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

Model Number 9750TFX26

Device Problem Malposition of Device (2616)

Patient Problem Cardiac Arrest (1762)

Event Date 02/06/2023

Event Type  Injury  

Event Description

As reported from our affiliates in brazil, this was a case of a 26mm sapien 3 ultra valve in aortic position by transfemoral approach.During device preparation, the 26mm sapien 3 ultra was mistakenly crimped in the inverted position.The system and crimped valve were reviewed before introducing into the patient as per protocol.The 26mm sapien 3 ultra valve was implanted and patient had cardiorespiratory arrest until the crimping error was detected.A new 26mm valve was correctly prepared and implanted in the patient.The patient left the room hemodynamically unstable and remained in serious condition in the intensive care unit (icu) using vasoactive drugs and mechanical ventilation.Per follow up, the patient was conscious, oriented, without neurological damage, and on spontaneous ventilation.The patient was discharged without sequelae from the event after a prolonged icu stay post-procedure due to pneumonia that arose during hospitalization.Per medical opinion, the root cause of the event was human error.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

Updated h6-type of investigation, investigation findings, investigation conclusions.The device was not returned for evaluation.The complaint for implantation of incorrectly oriented valve was unable to be confirmed.The reported event does not allege a device malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are an anticipated risk of the transcatheter heart valve (thv) procedure, additional assessment of the failure modes is not required at this time.As reported, "during device preparation, the 26mm sapien 3 ultra was mistakenly crimped in the inverted position.The system and crimped valve were reviewed before introducing into the patient as per protocol.The 26mm sapien 3 ultra valve was implanted and patient had cardiorespiratory arrest until the crimping error was detected." device preparation and procedure training manual instructs to verify thv orientation prior to inserting the delivery system into the sheath.In this case, both the hospital tech, who crimped the valve, and the operating physician failed to identify that the valve was crimped in incorrect orientation.As such, available information suggests that procedural factors (failure to identify incorrect orientation of the valve) may have contributed to the complaint event.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.No corrective or preventative actions are required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16449137
• MDR Text Key: 310318184
• Report Number: 2015691-2023-11130
• 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
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2024
• Device Model Number: 9750TFX26
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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 Outcome(s): Required Intervention