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

Model Number 9600TFX23A

Device Problems Gradient Increase (1270); Structural Problem (2506)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Date 10/14/2022

Event Type  Injury  

Event Description

As reported by the field clinical specialist, approximately 7 years post transfemoral tavr procedure with a 23mm sapien 3 valve in the aortic position, a basilica was performed on the failed valve leaflet beneath left coronary artery.The patient underwent a valve-in-vale procedure with a 20mm s3u valve deployed with 2ml added to contrast volume.With approximately 2ml of contrast volume left in the inflation syringe, a balloon rupture was noted.The commander delivery system was removed from the patient without any difficulty.A 21mm true balloon was inserted to post dilate.An angiogram, hemodynamics and echo were preformed after post dilation which were all satisfactory.The patient suffered no apparent injury related to balloon rupture.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted when additional information is provided.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections g6, h2, h6: clinical code, device code, type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned, and no imagery was provided for evaluation.As no device was returned, engineering was unable to perform visual inspection, functional testing, or dimensional testing.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.The complaint was unable to be confirmed as no imagery/medical record was provided for evaluation.The reported event does not allege a device malfunction that could be related to an edwards manufacturing deficiency.An existing technical summary written by edwards lifesciences documents the root cause analysis on valve calcification over the time in patient.Per 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 transcatheter heart valve(s) (thv) 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 small vessel disease (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 similar reported complaints did not confirm any manufacturing non-conformances and identified that the proper manufacturing mitigations have been implemented.Additionally, per technical summary, no evidence of a product non-conformance or device malfunction were found in any of the valves returned for these complaints.As reported, "approximately 7 years post transfemoral transcatheter aortic valve replacement (tavr) procedure with a 23mm sapien 3 valve in the aortic position, the patient was experiencing shortness of breath and the s3 valve was failing due to leaflet calcification and thrombosis, under expanded thv".Additionally, per the event description, "the s3 valve was noted to have mild regurgitation, mean gradient 47 mmhg, velocity 4.6 (m/s), ava 0.69 cm2" and "the s3 leaflet motion was restricted, with calcification in the non-coronary cusp (ncc), and hypoattenuated leaflet thickening (halt) was seen on computed tomography angiography (cta) related to ncc leaflet." while a definitive root cause was unable to determine due to limited information provided, the technical summary indicates that valve calcification is likely related to patient factors.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.Since no edwards defect was identified, no corrective or preventative action is required.This supplemental is one of two reports being submitted for this case.Please reference manufacturer report number 2015691-2022-08878.

• 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: 15686751
• MDR Text Key: 302567727
• Report Number: 2015691-2022-08877
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194340
• UDI-Public: (01)00690103194340(17)160829
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2016
• Device Model Number: 9600TFX23A
• Device Catalogue Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2015
• 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 Sex: Female