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

Model Number	9300TFX29A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), approximately 8 years, 3 months 20 days post transfemoral tpvr procedure.With a 29mm sapien xt valve.The patient present shortness of breath, dyspnea on exertion, and chest pain, due to regurgitation.The patient underwent a valve in valve procedure with a 29mm sapien 3 ultra resilia valve.There was no additional information provided.
Additional Manufacturer Narrative
Correction to h6 based on additional information.The complaint for central leak was unable to be confirmed due to unavailability of medical records/relevant imagery.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.It should be noted that the thv was implanted in native pulmonic valve, which is not an indicated for use at the time of original implantation.Therefore, this was off label operation.During the manufacturing process, all sapien xt valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the reported event.As reported, 'approximately 8 years, 3 months, 20 days post transfemoral tpvr procedure with a 29mm sapien xt valve, the patient present shortness of breath, dyspnea on exertion, and chest pain due to central regurgitation.The patient underwent a valve in valve procedure with a 29mm sapien 3 ultra resilia valve'.Per the instructions for use (ifu), valve regurgitation is a potential adverse event associated with bioprosthetic heart valves and the tavr procedure.Regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration, including calcification, non-calcific degeneration, leaflet thickening or fibrosis, or a combination of these.Regurgitation may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with functionality of the device by restricting the leaflet motion leading to abnormal coaptation.Due to insufficient information a definitive root cause was unable to be determined 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.No corrective or preventative actions are required.
Additional Manufacturer Narrative
Correction to h6 based on additional information.The complaint for central leak was unable to be confirmed due to unavailability of medical records/relevant imagery.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.It should be noted that the thv was implanted in native pulmonic valve, which is not an indicated for use at the time of original implantation.Therefore, this was off label operation.During the manufacturing process, all sapien xt valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the reported event.As reported, 'approximately 8 years, 3 months, 20 days post transfemoral tpvr procedure with a 29mm sapien xt valve, the patient present shortness of breath, dyspnea on exertion, and chest pain due to central regurgitation.The patient underwent a valve in valve procedure with a 29mm sapien 3 ultra resilia valve'.Per the instructions for use (ifu), valve regurgitation is a potential adverse event associated with bioprosthetic heart valves and the tavr procedure.Regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration, including calcification, non-calcific degeneration, leaflet thickening or fibrosis, or a combination of these.Regurgitation may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with functionality of the device by restricting the leaflet motion leading to abnormal coaptation.Due to insufficient information a definitive root cause was unable to be determined 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.No corrective or preventative actions are required.
Additional Manufacturer Narrative
Correction to b5 due to additional information received.
Event or Problem Description
It was initially reported by the field clinical specialist (fcs), approximately 8 years, 3 months, 20 days post transfemoral tpvr procedure with a 29mm sapien xt valve, the patient present shortness of breath, dyspnea on exertion, and chest pain due to regurgitation.The patient underwent a valve in valve procedure with a 29mm sapien 3 ultra resilia valve.Per additional information received, the reported regurgitation was confirmed to be central leak.

• Brand Name: SAPIEN XT TRANSCATHETER HEART VALVE
• 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: 17393879
• Report Number: 2015691-2023-14836
• Device Sequence Number: 7571691
• Product Code: NPV
• UDI-Device Identifier: 00690103193176
• UDI-Public: (01)00690103193176(17)161016
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P130009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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,Followup,Followup
• Report Date (Section B): 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2016
• Device Model Number: 9300TFX29A
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/18/2023; 09/07/2023; 09/07/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/22/2023; 09/08/2023; 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male