MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA SJM REGENT HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 19AGN-751

Device Problems Gradient Increase (1270); Leak/Splash (1354)

Patient Problem Aortic Regurgitation (1716)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, an aortic valve replacement was performed and this 19 mm regent mechanical heart valve was implanted.Since the patient was discharged from the hospital, the patient's lactate dehydrogenase (ldh) had gradually increased.At the end of (b)(6) 2016, an echo revealed a mean pressure gradient (mpg) of 43 mmhg and peak pressure gradient (ppg) of 74 mmhg.The level of ldh was noted to be 800 iu/l.On (b)(6) 2016, mild to moderate aortic regurgitation was diagnosed through an echo.At that time, mpg was 68 mmhg and ppg was 116 mmhg.On (b)(6) 2016, this valve was explanted due to impeded leaflet mobility.Upon explant of this valve, neither thrombus nor pannus was observed but one of the leaflets was impeded.No signs or symptoms of infective endocarditis were confirmed.A 16 mm non-sjm mechanical heart valve (ats open pivot heart valve/medtronic) was implanted.

Manufacturer Narrative

The results of this investigation concluded there was limited mobility of both leaflets.It is unknown how or when this anomaly occurred.However, a dried red substance appearing to be blood/body fluids was observed in all four recessed pivot areas during the initial gross analysis.This may have contributed to the resistance observed when manually manipulating the leaflets.Several chips were observed on the top and bottom rim of the orifice.It is unknown how or when this damage occurred.However, the damage to the orifice may have been caused by some external force applied to the orifice, which overstressed the carbon material during explant.No acute inflammation was present in the valve.A review of the device history record showed the device met specifications prior to leaving sjm manufacturing facilities.There was no evidence found to suggest the cause of the chipped orifice or restricted leaflets were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

• Brand Name: SJM REGENT HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6245342
• MDR Text Key: 64610675
• Report Number: 3008452825-2017-00006
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2019
• Device Model Number: 19AGN-751
• Device Catalogue Number: 19AGN-751
• Device Lot Number: 4472691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 11 YR