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

Model Number 9600TFX26

Device Problem Positioning Problem (3009)

Patient Problem Pulmonary Regurgitation (2023)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

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), valve malposition is a known potential complication associated with the use of the transcatheter heart valve (thv).There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve malposition, including, but not limited to, incorrect sizing of the landing area, improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, rapid deployment and movement of the delivery system by the operator.In this case, there was no allegation or indication a product deficiency malfunction contributed to this adverse event.  investigation results suggest/indicate procedural factors (valve positioning prior deployment, placement of s3 valve in a borderline size native pulmonic valve) likely contributed to the too pulmonic position of the initial sapien 3 valve and subsequent deployment of a second valve.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.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 affiliate in (b)(6), regarding a 26mm sapien 3 valve into a failed surgical valve, in pulmonic position by transfemoral approach.As reported, the surgical valve as very thickened and difficult to cross with the common, fairly acute angle from the rvot to the pulmonary artery.As a result, it was very difficult to position the delivery system perfectly parallel to the long axis of the prosthesis before deployment.Usually, a very slow balloon inflation allows for some adjustment of positioning and often re-orients the valve favorably before final balloon inflation.In this case, however, the sapien 3 valve position could not be adjusted as it had caught, or stuck to, the old thickening prosthesis.With the final balloon inflation, the valve did not re-orient in the prosthesis, so the ¿inside¿ of the curve delivered the s3 too distal in the prosthesis.There was no portion of the stent below the prosthetic valve ring (>100/0).The operator was not satisfied that this position was sufficiently stable/secure to leave it alone, therefore, a second valve was necessary.There was mild-moderate pvl around the sapien 3 within the surgical valve due to the high position.Second valve (a new 26mm sapien 3) was deployed without any difficulty, placing it slightly lower than ¿standard¿, to ensure complete overlap with the old prosthesis.The result was excellent.Patient discharged in stable condition. no other procedural complications were experienced.No further info is available.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 10690972
• MDR Text Key: 211909459
• Report Number: 2015691-2020-13995
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2022
• Device Model Number: 9600TFX26
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2020
• Date Device Manufactured: 03/23/2020
• 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: 26 YR