MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS CERTITUDE DELIVERY; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number	9600SDS29A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	04/29/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Per the instructions for use (ifu), cardiovascular injuries such as access site complications, perforation of the ventricle or myocardium, bleeding, and injury at the site of ventricular access may require repair and are known potential adverse events associated with the transapical thv procedure.Per the literature review, risk factors for apical laceration and bleeding include friable tissue, fatty apex, chronic steroid use, dilated lv with thinned walls, and hypertension during removal of the sheath.While patient characteristics are important, achieving good hemostatic control of the lv apex is one of the most critical steps in ensuring the success of the transapical procedure, particularly in the elderly with friable tissue.Additional literature review confirms there is a higher incidence of apical bleeding in female patients and patients over 80 years old.This information correlates with the review of complaint history, revealing that the majority of apical bleeding complications appear to be related to surgical technique and/or diseased ventricles during the insertion or removal of the sheath.The thv training manuals note that removal of the sheath and attempted closure of the apical incision may be associated with blood loss.Rapid burst pacing can be used to lower the systemic blood pressure during sheath removal and apical closure.The thv training manuals also recommend the physician consider performing the procedure under full cpb support for certain patients, including those with cardiogenic shock (cardiac index < 2 l/min per square meter) despite volume challenge and inotropic support, profound lv, rv, or biventricular dysfunction, and notably friable apex.Per the instructions for use (ifu), cardiovascular injury is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest that procedural (manipulation of device) and patient factors (small ventricle) caused or contributed to this event.The exact cause of death is unknown.However, the cause maybe due to procedural and patient factors.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 will not be returned.
Event or Problem Description
As reported by the edwards field clinical specialist, post valve deployment of a sapien 3 valve in the native mitral position via transatrial, a tear in the ventricle wall was noted.A.035 wire was inserted through the delivery system to protect the ventricle during deployment.It was thought a perforation from the nose cone of the certitude delivery system occurred.The tear was successfully repaired and there was no bleeding at the site.The procedure was completed.The patient was having some pressure issues as they came off pump.They were able to stabilize her and was transferred for post management care.Approximately 3 days post procedure, the patient expired.The cause of death is unknown.Of note, the patient was administered high does of presser support post-operative.Per report, the patient had a small ventricle.
Additional Manufacturer Narrative
A supplemental mdr is being submitted based upon further clinical review of the closure summary.The section h10 (narrative) of this report has been updated.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential adverse events associated with the overall thv procedure and may require intervention.There are several potential etiologies for ventricular perforation during a thv procedure, including perforation by the guidewire, the delivery system, or the transvenous pacer (tvp) lead.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).Training includes proper guidewire positioning, fixation of the tvp to prevent ventricle perforation, and careful manipulation of devices.Per the procedure didactic, patients with small ventricles are at particularly high risk for ventricular perforation.Per the instructions for use (ifu), (add adverse event name) 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 injury is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest that procedural (manipulation of device) and patient factors (small ventricle) caused or contributed to this event.The exact cause of death is unknown.However, the cause maybe due to procedural and patient factors.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.

• Brand Name: EDWARDS CERTITUDE DELIVERY
• Common Device Name: PROSTHESIS, MITRAL VALVE, 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: 14515981
• Report Number: 2015691-2022-05903
• Device Sequence Number: 5628902
• Product Code: NPU
• UDI-Device Identifier: 00690103194166
• UDI-Public: (01)00690103194166(17)230429(10)63754455
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2023
• Device Model Number: 9600SDS29A
• Device Catalogue Number: 9600SDS29A
• Device Lot Number: 63754455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Female