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

Model Number	9300TFX
Medical Device Problem Codes	Calcified (1077); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Insufficient Information (4580)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by implant patient registry, approximately 7 years and 8 months post transfemoral tavr procedure with a 26mm sapien xt valve in the pulmonic position the valve was explanted due to unknown reasons.An edwards surgical valve was implanted.
Additional Manufacturer Narrative
Per the instructions for use (ifu), non-emergent reoperation, emergency cardiac surgery, reoperation, device migration or malposition requiring intervention and device explant are listed as potential risks associated with the device and transcatheter valve replacement procedure.The ifu cautions that long-term durability has not been established for the valve.Regular medical follow-up is advised to evaluate valve performance.Accelerated deterioration of the valve due to calcific degeneration may occur in children, adolescents, or young adults and in patients with an altered calcium metabolism.Valve recipients should be maintained on anticoagulant/antiplatelet therapy, except when contraindicated, as determined by their physician.This device has not been tested for use without anticoagulation.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 this adverse event is not required at this time.Valve reintervention may be due to valve dysfunction (e.G., severe, or clinically significant paravalvular leak, central leak, significant malposition, early/late endocarditis, thrombosis, structural valve deterioration or degeneration) and/or other reasons unrelated to the edwards devices (e.G., treatment of other patient comorbidities).During the manufacturing process, all sapien valves (all models) are 100% visually inspected for defects and 100% tested under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.In this case, despite multiple investigational attempts, it was not possible to obtain additional details regarding this event.Due to limited information, a definitive root cause was unable to be determined at this time.At the time of this report, the information available does not reasonably suggest there was a malfunction of the edwards device or that the use or miss-use of the device caused or contributed to the event.There is no allegation of deficiencies related to the identity, quality, durability, reliability, safety, labeling effectiveness, or performance of this edward device.Should additional information become available, the information will be reviewed, and the file updated accordingly.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.H3 other text : the valve was not returned for evaluation.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to additional information and correction from medical records.The following sections of this report have been updated: b.4, b.5, b.7, g.3, g.6, h.2 and h.6.The following sections of this report have been corrected: b1 (corrected to both adverse event and product problem) h.6 clinical code (from 4580 to 1816), device code (from 3190 to 1077), investigation findings (from 3221 to 213) and h.10.Per the instructions for use (ifu), structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis), is a potential adverse event associated with bioprosthetic heart valves.Per a technical summary written by edwards lifesciences, calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards' tissue valves due to subsequent anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprosthesis from calcifying.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate a definitive root cause could not be determined due to limited information received.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 this adverse event 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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.
Event or Problem Description
Per medical record review a tte performed approximately 7 years and 3 months post tpvr showed the valve had severe pv stenosis, moderate to severe regurgitation and pv mean gradient 52mmhg.The valve was explanted and found to be heavily calcified.

• Brand Name: EDWARDS 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: 18991080
• Report Number: 2015691-2024-02366
• Device Sequence Number: 18043784
• Product Code: NPV
• UDI-Device Identifier: 00690103192087
• UDI-Public: (01)00690103192087(17)170226
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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): 04/19/2024

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: 02/26/2017
• Device Model Number: 9300TFX
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 30 YR
• Patient Sex: Female