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

Model Number TF-19A

Device Problem Torn Material (3024)

Patient Problem Aortic Regurgitation (1716)

Event Date 07/03/2017

Event Type  Injury  

Event Description

On (b)(6) 2013, an aortic valve replacement (avr) was performed and this 19mm trifecta valve was implanted.On an unknown date, the patient presented to the hospital with cardiac insufficiency and valvular leakage was suspected.Per report, an echo revealed torn tissue and severe aortic regurgitation.On (b)(6) 2017, after transfer to a different hospital, a re-do avr was performed and the valve was explanted.Findings at explant included: a cusp appeared to have been torn at the commissure between the non-coronary cusp (ncc) and right coronary cusp toward the nadir of the ncc.The torn cusp prolapsed from the stent post causing the cusp to be immobile resulting in leakage and the stent posts appeared slightly deformed/splayed out.Each stent post and the base of each cusp was nearly fully covered with an endothelioid layer differing from pannus.A 19mm trifecta valve was implanted.

Manufacturer Narrative

The results of this investigation concluded that leaflets 1 and 3 contained tears, all three leaflets were fibrotically thickened and a thin layer of pannus ingrowth was present on leaflet 3.No acute inflammation or significant calcifications were found.There was no evidence found to suggest the cause of the tear, fibrin or pannus was 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. (PAMPULHA); 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. (PAMPULHA); 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: 6750817
• MDR Text Key: 81290625
• Report Number: 3001883144-2017-00049
• 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: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2014
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 3704313
• Other Device ID Number: 05414734052016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2012
• 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): Required Intervention
• Patient Age: 83 YR