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

Model Number SAPIEN 3 UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problem Aortic Regurgitation (1716)

Event Date 01/01/2015

Event Type  Injury  

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, 1 patient had greater than mild aortic regurgitation.

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.Regurgitation can either be paravalvular leak (pvl), central leak though the valve and/or a combination of both.Regurgitation after transcatheter heart valve replacement is not uncommon and may vary in severity.Many cases are mild and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.If the regurgitation does not require an intervention to treat, the event is not mdr reportable.Per the article, 1 patient had greater than mild aortic regurgitation.There was no indication that the patient required hospitalization and/or an intervention to treat the regurgitation.Therefore, the event does not meet the criteria of a reportable event.A corrected report is being submitted.

• 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: 11098733
• MDR Text Key: 224799227
• Report Number: 2015691-2020-15338
• 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

• Date FDA Received: 12/30/2020
• 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
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other