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

Model Number 9600TFX29

Device Problems Leak/Splash (1354); Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problems Hemolysis (1886); Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

The edwards sapien 3 ultra transcatheter heart valve system is 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 to be appropriate for the transcatheter heart valve replacement therapy.2) the edwards sapien 3 ultra transcatheter heart valve system 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).The device was not available for evaluation, as it remains implanted in the patient and no imagery was provided.Per the cer, the device was used in an off-label implantation in a surgical ring.As there are no specific ifu or training materials related to tvr in a ring procedure, the available training materials were reviewed only for information potentially relevant to the device use.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.Paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (tvr) procedure.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.In this case, there was no indication a product deficiency contributed to this adverse event.The exact cause of the reported event was unable to be determined, but may have been due to patient and/or procedural factors listed above.There was no allegation or indication that these adverse events were related to a device malfunction.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

As reported by an edwards lifesciences affiliate in (b)(6), a 29 mm sapien 3 valve was implanted in the mitral position via transfemoral approach into a pre-existing edwards physio ring.Post implant paravalvular leak was observed between the valve and the ring due to the valve being placed too atrial.The leak resulted in hemolysis.A second 29 mm sapien 3 valve was prepped and implanted valve in valve (viv).The paravalvular leak and hemolysis both were resolved.The patient was doing well post procedure.

Manufacturer Narrative

Correction: f10 device code changed from regurgitation 1250 to paravalvular regurgitation 1457.Additional information: b5: additional information provided from the site clarified the regurgitation was paravalvular regurgitation.H10: additional information added to h10 narrative.Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.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 reported event placement too atrial due to patient and/or procedural factors resulted in a paravalvular leak.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

Additional information provided from the site clarified the regurgitation was paravalvular regurgitation.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10253265
• MDR Text Key: 200006167
• Report Number: 2015691-2020-12455
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29
• 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): Required Intervention
• Patient Age: 71 YR