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

Model Number 9600TFX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endocarditis (1834)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

This is one of twenty manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2024-02917, 2015691-2024-02918, 2015691-2024-02920, 2015691-2024-02921, 2015691-2024-02930, 2015691-2024-02931, 2015691-2024-02955, 2015691-2024-02960, 2015691-2024-02968, 2015691-2024-02970, 2015691-2024-02971, 2015691-2024-02974, 2015691-2024-02978, 2015691-2024-02980, 2015691-2024-02982, 2015691-2024-02983, 2015691-2024-02985.Citation: nidal jammoul, md, valentin dupasquier, md, mariama akodad, md, phd, pierre-alain meunier, md, lionel moulis, md, sonia soltani, jean-christophe macia, md, pierre robert, md, laurent schmutz, md, matthieu steinecker, md, christophe piot, md, frederic targosz, md, henri benkemoun, md , benoit lattuca, md, phd, francois roubille, md, phd, guillaume cayla, md, phd, and florence leclercq, md, phd (b)(6), france; (b)(6), france; (b)(6), france.''long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the directavi trial'' per the instructions for use (ifu), infections such as septicemia and endocarditis are known potential adverse events associated with the thv procedure.Endocarditis is an infection of a native or prosthetic valve, is treated with antibiotics, and may require valve replacement if antibiotic therapy is not effective.Causes of prosthetic valve endocarditis are well documented in the literature and are typically classified as early (<60 days) or late (>60 days).The two categories show definite differences in clinical features, microbial patterns, and mortality.According to the literature review, and as documented in a technical summary written by ew, early prosthetic valve endocarditis is usually caused by perioperative bacterial contamination of the valve.In early cases of prosthetic endocarditis, subsequent infections may be related to contamination at the time of surgery (poor sterile technique).Additional causes of early pve can occur from other sources of infection and not from the valve (e.G., dental treatment or surgical procedures involving the upper respiratory tract, utis, pneumonia).Additionally, a non-conformance in the sterility or packaging processes of the valve may also manifest in the early post-operative period causing early pve.However, there are several types of bacteria that would not survive the edwards sterilization process.Late prosthetic valve endocarditis is usually caused by an infection that occurs elsewhere in the body and then seeds the valve.The most frequent causes are dental procedures, urological infections, invasive interventions, and indwelling catheters.According to the literature review, and as documented in a technical summary written by ew, the major microbial difference between late and early pve is the higher incidence of streptococcal organisms.Late pve resembles native valve endocarditis in terms of etiological microbes, and sources of contamination are presumably similar.Late endocarditis occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the body and is not in any way related to the sterilization or packaging process of the device.Dental, genitourinary, and gastrointestinal manipulation are known causes of transient bacteremia.By 60 days, implanted valves will be endothelialized, so that a larger inoculum may be required to cause late compared with early pve.Edwards lifesciences produces and provides sterile tissue bioprosthesis to its customers by following carefully designed robust sterilization processes.These manufacturing processes have been validated and demonstrated to consistently provide a significant safety factor from which microorganisms could not survive.Microbiology and process monitoring is routinely reviewed within quality systems to maintain sterility control.Validated testing has demonstrated that microorganisms could not survive edwards multi-stage processing with enhanced sterilant or heated glutaraldehyde terminal sterilant solution.These multiple, redundant manufacturing controls ensure the sterility of edwards valves as provided to customers.Therefore, the probability of endocarditis related to edwards bioprosthesis is remote.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.There is no information regarding the onset of the endocarditis.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 Description

A review of medical article ''long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the directavi trial'' was performed.The aim of this study was to evaluate the impact of the implant strategy on long-term thv hemodynamic performances and clinical outcomes in patients included in the directavi trial in france.One patient with an unknown sapien 3 valve implanted in aortic position presented endocarditis which led to moderate hvd unknown days after the procedure.

• 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: 19140173
• MDR Text Key: 340564951
• Report Number: 2015691-2024-02987
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other