the tavr procedure.The ifu cautions that the safety and effectiveness have not been established for patients with bulky calcified aortic valve leaflets in close proximity to coronary ostia.Coronary occlusion can result in myocardial ischemia or infarction due to obstruction of the coronary blood flow and may require intervention (e.G.Pci).  there are multiple patient factors that could contribute to coronary occlusion by the prosthetic valve or native valve leaflets, including a minimal distance between the native annulus and the coronary ostia, bulky calcification, long native leaflets, and obliterated coronary sinuses.Procedural factors such as torn native leaflet during bav, plaque shift, deployment of the bioprosthetic heart valve too aortic and significant valve over sizing could also contribute to this complication.The edwards thv training manuals advise the operator on pre-procedure assessment of the aortic valve, root, and coronary anatomy.Physicians are extensively trained by edwards before they are qualified to use the transcatheter heart valve (thv).Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The physician is instructed to evaluate this risk early in the patient screening process in all patients the following factors should be considered: degree of calcification on leaflets, annulus to coronary ostia distance, length of the valve leaflet, width of the valsalva sinuses, movement of the leaflets during bav, patency of coronaries during bav, and expanded height of the intended thv.The training manuals also provide the following tips for detecting risk for left main occlusion: aortogram or tee prior to thv implantation to reveal bulky calcified leaflets; during pre-dilatation, note bulky calcification on valve moving towards ostium on left main; and consider aortogram during valvuloplasty to assess coronary flow.In this case, the cause for the coronary occlusion may be due to patient factors (low left and right coronary height, prosthetic surgical valve type with high risk for occlusion and short distance from surgical valve to coronary ostia) and/or procedural (attempted unsuccessful basilica procedure). there was no allegation or indication a device malfunction contributed to this adverse event.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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 20MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9241969
• MDR Text Key: 166137863
• Report Number: 2015691-2019-03982
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: 9600TFX20A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/31/2019; 07/23/2020
• Supplement Dates FDA Received: 11/20/2019; 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening