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

Model Number 9750TFX23

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

Patient Problems Rupture (2208); Pericardial Effusion (3271)

Event Date 02/01/2023

Event Type  Injury  

Event Description

As reported by our affiliates in germany, during the transfemoral transcatheter aortic valve replacement (tavr) procedure of a 23mm sapien 3 ultra valve, the patient presented with a pericardial effusion.The pericardial effusion was aspirated by puncturing the pericardial sac.A drainage was then placed.The patient also needed blood transfusion.The event resolved.

Manufacturer Narrative

Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures, annular tear, or rupture are known potential risks or adverse events associated with the overall transcatheter heart valve (thv) procedure and may require intervention.According to the thv training manuals, risk factors for aortic dissection, hematoma, or annular rupture during the thv procedure include significant thv oversizing, severely obliterated sinuses of valsalva, porcelain aorta, and/or presence of bulky calcification and narrow calcified stj.In addition, advanced age, female gender, small body weight, and steroid dependency can also be contributing factors.The sapien valve relies on native valve calcium to securely anchor to the annulus.Despite this beneficial aspect of calcium, bulky calcium can increase the risk of calcific nodule displacement into the vasculature, which can lead to cardiovascular injury.At times, the extent and distribution of calcium can impair ease of delivery of the valve, correct positioning of the valve, deployment of the valve, and procedural success.Pericardial effusion is an abnormal accumulation of fluid in the pericardial cavity.Because of the limited amount of space in the pericardial cavity, fluid accumulation will lead to an increased intra pericardial pressure which can negatively affect heart function.When there is a pericardial effusion with enough pressure to adversely affect heart function, this is called cardiac tamponade.It can be caused by a variety of local and systemic disorders, or it may be idiopathic.Pericardial effusions can be acute or chronic, and the time course of development has a significant impact on the patient's symptoms.In thv patients, it may be caused by guidewire perforations or annular ruptures.In transapical patients, postoperative pericardial effusions are common, most will resolve spontaneously, and some may require intervention.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.The cause of the pericardial effusion is unknown; however, patient factors not provided and/or procedural factors may have caused or contributed to this event.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 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.No corrective or preventative actions are required.Device remains implanted.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and includes additional information received.The following sections of this report have been corrected/updated: b7 (other relevant history, including preexisting medical conditions), h6 (health effect - clinical code) and h10 (provide narrative/data).Per the initial report, during the transfemoral transcatheter aortic valve replacement (tavr) procedure of a 23mm sapien 3 ultra valve, the patient presented with a pericardial effusion.The pericardial effusion was aspirated by puncturing the pericardial sac.A drainage was then placed.The patient also needed blood transfusion.The event resolved.Additional information was received revealing that the cause of the pericardial effusion was an annular rupture.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures, and hematoma are known potential adverse events associated with the overall transcatheter heart valve (thv) procedure and may require intervention.According to the thv training manuals, risk factors for aortic dissection, hematoma, or annular rupture during the thv procedure include significant thv over sizing, severely obliterated sinuses of valsalva, porcelain aorta and/or presence of bulky calcification, and narrow calcified stj.In addition, advanced age, female gender, small body weight, and steroid dependency can also be contributing factors.The sapien valve relies on native valve calcium to securely anchor to the annulus.Despite this beneficial aspect of calcium, bulky calcium can increase the risk of calcific nodule displacement into the vasculature, which can lead to vascular injury.At times, the extent and distribution of calcium can impair ease of delivery of the valve, correct positioning of the valve, deployment of the valve, and procedural success.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest patient factors (severe calcification that was reaching into the left ventricular outflow tract) may have caused or contributed to this event.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 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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: EDWARDS SAPIEN 3 ULTRA 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: 16453788
• MDR Text Key: 310358975
• Report Number: 2015691-2023-11150
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

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: 9750TFX23
• Device Catalogue Number: 9750TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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 Age: 70 YR
• Patient Sex: Male