MAUDE Adverse Event Report: EDWARDS LIFESCIENCES STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS; HEART-VALVE, MECHANICAL

Model Number 1260A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Aortic Regurgitation (1716)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information were unsuccessful.If additional information is received a supplemental mdr will be submitted.The device history record (dhr) review could not be performed as the serial number is unknown.Without additional information the cause of the event remains indeterminable.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Article "use of mechanical valve prostheses in adults with tetralogy of fallot" international journal of cardiology 291 (2019) 45-49.Https://doi.Org/10.1016/j.Ijcard.2019.02.028.Background: there are limited data about the outcomes mechanical prostheses in adults with tetralogy of fallot (tof).The purpose of the study was to describe the incidence of mechanical valve related adverse events (mvrae), reoperation and all-cause mortality in tof patients with mechanical valve prostheses.Methods: we reviewed the machd (mayo adult congenital heart disease) database and identified all adult tof patients with mechanical valve prostheses, 1990¿2017.Mvrae was defined as valve thrombosis, endocarditis, embolic stroke or major bleeding complications.Results: a total of 44 prostheses were implanted in 29 patients (age 44±13 years; men 18 [62%]), and 10 (36%) patients received multiple mechanical prostheses.The median number of prior sternotomies was 3 (range 2¿7).Target intentional normalized ratio (inr)was 2.0¿3.0 for patients with isolated mechanical aortic prostheses (n= 12, 41%), 2.5¿4.0 for mechanical prostheses in non-aortic positions.There were no surgical deaths, and 10 mvrae (endocarditis [n = 4], major bleeding complications [n = 5] and valve thrombosis [n= 1]) occurred in 7 (24%) patients during a median follow-up of 11 (5 18) years.The 10-year survival and freedom from reoperation were 87% and 95% respectively.Conclusions: surgical mortality and valve thrombosis for mechanical valve prostheses are low presumably due to appropriate patient selection and meticulous anticoagulation.Endocarditis and bleeding complications are major concerns.Further studies are required to determine the appropriate target inr that provides the optimal balance between preventing valve thrombosis and avoiding major bleeding complications mechanical valve prostheses in different positions.This case is for:a 10a starr-edwards mechanical valve was explanted after an implant duration of approximately 29 years due to unknown reasons.It was reported the patient was (b)(6) years old at time explant.Patient had aortic valve explanted at the time of the pulmonary valve replacement.The starr-edwards valve was originally implanted due to bicuspid aortic valve and aortic regurgitation.The explanted device was replaced with a 21mm carbomedics mechanical prosthesis.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9262625
• MDR Text Key: 167133095
• Report Number: 2015691-2019-04047
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P870038/S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1260A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR