MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SAPIEN 3 PULMONIC DELIVERY SYSTEM; PULMONARY VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9630PL29A
Medical Device Problem Codes	Inflation Problem (1310); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field clinical specialist (fcs), during a transfemoral tpvr procedure with a 29mm sapien valve in an alterra present, the team was unable to deploy the sapien 3 valve due to the patient's tortuous anatomy and kinking of the pulmonic delivery system valve housing.Upon removal, the valve was observed to be damaged due to anatomical turns from the right ventricle to the pulmonary artery.Per report, the alterra prestent system was deployed as planned.The case was aborted.
Additional Manufacturer Narrative
Investigation is still ongoing.
Additional Manufacturer Narrative
It was initially reported by the field clinical specialist (fcs), that during a transfemoral tpvr procedure with a 29mm sapien valve in an alterra present, the team was unable to deploy the sapien 3 valve due to the patient's tortuous anatomy and kinking of the pulmonic delivery system valve housing.Upon removal, the valve was observed to be damaged due to anatomical turns from the right ventricle to the pulmonary artery.Per report, the alterra prestent system was deployed as planned, and the 29mm sapien 3 valve was not implanted.The case was aborted.Per follow up received, it was reported that inflation was not attempted during the procedure as it was initially perceived to have been the issue.As there was no inflation issue, and based on re-assessment from the additional information received, this complaint is no longer considered to be a reportable event and a corrected report is being submitted.

• Brand Name: SAPIEN 3 PULMONIC DELIVERY SYSTEM
• Common Device Name: PULMONARY 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: 18311418
• Report Number: 2015691-2023-18297
• Device Sequence Number: 6718534
• Product Code: NPV
• UDI-Device Identifier: 00690103210873
• UDI-Public: (01)00690103210873(17)240417(11)220418
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P200015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2024
• Device Model Number: 9630PL29A
• Device Lot Number: 64248688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown