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

Model Number SAPIEN 3 UNKNOWN

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

Patient Problem Death (1802)

Event Date 01/01/2015

Event Type  Death  

Manufacturer Narrative

The dates of the events are unknown.The first day of the first month of the range used as the occurrence date, (b)(6) 2015.Article reference: eftychiou, christos, nicolaos eteocleous, ioannis zittis, krikor simamonian, antonis ioannou, pantelitsa loukaidou, aliki ntaka et al."outcomes of transfemoral transcatheter aortic valve implantation (tavi) and predictors of thirty-day major adverse cardiovascular events (mace) and one-year mortality." hellenic journal of cardiology (2020).The investigation is ongoing.

Event Description

As reported by our affiliates in (b)(6), per the article ¿outcomes of transfemoral transcatheter aortic valve implantation (tavi) and predictors of thirty-day major adverse cardiovascular events (mace) and one-year mortality¿, data of 178 patients who received a sapien 3 valve at a single center from january 2015 to march 2020 were reviewed.During the study period, there were 5 cardiovascular deaths.

Manufacturer Narrative

This is one of five manufacturer reports being submitted for this article.Please reference related manufacturer report numbers: 2015691-2020-15334, 2015691-2020-15335, 2015691-2020-15336, 2015691-2020-15337, 2015691-2020-15338.Patients undergoing thv procedures often have complex medical histories, multiple co-morbidities in addition to limited cardiac reserve that can impair recovery from the procedure.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The article did not provide the exact cause of death or event details for the patients who expired post implant.There was insufficient information provided by the authors to determine the root cause of the events.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.

• Brand Name: SAPIEN 3 UNKNOWN
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11098696
• MDR Text Key: 224510813
• Report Number: 2015691-2020-15334
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

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 3 UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death