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

Model Number TF-19A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Aortic Insufficiency (1715); Pulmonary Edema (2020)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2011, a 19 mm trifecta valve was implanted.On (b)(6) 2016, the patient presented to the hospital in pulmonary edema.The non-coronary cusp was noted to be detached from the prosthesis stent which caused aortic insufficiency.No endocarditis or paravalvular leaks were found and the suture was intact and solid.The trifecta valve was explanted and replaced with a 17 mm regent mechanical heart valve.The patient is reported to be stable.

Manufacturer Narrative

(b)(4).The results of this investigation concluded there were two tears in cusp 3.Special stains were negative for organisms and no acute inflammation or significant calcifications were present.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 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. (NOVA LIMA); caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5657800
• MDR Text Key: 45281815
• Report Number: 3001743903-2016-00032
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2013
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 3488485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2011
• 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: 80 YR