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

Model Number 9750CM23A

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted when additional information is provided.

Event Description

As reported by the field clinical specialist, during a transfemoral tavr procedure with a 23mm sapien 3 ultra valve in the aortic position, during deployment the physician had great difficulty emptying the syringe.The inflation was slow and required excess force.The valve deployed without issue or problems.Per additional information provided, it took the physician approximately twice as long to empty the syringe, almost like there was something obstructing the flow of contrast.The approximate time of inflation/deflation was 20 seconds.After valve implant the commander delivery system was removed without issues.Upon removal, the fcs tested the delivery system on the back table and there was no difficulty inflating the balloon.The perceived root cause for the inflation/deflation difficulty was the collapsed balloon lumen while inside the body.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections g6, h2, h6: component code, type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned, and no imagery was provided for evaluation.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 the unavailability of the complaint device and /or applicable imagery.Therefore, a manufacturing non-conformance was unable to be determined.A review of lot history and device history record revealed no indication that a manufacturing non-conformance contributed to the event.As reported, "the valve was deployed with great difficulty in the body, it took the physician approximately twice as long to empty the syringe, almost like there was something obstructing the flow of contrast.The pacing run lasted twice as long as normal and while the valve deployed in the correct position and height, the physician was very concerned about how hard it was to empty the syringe during the deployment.Following the procedure, after valve implant and commander was removed, i tested the system on the back table.There was no difficulty inflating the balloon, the perceived root cause for the inflation/deflation difficulty was the collapsed balloon lumen while inside the body." it is possible that due to patient anatomy or procedural factors the guidewire lumen was kinked before valve deployment, leading to the reported constriction and subsequent inflation difficulties.However, without patient/procedural imagery or the returned complaint device, a definite root cause is unable to be determined.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.Therefore, no corrective or preventative action nor product risk assessment escalation is required at this time.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15611214
• MDR Text Key: 302061268
• Report Number: 2015691-2022-08617
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)240421(10)64345768
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM23A
• Device Catalogue Number: 9750CM23A
• Device Lot Number: 64345768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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 Sex: Female