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

Model Number TF-25A

Device Problems Device Dislodged or Dislocated (2923); Gas/Air Leak (2946)

Patient Problem Heart Failure (2206)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2017, a 25 mm trifecta valve was implanted due to endocarditis.Prior to 2 year post implant follow-up the patient was transferred to the hospital for acute heart failure and transvalvular leakage was confirmed.On (b)(6) 2019, the trifecta valve was explanted and exchanged for a 23 mm resilia aortic valve.During explant procedure, it was noted that the left coronary cusp (lcc) was already detached and the valve was detached from the annulus.Trivial paravalvular leakage was confirmed.No patient consequences were reported and the patient was in stable condition.

Manufacturer Narrative

Explant was reported due to mitral regurgitation and cardiac insufficiency.The tear seen at explant was confirmed.All three leaflets contained tears.Fibrous pannus ingrowth was present on the inflow of leaflets 1 and 3 and on the outflow of leaflet 2.No acute inflammation or significant calcifications were present.The cause of the tear and pannus formation could not be conclusively determined; however, the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.

• 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
• MDR Report Key: 8722102
• MDR Text Key: 148763756
• Report Number: 3008452825-2019-00291
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2018
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: BR00007970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR