MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number SAPIEN VALVE UNKNOWN

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

Patient Problem Hemolysis (1886)

Event Date 12/24/2020

Event Type  Injury  

Manufacturer Narrative

It was unknown which valve the patient received sapien, sapien xt or sapien 3 valves.The pma numbers are p110021, p130009 and p140031, respectively.The date of the event is unknown.Therefore, the date the article was received, (b)(6) 2020, was used as the occurrence date.Article reference: eng, marvin h., faraj kargoli, dee dee wang, tiberio m.Frisoli, james c.Lee, pedro s.Villablanca, hassan nemeh et al.Short and mid term outcomes in percutaneous mitral valve replacement using balloon expandable valves.Catheterization and cardiovascular interventions (2021).Hemolysis is the destruction of red blood cells.There are multiple extrinsic and intrinsic factors including use of extracorporeal circulation, transfusion, infection, tumors, autoimmune disorders, medication side effects, a metabolic abnormality, and red blood cell membrane instability.Normal red blood cells (erythrocytes) have a lifespan of about 120 days.After they die they break down and are removed from the circulation by the spleen.In some medical conditions, or as a result of taking certain medications, this breakdown of red blood cells is increased.Red cells may break down due to mechanical damage, such as from artificial heart valves or heart lung bypass; or they may be destroyed due to defects in the cells themselves.Medications that have been associated with hemolysis include acetaminophen, penicillin, and other pain medications.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The cause for the hemolysis could not be determined with the information provided by the authors.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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

Event Description

Per the article, short and midterm outcomes in percutaneous mitral valve replacement using balloon expandable valves, from august 2013 to december 2019, a total of 88 cases of transcatheter mitral valve replacement (tmvr) were performed at single center.A total of 38, 31, and 19 patients were treated with a valve in valve, valve in ring, or valve in native mitral annulus, respectively.During the study period, during the study period, 1 patient experienced major blood loss due to hemolysis and required transfusion of 3 units of packed cells.

• Brand Name: SAPIEN VALVE UNKNOWN
• Type of Device: 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
• MDR Report Key: 12418531
• MDR Text Key: 270666199
• Report Number: 2015691-2021-04987
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2021

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: SAPIEN VALVE UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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