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

Model Number SAPIEN VALVE UNKNOWN

Device Problems Perivalvular Leak (1457); Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Regurgitation (1964)

Event Date 04/01/2015

Event Type  Injury  

Manufacturer Narrative

The dates of the events are unknown; however, according to the article the study period was from april 2015 to april 2019.For this reason, the first day of the reported study period ((b)(6) 2015) was used as the occurrence date.It was unknown which valve the patient¿s received, sapien xt or sapien 3 valves.The pma numbers are p130009 for sapien xt and p140031 for sapien 3.Article reference: morris mf, pena jr a, kalya a, sawant a, lotun k, byrne t, fang hk, pershad a, predicting paravalvular leak after transcatheter mitral valve replacement using commercially available software modeling, journal of cardiovascular computed tomograph, https://doi.Org/10.1016/j.Jcct.2020.04.007.The edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 3% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical co-morbidities unmeasured by the sts risk calculator).The edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are 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).Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves.The patient screening manual and the procedure didactic identify several procedural and anatomical factors which could contribute to pvl, including device malposition, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, an elliptical annulus shape and valve under-sizing.Physicians are extensively trained by edwards before they are qualified to use the sapien thv.The patient screening manual instructs the operator on proper aortic valve and root assessment, including the use of echo, aortogram and ct to appropriately measure the annulus diameter, content and distribution of calcium, and leaflet characteristics.Contraindications, important considerations when assessing the valve, and choosing the proper thv are also discussed.The thv training manuals also instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures are also included.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The cause for the pvl and annular dehiscence could not be confirmed with the information provided by the authors.However, 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.No corrective or preventative actions are required.

Event Description

Per the literature article, ¿predicting paravalvular leak after transcatheter mitral valve replacement using commercially available software modeling¿, during the study period, 4/2015 through 4/2019, 58 consecutive patients underwent tmvr at two institutions with a sapien xt or sapien 3 valve.Moderate or severe mitral regurgitation (mr) developed in 12 patients after tmvr due to paravalvular leak (pvl).Two patients had both moderate pvl and moderate central mr, two patients had inadvertent atrial positioning of the valve during deployment, and one patient with vir had annular dehiscence after tmvr.In patients that developed moderate or severe pvl, 6 were vimac, 5 vir, and 1 viv.To treat the patients with moderate or severe pvl, 6 had a plug implanted, 3 had a second sapien valve implanted, 2 had balloon post dilatation, and 1 had surgical mitral valve replacement, with reduction in pvl to mild or less at the conclusion of the procedure or on tte prior to hospital discharge.

Manufacturer Narrative

This is one of four manufacturer reports being submitted for this case.Please reference related manufacturer report numbers: 2015691-2020-12155, 2015691-2020-12151, 2015691-2020-12153, 2015691-2020-12154.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SAPIEN VALVE UNKNOWN
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10149210
• MDR Text Key: 196478256
• Report Number: 2015691-2020-12153
• 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
• Report Date: 05/20/2020

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: SAPIEN VALVE UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 06/12/2020; 07/23/2020
• Supplement Dates FDA Received: 06/12/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention