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

Model Number 9600TFX29A

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Device-Device Incompatibility (2919)

Patient Problems Heart Block (4444); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 08/11/2022

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is ongoing.Not returned.

Event Description

As reported by a field clinical specialist (fcs), a patient underwent a transfemoral valve-in-valve tavr procedure with two 29mm sapien 3 valves implanted in the native aortic annulus.During deployment, the team had a possible capture loss of the pacemaker and the valve went ventricular.After assessment using tte and fluoroscopy both, the valve appeared to be 30 aortic/70 ventricular.Concerns about further embolization were discussed and to secure the valve a second 29mm sapien 3 valve was implanted more aortic with success.Post deployment of the second valve, there was no mitral impingement, no paravalvular leak, and the aortic mean gradient was 3 mmhg.The day after the procedure, the patient received a pacemaker, however additional details regarding this event (including if it was a planned procedure or the reason for the pacemaker implant) are not available at this time.Additional information provided by the surgeon to the fcs reported that on the weekend following the tavr procedure, the patient developed a mitral gradient of 15 mmhg and went into flash pulmonary edema.The patient was transferred to a different facility as it appeared per echo that the first s3 valve and possibly the second s3 valve had and/or were both migrating ventricular.The plan was to attempt to explant the valves, but there were complications and the patient expired during the procedure.The physician stated that the mechanical mitral valve was fine and functioning once the aortic valves were removed, however, there were complications removing the aortic valves and thus the patient did not make it.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections b4, g3, g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned to edwards lifesciences for evaluation.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this event is not required at this time.The complaints for malpositioned thv, thv migrated, and interventional device interacts with pre-existing implantable device were unable to be confirmed as no imagery/medical records were provided.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.Valve deployment and position - malpositioned thv as reported, -upon the initial implant for the first valve, the team had a possible capture loss of the pacemaker and the valve went ventricular.After assessment using tte and fluoroscopy both, the valve appeared to be 30 aortic/70 ventricular-.Per the instructions for use (ifu), valve malposition requiring intervention is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.During procedure, rapid pacing is performed to provide transient reduced cardiac output to facilitate balloon stability during valve deployment.In this case, the loss of pacing capture likely disrupted the balloon stability during deployment, causing the thv to land too low within the ventricle.As such, available information suggests that procedural factors (loss of pacing capture) may have contributed to the complaint event.Post implantation - thv- migrated and valve deployment and position - interventional device interacts with pre-existing implantable device as reported, -the weekend following the tavr, the patient developed a mitral gradient of 15 and went into flash pulmonary edema.The patient was transferred to a different facility as it appeared per echo that the first s3u and possibly the second s3u had and/or were both migrating ventricular.- additional information received clarified that -both of the aortic valves were migrating south, likely causing the conduction disturbance.- per the instructions for use (ifu), valve migration requiring intervention is a known potential adverse event associated with transcatheter valve replacement procedure.In this case, due to the low seated thv, it is likely that the forces acting on the thv overcame the strength of attachment between the valve structure and target site, resulting in valve migration and interactions with pre-existing mitral valve implant.As such, available information suggests that procedural factors (malpositioned thv) may have contributed to the complaint event.Heart block per the instructions for use (ifu, conduction system defects (heart block) which may require a permanent pacemaker are potential adverse events associated with balloon aortic valvuloplasty, deployment of the prosthetic valve, and the overall tavr procedure.According to the valve academic research consortium (varc) guidelines, the close anatomical relationship between the aortic valve complex and the branching atrioventricular bundle may provide an explanation for these complications of the tavr procedure.According to literature review, and as documented in a technical summary written by edwards lifesciences, atrioventricular conduction disturbances after tavr are associated with many patient related and procedural related factors, including preoperative comorbid status, the degree and bulkiness of aortic valve and annular calcification, interventricular septal thickness, preexisting electrocardiogram abnormalities, the depth of prosthesis implantation, and the profile of the implanted prosthesis.Unlike conventional avr, where there may be localized trauma due to decalcification of the annulus and/or suture placement in the proximity of the av node or the bundles, tavr may cause conduction abnormalities through mechanical impingement of the conduction system by the prosthesis.The mechanisms of the development of heart block after tavr are well documented and described in the literature.It is also documented that pre-existing heart block is common in patients undergoing tavr or surgical avr and another 4 to 6 % will develop postoperative heart block, potentially requiring a permanent pacemaker.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Patient factors not provided and/or the mechanisms described above are likely contributing factors for the 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.A definitive root cause is unable to be determined.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor pra is required at this time.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15513954
• MDR Text Key: 300891662
• Report Number: 2015691-2022-08190
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)250125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death
• Patient Sex: Male