MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-21A

Device Problem Torn Material (3024)

Patient Problems Aortic Insufficiency (1715); Cusp Tear (2656)

Event Date 11/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 01 april 2014, an aortic valve replacement (avr) was performed and this 21 mm sjm trifecta valve was implanted.Concomitantly, a mitral valve repair was performed and a 24 mm sjm rigid saddle ring was implanted in the mitral annulus.On (b)(6) 2016, the patient was referred by her primary care physician for urgent care.On (b)(6) 2016, the valve was explanted due to early structural valve deterioration (svd), as a leaflet tear was observed.A 21 mm tissue valve from another manufacturer was implanted.Per report, there were no issues noted with the ring; therefore, it remains implanted.The patient is reported to be recovering.

Manufacturer Narrative

The results of this investigation concluded there were tears in leaflets 1 and 3.There was circumferential fibrous pannus ingrowth on the inflow surface with narrowing of the inflow diameter.There was a thin layer of fibrin of leaflets 1 and 2.No acute inflammation or significant calcifications were 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 fibrin, pannus, or tears 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 TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6158284
• MDR Text Key: 61891223
• Report Number: 3001883144-2016-00077
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• 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: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2015
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 4455913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2013
• 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: 76 YR