MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER, 29MM; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Death (1802); Mitral Regurgitation (1964); Therapeutic Response, Decreased (2271); Injury (2348)

Event Date 09/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Thv/tvt registry.The investigation is ongoing.This is two of two manufacturer reports being submitted for this case.This report represents the second valve used in the case.Please reference related manufacturer report no: 2015691-2018-04192.

Event Description

Approximately 4 to 5 hours post implant of a 29mm sapien 3 valve in the native mitral position, the mitral regurgitation for the patient was getting worse and tte showed the valve was migrating into the atrium and rocking.The patient was brought back into the or and a second 29mm sapien 3 valve was implanted deeper into the lvot to secure the first valve.Later the same day post procedure, the second valve also migrated a few millimeters toward the atrium.The patient expired 4 days post procedure.The cause of death is unknown at this time.The valve was deployed with nominal inflation volume.There is no evidence or allegation an edwards device malfunction caused the event.

Manufacturer Narrative

The edwards sapien 3 transcatheter heart valve is indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 8% at 30 days, based on the sts risk score and other clinical co-morbidities unmeasured by the sts risk calculator).Deployment of the sapien 3 valve in a native mitral valve is not indicated per the labeling; therefore the labeling (ifus and ew training manuals) do not instruct the operator how to position the sapien 3 valve in this scenario.Per the instructions for use (ifu), valve migration is a potential risk associated with the use of the valve.According to literature review, valve migration results when forces acting on the transcatheter heart valve (thv) overcome the strength of attachment of the valve to the landing zone.Less-than-severe and non-uniformly distributed calcification, incorrect valve sizing, and incomplete frame expansion, and can contribute to valve migration.Malposition is another risk factor for migration and regurgitation.If the valve is deployed too atrial, it may not cover the native mitral valve.As a result, the native mitral leaflet deflected flow, creating a venturi effect where a reduction in blood pressure resulting in mitral regurgitation.In this case, the device is not available for evaluation as it remains implanted in the patient.However, there was no allegation or indication a device malfunction contributed to this adverse event.The cause of the valve migration could not be determined with the limited available information.Despite multiple investigational attempts, it was not possible to obtain additional details regarding the events or the cause of death.The facility declined edwards request for additional information.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, 29MM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7963206
• MDR Text Key: 123669462
• Report Number: 2015691-2018-04193
• Device Sequence Number: 1
• Product Code: NPU
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2020
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR