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

Model Number TF-21A

Device Problem Torn Material (3024)

Patient Problem Aortic Insufficiency (1715)

Event Type  Injury  

Event Description

On (b)(6) 2013, a 21mm trifecta valve was implanted in the patient's aortic position.In (b)(6)2018, the patient was admitted to the hospital with cardiac failure and leakage was confirmed by follow-up echocardiography.On (b)(6) 2018, the valve was explanted and replaced with a 21mm carpentier-edwards perimount magna ease valve.Upon explant of the trifecta valve, there were vertical tears on the right coronary cusp (rcc) and a left coronary cusp (lcc) from the respective stent post.Intima was slightly observed on the inflow side but it did not reach to each cusps and no pannus formation was noted.The patient is reported to be stable.

Manufacturer Narrative

The 21mm trifecta valve was received in the product performance engineering lab in solution within a device return kit.The valve was grossly and microscopically examined.The sewing cuff was intact and contained blood/body fluids, white tissue, tan tissue and sutures.Leaflet 1 contained a tear along the base and continuing to the stent post shared with leaflet 2.Leaflet 2 contained a tear near the free edge that continued to the stent post shared by leaflet 1.A second tear at the base of leaflet 2 was noted that continued to the stent post shared with leaflet 3.The leaflets were mobile when manually manipulated.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7642194
• MDR Text Key: 112477088
• Report Number: 3001883144-2018-00056
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2014
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3890790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2012
• 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: 68 YR