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 Myocardial Infarction (1969)

Event Date 01/01/2017

Event Type  Injury  

Event Description

A review of medical article ''three-year outcomes of balloon-expandable transcatheter aortic valve implantation according to annular size'' was performed.The aim of this study was to evaluate the association between the aortic annulus size and tavi clinical and hemodynamic outcomes at three years of follow-up.During a three-year follow-up period post tavi with sapien 3 valves of unknown sizes, myocardial infarction (mi) occurred in 16 study patients.Out of these 16 study patients, 11 patients had intermediate annuli (400 to 574 mm2), 3 patients had small annuli (400 mm2) and 2 patients had large annuli (575mm2).Four patients required intervention during the follow up period.It is unknown whether the intervention was related to the strokes, mis or conduction defects.

Manufacturer Narrative

This is one of four manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2024-03084.Citation: abdelrahman i.Abushouk, md, nikolaos spilias, md, toshiaki isogai, md, tikal kansara, md, ankit agrawal, md, essa hariri, md, omar abdelfattah, md, amar krishnaswamy, md, grant w.Reed, md, rishi puri, md, james yun, md, and samir kapadia, md ''three-year outcomes of balloon-expandable transcatheter aortic valve implantation according to annular size''.Per the instructions for use (ifu), thrombus formation, plaque dislodgement, and embolization that may result in myocardial infarction (mi) are potential adverse events associated with the overall thv procedure.The ifu cautions that the safety and effectiveness have not been established for patients with bulky calcified aortic valve leaflets near the coronary ostia.In addition, caution should be exercised when implanting a bioprosthesis in patients with clinically significant coronary artery disease.Mi related to the thv procedure, and the valve implant will manifest intra-procedurally or in the immediate post-operative period and is typically due to a combination of patient and/or procedural factors.As defined in the valve academic research consortium (varc) publication on thv complications, the peri-procedural interval is inclusive of all events that begin within 72 hours of the index procedure.Mi's that occur after the peri-procedural period (72hrs) are typically related to the patient's underlying coronary disease.Multiple patient factors could put the patient at risk for mi during the thv procedure, including significant underlying coronary artery disease, and bulky calcification of the native leaflets and root.Displacement of calcium deposits with embolization of debris into one of the arteries, or aortic dissection with continuity of the rupture into the intima of one of the coronary ostia, can result in this complication.The edwards thv manuals advise the operator on pre-procedure assessment of the aortic valve, root, and coronary anatomy.Physicians are extensively trained by edwards before they are qualified to use the transcatheter heart valve (thv).Training includes patient screening, device preparation, approach, deployment, imaging, procedure specific training manuals, and proctored procedures.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.

• 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: 19166059
• MDR Text Key: 340851136
• Report Number: 2015691-2024-03085
• Device Sequence Number: 1
• Product Code: NPT
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

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: 03/29/2024
• Initial Date FDA Received: 04/23/2024
• 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