MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX23A

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported in an article, 'equipment entrapment during redo-tavr with successful basilica procedure', transcatheter aortic valve replacement (tavr) has emerged as a promising therapy for failed bioprosthetic surgical aortic valves.Coronary obstruction, a rare but devastating complication of viv implantation, with a short-term mortality rate of 40%, may occur in 40% of the patients.Due to this concern, an innovative method has been devised by jaffar et al that involves bioprosthetic aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (basilica) using electrocautery.We present a case of early failure of a self-expanding non-edwards thv due to accelerated calcification.As reported, 3 years post implant of a non-edwards tavr valve in the aortic position, the patient presented with severe hypoxemia and was found to have congestive heart failure.The patient was treated and discharged.The patient presented a month later with pulmonary edema.Her condition improved following diuresis and was discharged back to snf after 3 days.The patient presented a week later with recurrent pulmonary edema that required intubation.Her condition stabilized after 10 days of hospitalization and she was evaluated by the heart team and was deemed at extreme risk for surgical valve replacement.The decision was made to proceed with urgent transcatheter valve in valve (viv) implantation.Due to risk of coronary occlusion, a basilica of the left non-edwards valve leaflet with percutaneous axillary tavr and additional coronary protection with provisional stent placement was performed.During the 23mm sapien 3 ultra valve deployment, the valve moved towards a more aortic position.Both guide catheters were found to be severely entrapped between the non-edwards (outer valve) and the sapien 3 ultra valve (inner valve) frames.Despite considerable traction, raising concern for catheter fracture, the catheters could not be removed.A noncompliant balloon was advanced into the trapped part of the guidecatheter and inflated in an attempt to displace the sapien 3 ultra valve frame, but this proved unsuccessful.The balloon was then advanced such that it was protruding from the tip of the catheter and inflated to create a distal bulb.Concurrent traction on the guidecatheter as well as the balloon (providing traction from the distal end) led to successful retrieval of the entrapped catheter.Transesophageal echocardiography showed trace paravalvular regurgitation with good position of the valve.The delivery sheath was removed after inflation of a balloon in the subclavian artery to achieve 'dry closure'.The patient returned to the intensive care unit and was extubated the following day.The patient was commenced on anticoagulation and, after diuresis, was discharged back to the snf on the third day.The patient returned to the clinic 1 month later reporting marked improvement in her exercise tolerance and dyspnea.Both valves remain implanted in the patient.

Manufacturer Narrative

A negative device interaction and difficulty or inability to withdraw system from the deployed valve was reported in the article, 'equipment entrapment during redo-tavr with successful basilica procedure' the device was not returned for evaluation; however, there was no allegation or indication of an edwards device malfunction.Imagery was provided in the article.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.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.In this case, the event appears to be related to patient factors (significant effacement of the sinus of valsalva with a low sinotubular junction height) and procedural factors (device manipulation).There is insufficient information to determine if a relationship existed between the entrapped interventional guide between the pre-existing surgical valve and the newly implanted thv valve.Other potential contributing factors are unknown as limited clinical information was provided.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.Reference for article: waqas qureshi, matthew parker, jennifer walker, nikolaos kakouros (2021), equipment entrapment during redo-tavr with successful basilica procedure.Catheterization and cardiovascular interventions scai.Https://doi.Org/10.1002/ccd.29485.

• Brand Name: EDWARDS SAPIEN 3 ULTRA VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11462800
• MDR Text Key: 241101113
• Report Number: 2015691-2021-01784
• 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
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX23A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR