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

Model Number TF-25A

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 04/09/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, a 25mm trifecta valve was removed in the initial implant procedure as a trans-esophageal echo showed a leak (non-pvl) at the commissure.A 25mm non-sjm valve was implanted.The patient was extubated after surgery.Due to the prolonged pump time, the patient required reintubation, a blood transfusion, ionotropic medications and an extended icu stay.The patient was later discharged and is reported to be doing well.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of the investigation concluded the sewing cuff was slightly ovalized, cusps 1 and 3 contained what appeared to be forceps marks, and cusp 2 contained a fold.A review of the device history record confirmed the valve met all visual, dimensional, and functional tests and inspections at the time it was manufactured, prior to shipment.There was no evidence found to suggest there was 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 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 ; 6517564470
• MDR Report Key: 4758358
• MDR Text Key: 5784067
• Report Number: 3008452825-2015-00027
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100029
• 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: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/15/2016
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 4685097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 05/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2014
• 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: 75 YR