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

Model Number TF-23A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Aortic Insufficiency (1715)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This 23 mm sjm trifecta valve was implanted on (b)(6) 2013.The valve was explanted on (b)(6) 2015 due to aortic insufficiency and replaced with a non-sjm valve.

Manufacturer Narrative

(b)(4).The results of this investigation concluded there was fibrous pannus ingrowth on the inflow surface of cusps 2 and 3.All three cusps were fibrotically thickened and contained small calcifications.The outflow surface of cusp 1 contained focal organizing thrombus.There was no evidence of acute inflammation and gram stains were negative for organisms.No evidence was found to suggest the cause of the pannus, calcification, fibrin and thrombus formation 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 (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5145571
• MDR Text Key: 28077994
• Report Number: 3008452825-2015-00090
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Followup
• Report Date: 09/15/2015

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: 05/15/2014
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3719001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR