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

Model Number 9600TFX23J

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is pending.

Event Description

In this case, engineering pre-decontamination evaluation observed a liner tear on the returned sheath, and four (4) bent struts on the outflow side of the sapien 3 valve.There was report of integrity loss to the esheath.The devices were exchanged out and procedure was completed with no injury to the patient.

Manufacturer Narrative

The following report fields have been updated due to a correction with information received: g3.

Manufacturer Narrative

The edwards sapien 3 transcatheter heart valve was returned for evaluation.The condition of the returned valve was crimped on the crimp balloon, and delivery system inserted partially through sheath.The crimped valve exposed through the torn liner.The returned devices were evaluated, and the following observations were made: four (4) struts were bent in and out at outflow.Post-expanded valve had bent struts corrected.Frame was distorted/canted.Leaflets wrinkled and dehydrated due to storage condition (prolong crimping) during the return handling process.There were gouges on the flex tip.No imagery was provided for review.A review of the device history record (dhr) did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.As the returned device meets specification with no evidence to support a manufacturing/design defect has contributed to the complaint, a manufacturing mitigation review is not required.The instructions for use (ifu)/labeling training were reviewed for the sapien 3 with commander delivery system, japan, edwards sapien 3 transcatheter heart valve with the edwards commander system - device preparation manual and procedural training manual.Per precautions/warnings: do not allow the thv to come in contact with the bottom or sides of the rinse bowl during swirling of the thv.Care must be taken to ensure that the identification tag does not come in contact with and damage the leaflets.No other objects should be placed in the rinse bowls.Throughout the procedure, intermittently flush the expandable sheath with heparinized saline from the flush port.The thv should not be advanced through the sheath if the sheath tip is not past the aortic bifurcation.To prevent possible leaflet damage, the thv should not remain in the sheath for over 5 minutes.No ifu/training deficiencies were identified.There were no product non-conformances or ifu/training manual deficiencies identified, therefore no escalation to a product risk assessment (pra) was required.Since no edwards defect was identified, no corrective or preventative actions are required.The complaint for "general risks - failure - frame damage" was confirmed.No potential manufacturing non-conformance were identified.Review of the dhr and lot history review did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.As reported, "there was much resistance than usual when a commander delivery system was passing an esheath.The delivery system could not pass through the sheath, and it got bent while pushing into the sheath".Per the case note, patient had moderate calcification and tortuosity.Procedural training manual states, "push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification".Presence of tortuosity and calcification in vasculature can create a challenging pathway during the delivery system insertion through sheath, it can lead to high push force and resistance.The gouges on flex tip indicates the excessive device manipulation.So, if the excessive force is applied to overcome the resistance and manipulate the delivery system, it can lead to flex tip interact with the outflow struts and results in bent struts.As such, available information suggests patient (calcification/tortuosity) and/or procedural (excessive device manipulation) factors may have contributed to the reported event.The complaint for "general risks - failure - frame damage" was confirmed.No manufacturing issue was identified during evaluation.Available information suggests that patient (calcification/tortuosity) and/or procedural factors (excessive device manipulation) may have contributed to the complaint event.No labeling or ifu/training inadequacies were identified.Therefore, no corrective or preventative action nor pra is required at this time.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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

• 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: 12870681
• MDR Text Key: 283252097
• Report Number: 2015691-2021-06518
• Device Sequence Number: 1
• Product Code: NPT
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2023
• Device Model Number: 9600TFX23J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2021
• 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 Age: 84 YR
• Patient Sex: Male