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

Model Number 9600TFX29

Device Problem Contamination (1120)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is underway.

Event Description

As reported by an edwards lifesciences affiliate in (b)(6), during prep of a 29 mm sapien 3 valve in the aortic position via transfemoral approach dirt was observed on one of the valve leaflets.The valve was rinsed; however the dirt was unable to be removed.The device was discarded and not used in the procedure.The valve was exchanged, and a different 29 mm sapien 3 valve was successfully implanted.The patient was doing well post procedure.

Manufacturer Narrative

The product was not returned for evaluation.Imagery provided by the site confirmed two black particulates present on one of the leaflets.As the device was not returned no functional or dimensional testing was able to be performed.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed no other similar complaints.The instructions for use (ifu), device preparation and the training manual were reviewed for instructions or guidance for proper use of the device and no deficiencies were identified.During the manufacturing process, the valve is visually inspected and tested several times.During manufacturing the valve leaflets were 100% inspected.During the final inspection, the valve underwent 100% inspection by both manufacturing and quality.100% visual inspected is performed on the valve and the jar lid for foreign particulates.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported event.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.The complaint for device preparation particulate noticed was confirmed from the provided imagery.A review of dhr, lot history, complaint history, and manufacturing mitigations did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.Additionally, during manufacturing process, all sapien 3 valves are 100% visually inspected for particulate.Therefore, it is highly unlikely that a manufacturing defect contributed to the event.No labeling ifu deficiencies were identified during evaluation.Due to the unavailability of the device, no further testing could be conducted.There is insufficient information to determine a root cause at this time.The complaint event was confirmed via imagery provided by the site.No manufacturing nonconformances contributed to the reported event.No labeling ifu training inadequacies were identified.Complaints 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.As such, neither a product risk assessment escalation, nor corrective or preventative actions are required.

• 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
• MDR Report Key: 11355109
• MDR Text Key: 234295814
• Report Number: 2015691-2021-01359
• Device Sequence Number: 1
• Product Code: NPT
• 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
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1