MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN TRANSCATHETER HEART VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number VALVE UNKNOWN

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Endocarditis (1834); Failure of Implant (1924); Injury (2348); No Code Available (3191)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

This is one of four manufacturer reports being submitted for this case, to report valve embolizations.The date of the events is unknown.According to the article the date range for these events are from 2014-2018.For this reason, the first day of the range was used as the occurrence date ((b)(6) 2014).In this case, the exact valve model number is not available, as it could be a sapien xt or a sapien 3.Therefore, this report will reflect an unknown edwards sapien transcatheter heart valve.The possible pma numbers associated with an edwards sapien transcatheter heart valve are listed below; the pma/510k # of this report will remain blank.P130009 - edwards sapien xt¿ transcatheter heart valve; p140031- edwards sapien 3 transcatheter heart valve with commander delivery system.Investigation is ongoing.

Event Description

As through the review of the pics-aics 2019 presentation ¿procedural and short-term outcomes of sapien valve transcatheter pulmonary valve replacement in the native or patched right ventricular outflow tract¿ an international multi-center retrospective study was performed of 280 patients who underwent tpvr with a sapien xt (53 patients) or sapien 3 valve (227 patients) in a native or patched rvot from 2014-2018.The following complications occurred during the study period: twelve cases of tricuspid valve injury, nine cases of valve embolization, two cases of coronary/aortic compression, and six cases of endocarditis (median of 1.2 years).Surgical interventions resulting from complications included tricuspid valve repair in five patients and pulmonary valve replacement in six (two valve embolization, two aortic/coronary compression, one primary valve failure, one endocarditis).There was no procedural mortality.In this international multicenter study, sapien valve placement in the native or patched rvot was found to be feasible with good hemodynamic outcomes and acceptable medium-term outcomes.

Manufacturer Narrative

This is one of four manufacturer reports being submitted for this case. please reference related manufacturer report no: 2015691-2019-03824, 2015691-2019-03826, 2015691-2019-03827.  it is to be noted that the exact valve model number for each event was not provided by the authors.The sapien xt valve is indicated for pulmonic use in pediatric and adult patients.The edwards sapien 3 thv is currently under investigation in the united states for pulmonic application.Per the pulmonic ifu, the edwards commander delivery system and accessories are indicated for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions: dysfunctional rvot conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention, and: regurgitation = moderate regurgitation, and/or stenosis: mean rvot gradient = 35 mmhg.Per the instructions for use (ifu), device embolization is a known potential complication associated with the transcatheter pulmonic valve replacement (tpvr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve embolization, including, but not limited to, improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, rapid deployment, movement of the delivery system by the operator, valve size mismatch, suboptimal implant location, and incomplete frame expansion.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien xt and sapien 3 thv.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor to the placement and fixation of the device.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.In this case, there was no allegation or indication a product deficiency contributed to these adverse events.  based on the limited information available, the cause of the valve embolization in two patients is unknown.However, patient and procedural factors not provided may have contributed to the events.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.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9200588
• MDR Text Key: 165053890
• Report Number: 2015691-2019-03825
• Device Sequence Number: 1
• Product Code: NPV
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VALVE UNKNOWN
• 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