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

Model Number 9600TFX26A

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2020

Event Type  Injury  

Event Description

Edwards reviewed the article "optimal imaging guidance during transcatheter mitral valve-in-valve replacement in bioprostheses with radiolucent sewing rings".As reported through our united states affiliate per a literature article: "optimal imaging guidance during transcatheter mitral valve-in-valve replacement in bioprostheses with radiolucent sewing rings".This study consisted of two cases of transcatheter mitral valve replacement (tmvr) in the presence of a radiolucent seeing ring and highlights the imaging consideration in obtaining a satisfactory valve position.Of the two patients identified for this study, only one patient required intervention.Approximately 4 years post-implant of that patient who had a history of mitral valve replacement, the patient's transesophageal echocardiogram (tee) showed severe mitral regurgitation due to a failed leaflet of a 29mm mosaic valve and was treated with a 26mm sapien 3 valve via transseptal approach.During implantation, the ventricular edge was placed below the ventricular edge of the markers and the valve was not above the sewing ring.Although slow inflation was used to allow for adjustments for positioning, the valve slipped ventricularly.Under fluoroscopy, post-deployment showed a malpositioned valve.A 2nd 26mm sapien 3 valve was implanted and there was trace mr with no lvot obstruction.The patient's post-procedure recovery was uncomplicated, and the patient remains well at the 4-month follow-up, with stable hemodynamics.

Manufacturer Narrative

The investigation is ongoing.Gong, fei fei, andrew c.Peters, s.Chris malaisrie, charles j.Davidson, james d.Flaherty, david j.Mehlman, akhil narang, and jyothy j.Puthumana."optimal imaging guidance during transcatheter mitral valve-in-valve replacement in bioprostheses with radiolucent sewing rings." case reports 2, no.8 (2020): 1129-1134.H3 other text : valve not returned for examination.

Manufacturer Narrative

Correction to h6; type of investigation, investigation findings, investigation conclusion.The 26mm sapien 3 valve was not returned for evaluation as the valve remains in the patient.Without the device returned for evaluation, visual inspection, functional testing, and dimensional analysis were unable to be completed.Imagery provided in the journal article indicated that prior to thv deployment, valve outflow appeared to be positioned too low in reference to the radiopaque markers associated with the outflow edge of the surgical valve, the final position of the deployed thv valve appeared to be too ventricular.Per the event details, transcatheter mitral valve replacement (tmvr) was performed within pre-existing mitral valve using a sapien 3 thv with an unspecified delivery system or implant date provided.Based on this limited information, this section covers the ifu revision for a sapien 3 thv with a commander delivery system which was in circulation prior to the manuscript acceptance date of (b)(6) 2020 (assuming that the procedure would have been performed prior to this date).The general ifu guidelines including all the warning statements, precautions, adverse events, and procedural steps do not appreciably change across different ifu revisions.In addition, the reviewed content is generally applicable irrespective of the delivery system/access approach used.Based on this review, no ifu/training deficiencies were identified.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 the failure mode is not required at this time.The complaint for a malpositioned valve was confirmed based on provided imagery in the article.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.As reported in the article, "during the tmvr procedure using a 26mm sapient 3 valve via transseptal approach, the valve was positioned, and the ventricular edge fell just below the ventricular edge of the markers.Using a tee, the sapien valve was observed to not be adequately above the sewing ring or that the ventricle edge was below the stent post.The operators used slow inflation to allow for adjustment, but the valve slipped more ventricular".Valve malposition requiring intervention is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.In this, case patient had a pre-existing surgical valve with radiopaque outflow markers.Per the mitral valve-in-valve procedural manual, the outflow of crimped s3 thv should be aligned 2 mm below the surgical valve outflow markers prior to deployment.Based on the imagery included in the article, the initial position of the thv was too low, causing the valve to land too ventricular.In this case, available information suggests that procedural factors (valve positioning technique) may have contributed to the complaint event.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 16010885
• MDR Text Key: 305780939
• Report Number: 2015691-2022-10143
• Device Sequence Number: 1
• Product Code: NPU
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

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 Model Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 61 YR
• Patient Sex: Male