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

Model Number TF-23A

Device Problem Perivalvular Leak (1457)

Patient Problem Cusp Tear (2656)

Event Date 10/27/2014

Event Type  Injury  

Event Description

A minimally invasive aortic valve replacement procedure was performed due to a stenotic, calcified native aortic valve with this 23 mm sjm trifecta valve.The corknot device was used for suturing single button, felt-armed u-sutures.At discharge, valvular leakage was observed.The valve was explanted and a semi-circular tear was observed on the left coronary cusp.The valve was replaced with 23 mm bioprosthesis from another manufacturer.The patient was reported to be in good condition.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of this investigation concluded there was a cut at the base of stent post 1, a nick at the base of stent post 2, a notch in cusp 1, a cut in stent post 3, and both a tear and a cut in cusp 2.There was no evidence found to suggest the cause of the observed damage 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 observed gouge, nick, cuts, and tear remains unknown.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; 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 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4280829
• MDR Text Key: 5010834
• Report Number: 3008452825-2014-00048
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PP100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2016
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 4746562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 11/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2014
• 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: 67 YR
• Patient Weight: 53