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

Model Number 9600TFX23A

Device Problems Calcified (1077); Material Deformation (2976)

Patient Problem Dyspnea (1816)

Event Date 04/11/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by the field clinical specialist (fcs), 4 years, 2 months, and 26 days post-implant of a 23 mm sapien 3 valve in the aortic position, the patients existing sapien 3 was somewhat "crushed" from an unknown force.There is no record of cpr that would have crushed the valve.The patient was experiencing dyspnea and unable to walk any distance.The gradient before the valve in valve was 150mm by pigtail catheter and reduced to 7mm post implant of the valve-in-valve with the 23mm s3ultra resilia.The patient was post-dilated with 23mm true balloon.Imagery was provided by the complaint site and the following observations were made: valve frame was deformed.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from additional response from a medical record review.Investigation is ongoing.

Event Description

As reported by the field clinical specialist (fcs), 4 years, 2 months, and 26 days post-implant of a 23 mm sapien 3 valve in the aortic position, the patients existing sapien 3 was somewhat "crushed" from an unknown force.There is no record of cpr that would have crushed the valve.The patient was experiencing dyspnea and unable to walk any distance.The gradient before the valve in valve was 150mm by pigtail catheter and reduced to 7mm post implant of the valve-in-valve with the 23mm s3ultra resilia.The patient was post-dilated with 23mm true balloon.Imagery was provided by the complaint site and the following observations were made: valve frame was deformed.After reviewing the medical records provided, the patient had the implantation of a 23mm s3ur inside the 23mm s3 valve as valve-in-valve.The bioprosthetic aortic valve frame was partially crushed by an unknown cause, which resulted in severe bioprosthetic aortic valve stenosis, and the patient had to be urgently admitted to the ed with worsening chest pain and shortness of breath.On exam, patient was in respiratory distress and complains of (c/o) active chest pain.The patient was found to be in tachycardia, hypotensive and diaphoretic and required bipap due to hypoxia.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from additional response from an engineering evaluation.The following sections of this report has been updated: update to b4, g3, g6, h2, h6, h10.The product was not returned; therefore, a no product return investigation was completed.As a device was not returned, visual inspection, functional testing, and dimensional testing were unable to be done.Imagery was provided by the complaint site and the following observations were made by ew proctor/imager review: valve frame was deformed and there was significant calcification presented on the leaflets.Review of the work orders above did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.The commander delivery system with s3/s3u ifu was reviewed.Potential adverse events include: 'valve stenosis' and '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)'.Warnings include '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'.No ifu/training deficiencies were identified.The complaints for calcification and valve damage were confirmed based on the provided imagery and medical records.A review of the dhr, lot history and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu/training materials revealed no deficiencies.For the complaint calcification, an existing technical summary written by edwards lifesciences documents the root cause analysis on valve calcification over the time in patient.Per the technical summary, 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.Edwards' thv valves undergo thermafix tissue processing, which is a heat treatment process used to reduce calcification variability and lower calcification levels in comparison to xenologix process.Clinical results of thv implantation show similar mortality and significantly lower svd rate compared with surgical aortic valve replacement after 6 years of functioning.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 calcification from occurring in bioprosthetic valves.Furthermore, evaluation of reported complaints for calcification did not confirm any manufacturing non-conformances and identified that the proper manufacturing mitigations have been implemented.Additionally, per the technical summary, no evidence of a product non-conformance or device malfunction were found in any of the valves returned for these complaints.A s noted, a transthoracic echocardiology report indicated on the aortic valve that there was moderate calcification on the valve leaflets, and per imaging evaluation, there was significant calcification present on the leaflets.In this case, patient had vast comorbidities (esrd, peritoneal dialysis), which are known factors that may increase the risk of valve calcification leading to early valve degeneration.It is well known that patients with chronic renal disease are predisposed to bioprosthetic heart valve calcification.Tissue calcification is a very common failure mode of structural valve deterioration (svd), which can manifest in the form of stenosis.As such, available information suggests that patient factors (pre-existing comorbidities) may have contributed to the reported event.The technical summary is applicable to this complaint because valve calcification was likely due to patient conditions.For the complaint valve damage, 'the bioprosthetic aortic valve frame was partially crushed by an unknown cause', due to limited information provided, a definitive root cause is unable to be determined at this time.No device or labeling problem was identified during the evaluation.Therefore, no further escalation (capa/scar/pra) is required.Control limits are managed and assessed through a document written by edwards lifesciences.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.Since no edwards defects were identified, no corrective or preventative actions are required.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, 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: 19172445
• MDR Text Key: 340916445
• Report Number: 2015691-2024-03101
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194340
• UDI-Public: (01)00690103194340(17)210914
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 04/24/2024; Not provided
• Supplement Dates FDA Received: 05/09/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2019
• 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
• Patient Age: 56 YR
• Patient Sex: Male