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

Model Number 9750TFX26A

Device Problem Particulates (1451)

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

Event Date 04/12/2022

Event Type  malfunction  

Event Description

As reported, upon evaluation of a 26mm ultra sapien valve two small specks were seen.The operators did not implant this valve and a new valve was opened.No patient injury was reported.Additional information indicated that there was no damage to the package or seal, the issue was discovered during rinsing process, the specks were seen inside of the valve on the leaflets.They attempted to rinse the valves to remove the specks and also used small hemostats to try and move the specks.Per pre-decontamination findings, two specks were seen on leaflet #3.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

The returned valve was visually inspected, and the following was observed: two (2) blue particulates were located at the inflow side.Two (2) particulates measured 0.02 in diameter.Imagery evaluation was performed, and the following was observed; two (2) specks observed on the leaflet inflow side.All inspections are conducted on 100% of the units except in the case of product verification testing where units are chosen on a sampling basis.It is possible that a potential manufacturing nonconformance contributed to the reported complaint.A device history record review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the lot history revealed no complaints related to the event device preparation particulate noticed.A complaint history review was performed with the codes device preparation particulate noticed; the complaint occurrence rate did not exceed the applicable trending control limit.The following instructions were reviewed; commander delivery system with s3/s3u and device preparation training manual.No ifu/training deficiencies were identified.A risk assessment was performed on the reported event and revealed no evidence of product non conformances or labeling/ifu inadequacies.The complaint for device preparation particulate noticed was confirmed and a potential nonconformance was identified and assessed; no product risk assessment (pra) escalation is required.A potential manufacturing nonconformance was identified during the investigation.Based on the corrective/preventative actions assessment, a capa is not required, however, at a minimum, as precautionary measures, an awareness communication emphasizing the importance of inprocess mitigation on foreign particulate during manufacturing was performed.The complaint for device preparation particulate noticed was confirmed from the evaluation of the returned valve.A potential manufacturing nonconformance was identified during evaluation.Per material analysis results, the blue particulate showed similar absorption to poly (propylene) material.Process walk through was performed by manufacturing and there were multiple sources of poly (propylene) present in the manufacturing process.Although, during manufacturing process, all sapien 3 ultra valves are 100% visually inspected for particulate, it is possible a potential manufacturing defect contributed to the event.No labeling/ ifu deficiencies were identified during evaluation.As reported, upon evaluation of a 26mm ultra sapien valve, two small specks seen, they decided not to implant and opened a new valve.It is possible that the blue particulates were introduced during device handling/preparation as it was observed during the valve rinsing process or at manufacturing process.As such, available information suggests that improper handling occurred during valve manufacturing (ew manufacturing) or device prepping handling (procedural factors) may have contributed to the complaint event.Based on the assessment of the potential nonconformance; no product risk assessment (pra) escalation is required.A corrective/preventative actions assessment was performed and no capa is required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM
• 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: 14320953
• MDR Text Key: 299797502
• Report Number: 2015691-2022-05613
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)230628
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: 9750TFX26A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2021
• 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: Male