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

Model Number TF-23A

Device Problem Torn Material (3024)

Patient Problem Apnea (1720)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2014, a 23 mm trifecta valve was implanted.The patient presented on (b)(6) 2016 with complaints of decompensation and apnea.The trifecta valve was explanted and per report a leaflet tear was identified.A redo avr was performed with implantation of a 23 mm carpentier-edwards magna perimount valve.Due to tricuspid valve prolapse, a concomitant tvr was performed and a 33 mm epic valve was implanted.The patient is reported to be recovering.

Manufacturer Narrative

The results of this investigation concluded that all three leaflets were fibrotically thickened.Circumferential fibrous ingrowth was observed on the inflow side which narrowed the inflow diameter, and extended on to the base of leaflets 1 and 2.Calcifications were observed within detached pannus found adjacent to leaflets 2 and 3.A tear was observed in the base of leaflet 2, and a horizontal fold was observed in leaflet 1.No acute inflammation was observed.No evidence was found to suggest the cause of the fibrous thickening, pannus, tear, fold, and calcifications 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, 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: 6165544
• MDR Text Key: 62080598
• Report Number: 3008452825-2016-00173
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2016
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 4490173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2014
• 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: 70 YR