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

Model Number 9600TFX29A

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

The date of the event is unknown; however, according to the article the study period was from may 2018 to april 2021.For this reason, the first day of the reported study period (01-may 2018) was used as the occurrence date.Article citation: carr, k., nijres, b.M., windsor, j.J., nakamura, y., karimi, m., ricci, m., & aldoss, o.(2022).Single center experience of hybrid pulmonary valve replacement using left anterior thoracotomy with pulmonary artery plication in patients with large right ventricular outflow tract.Journal of the american heart association, 11(14), e026517.The investigation is in progress.A supplemental report will be submitted when additional information is provided.

Event Description

As reported through the article, "single-center experience of hybrid pulmonary valve replacement using left anterior thoracotomy with pulmonary artery plication in patients with large right ventricular outflow tract" carr, k.Et al.2022, a single-center, retrospective review of patients undergoing a transcatheter pulmonary valve replacement (tpvr) was performed.The study included a total of 11 patients that presented for hybrid tpvr between may 2018 and april 2021.Nine out of 11 patients received a tpvr after main pulmonary artery plication.There were no procedurally related deaths.A well-functioning pulmonary valve was observed in all patients at the last follow-up.Per the authors, during the study period a major complication occurred in only 1 patient (11.1%) after a transvenous tpvr procedure with a 29mm sapien 3 valve.The deployed valve became malpositioned and then failed transcatheter repositioning attempts.This patient underwent a successful surgical removal of the sapien 3 valve and then operative implantation of a bioprosthetic medtronic bioprosthetic valve.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation and medical record review findings.Sections g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned, and no image evaluation was performed as no imagery was provided.As no device was returned, engineering was unable to perform visual inspection, functional testing, or dimensional testing.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 this adverse event is not required at this time.The complaint was unable to be confirmed due to unavailability of procedural imagery.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.As reported, the deployed valve became malpositioned during implant and then failed transcatheter repositioning attempts.Due to insufficient information, a definitive root cause was unable to be determined at this time.Per the instructions for use (ifu), device malposition requiring intervention is a potential adverse event associated with the transcatheter pulmonic valve replacement procedure.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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no labeling or ifu inadequacies were identified, no corrective/preventative action nor product risk assessment escalation is required.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, PULMONIC VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15506323
• MDR Text Key: 300875318
• Report Number: 2015691-2022-08150
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention