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

Model Number SAPIEN VALVE UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problem Death (1802)

Event Date 02/10/2021

Event Type  Death  

Manufacturer Narrative

Please reference article al hijji mohammed a et al temporal outcomes of transcatheter mitral valve replacement in native mitral valve disease with annular calcification.Catheterization and cardiovascular interventions 2021.The dates of the events are unknown; however, according to the article the study period was from january 14 2014 to march 15 2019.For this reason the first day of the reported study period january 14 2014 was used as the occurrence date.In this case the exact valve model number is not available.Therefore this report will reflect an unknown edwards sapien transcatheter heart valve.The possible pma numbers associated with an edwards sapien transcatheter heart valves for this article are p130009 edwards sapien xt transcatheter heart valve p140031 edwards sapien 3 transcatheter heart valve and edwards sapien 3 ultra heart valve.This is five of eight manufacturer reports being submitted for this case.The edwards sapien 3 transcatheter heart valve model 9600tfx and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team including a cardiac surgeon to be at low risk for open surgical therapy ie predicted risk of surgical mortality greater or equal to 1 percent at 30 days based on the society of thoracic surgeons risk score and other clinical comorbidities unmeasured by the sts risk calculator.The edwards sapien 3 transcatheter heart valve model 9600tfx and accessories are indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon to be at low risk for open surgical therapy (ie predicted risk of surgical mortality equal to 8 percent at 30 days, based on the sts risk score and other clinical comorbidities unmeasured by the sts risk calculator).Per report, the device was used in an off label implantation in the mitral position.As there are no specific ifu or training materials related to mitral procedures the available training materials were reviewed only for information potentially relevant to the device use.Paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (tvr) procedure.The patient screening manual and the procedure didactic identify several procedural and anatomical factors which could contribute to pvl, including device malposition, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, an elliptical annulus shape and valve under-sizing.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest the cause of the pvl is unknown.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

As reported through written article 'temporal outcomes of transcatheter mitral valve replacement.In native mitral valve disease with annular calcification' the following event was reported in table 2 for procedural outcomes: 1 patient died a few days later after unsuccessful attempt for transcatheter paravalvular mitral regurgitation closure due to multiorgan failure.

Manufacturer Narrative

This is one of eight manufacturer reports being submitted for this case.Please reference related manufacturer reports: 2015691-2021-01693, 2015691-2021-01694, 2015691-2021-01696, 2015691-2021-01697, 2015691-2021-01700, 2015691-2021-01701, 2015691-2021-01703.

• Brand Name: SAPIEN VALVE UNKNOWN
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11423417
• MDR Text Key: 234994221
• Report Number: 2015691-2021-01699
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention