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 Stroke/CVA (1770)

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, 2015691-2024-02987.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 montpellier, france; chu montpellier, france; nimes, 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), permanent or transient neurological events such as transient ischemic attack (tia) and stroke are known potential adverse events associated with the thv procedure and the use of the edwards thv devices.According to the literature review, and as documented in a clinical technical summary written by ew, stroke is recognized in the literature as a well-known complication in a small number of patients undergoing thv.Risk factors correlating with several patient co-morbidities have been identified.Although in many cases the root cause of the event is unable to be determined, strokes during thv are undoubtedly multifactorial, the dominant etiology likely being intra-procedure embolic events.A transcranial doppler study during thv demonstrated that most procedural embolic events occurred during balloon valvuloplasty, manipulation of catheters across the aortic valve, and valve implantation.An analysis in patients undergoing valve surgery revealed four baseline characteristics and two procedural events that were associated with early post-procedure stroke: female sex, ef < 30%, diabetes, age older than 70 years, bypass procedure time> 120 min, and calcification of the ascending aorta.Predictors of late stroke have included female sex, age older than 75 years, atrial fibrillation, and a history of or current smoking.There were no significant differences in the frequency of late strokes between thv and avr patients.After thv, there appears to be a more considerable proportion of early strokes occurring < 24 h post-procedure, but thv patients with multiple co-morbidities are probably at higher risk of both early and late strokes.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 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.Five patients with an unknown sapien 3 valve implanted in aortic position presented stroke 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: 19140283
• MDR Text Key: 340561697
• Report Number: 2015691-2024-02989
• 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

• 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
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/18/2024
• 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