MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SAPIEN M3 VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9680TFX29M

Device Problems Calcified (1077); Degraded (1153)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 12/17/2019

Event Type  Death  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by the m3 clinical trial, approximately 1 year and 3 months post procedure, echo showed severe mitral stenosis.The peak mitral velocity was 2.43 m/s, and peak gradient was 23.7mmhg and mean gradient was 14.2 mmhg.No action was taken.The patient required hospitalization or prolongation of existing hospitalization.The outcome was not recovered/not resolved.

Manufacturer Narrative

Additional information was received.Section h1 was corrected.Approximately 1 year and 5 months post procedure, the patient expired at home due to heart failure/chf/low output failure/hypotension.

Manufacturer Narrative

Additional information was received.Per the patient¿s family, the patient was found unresponsive in the bathroom and pronounced dead at home.Death certificate declared cause of death as atherosclerotic cardiovascular disease.The relationship to the study device, sapien m3, was considered to be not related.

Manufacturer Narrative

Per the instruction for use (ifu), valve stenosis is a potential risk associated with bioprosthetic heart valves.Per the valve academic research consortium (varc), valve stenosis can result from a number of factors, including pannus, calcification, support structure deformation (out-of-round configuration), trauma (cardio-pulmonary resuscitation, blunt chest trauma), endocarditis, prosthetic valve thrombosis, and native leaflet prolapse impeding prosthetic leaflet motion.Stenosis of an implanted valve may also be a manifestation of structural valve deterioration (svd).This term refers to changes intrinsic to the valve, and can include failure modes such as wear, calcification, leaflet tear, stent creep, leaflet disruption, or leaflet retraction.There are cases of svd that result in a combination of regurgitation and stenosis.It may be mild and not require any intervention or it may be moderate to severe.In these cases, it causes the heart to work harder to eject blood from the ventricle.Depending on severity it could be an indication for valve replacement or medical intervention.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Despite multiple requests, additional information was unable to be obtained.The cause for the valve stenosis could not be confirmed.However, pre-existing valvular disease progression and patient factors not provided may be contributing factors.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: SAPIEN M3 VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9572434
• MDR Text Key: 175252588
• Report Number: 2015691-2020-10119
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2019
• Device Model Number: 9680TFX29M
• 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): Hospitalization