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

Model Number 9600TFX29A

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

Patient Problems Vascular Dissection (3160); Foreign Body Embolism (4439)

Event Date 01/17/2023

Event Type  Injury  

Event Description

As reported, a transcarotid case was scheduled with the plan to go on the right side using a 29mm certitude system as the vessel diameters met criteria.Prior to the start of case, a surgeon recommended the primary operator to access the left side rather than the right.After carotid cutdown of the left side, there was reported "resistance" with the non-edwards wire and switched to another non-edwards guide wire.An edwards sheath was advanced, and the first valve deployed at 80/20 with a gradient of 4mmhg and no leak.A white object was noted during evaluation of the echo from transesophageal echocardiogram (tee), it appeared to "flail" from the bottom of the valve stent frame into the left ventricular outflow tract obstruction (lvot).The decision was made to implant a second valve to secure and lock the object into place between the two sapien valves and native valve, once the second valve was implanted, the object was no longer visible on tee.There was no leak, and the gradient remained at 4mmhg.Upon removal of the certitude sheath at the end of the case, a significant carotid dissection that was believed to have occurred during wire advancement through the carotid artery.The carotid artery was ligated to stop bleeding.The patient was successfully transferred to the icu, extubated, and was following commands on post operative day 1.

Manufacturer Narrative

Device remains implanted.Per the instructions for use (ifu), potential adverse events associated with the overall procedure include thrombus formation, plaque dislodgment, and embolization that may result in myocardial infarction, stroke, distal peripheral occlusion, and/or death.It is the natural tendency of the body to form a clot on foreign objects in the vascular space.These patients are anticoagulated for the procedure and interventional best practices mandate meticulous wiping and flushing of the devices to prevent and/or remove the clot.The thv training manuals and ifu instruct the operator to administer heparin and maintain the act at = 250 sec.Per the instructions for use (ifu), emboli is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential risks or adverse events associated with the overall thv procedure and may require intervention.According to the literature review, and as documented in a technical summary written by ew, vascular complications are a well-recognized complication of the transfemoral thv procedure in this elderly population with multiple co-morbidities.Edwards has reviewed many reports, including screening data records and source documentation of vascular complications, and has found that the root cause is typically related to a combination of vessel size, tortuosity, and calcifications.Although the incidence is decreasing with smaller sheath/delivery system sizes and physician experience, there will continue to be cases in which vascular complications will occur.The thv physician training manuals instruct on procedural considerations for sheath insertion with regards to proper screening critical to reducing vascular complications.The training manual instructs the operator on proper sheath insertion and withdrawal techniques, including pre-dilating the vessel with the edwards dilators, as needed.It also notes that calcification may reduce lumen diameter and limit or prevent the transfemoral passage of the devices.The ifu contraindicates patients with ilio-femoral vessel characteristics that would preclude safe placement of sheaths such as severe obstructive calcification or severe tortuosity.Pre procedure screening and assessment of the femoral/iliac artery internal diameters will enable the clinician to determine if the sapien valve can be delivered transfemorally.Assessment of location and amount of circumferential calcium will aid in determining areas of reduced vessel diameters.The operators are trained to measure minimum vessel diameter taking calcium into account.The physician training manual also lists the minimum recommended vessel size for each size device.Despite the best screening tools, a small percentage of patients will have femoral/iliac vessels that are not amenable to the trans-femoral approach or where increased resistance is encountered during insertion of devices.In many cases, the vessel minimum luminal diameter (mld) may be borderline or below the indicated size.In addition, significant calcification and/or tortuosity, not always appreciable on imaging, could be contributing factors to the event.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results indicate that the patient was known to have challenging vessels and there was some tortuosity and this caused or contributed to this event.The reported event (foreign body embolism) was likely tissue calcium and the reported event (vascular dissection) is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.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.Device not returned.

• 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: 16342286
• MDR Text Key: 309259674
• Report Number: 2015691-2023-10707
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)250810
• 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
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• Is the Device Single Use?: No
• 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: Male