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

Model Number	TF-27A
Medical Device Problem Codes	Backflow (1064); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Dyspnea (1816); Regurgitation, Valvular (2335); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2015 a 27mm trifecta valve was implanted.In (b)(6) 2020 the patient came back to cardiologist complaining of shortness of breath and after examination with echo, the aortic regurgitation was observed.On (b)(6) 2020 the valve was explanted.Upon explanted a non-coronary cusp leaflet tear was diagnosed.The procedure was completed by implanting a non-abbott valve (magna ease).The patient is in icu.There was no clinically significant delay in the procedure.The patient remained stable through out and post procedure.
Additional Manufacturer Narrative
The tear observed at explant was confirmed.All three leaflets contained tears, with leaflets 1 and 2 completely torn away from stent post 2, which was bent outwards.Stent post 1 was also bent.Focal degenerative changes were noted in all three leaflets.Outflow tissue ingrowth covered the outflow surface of stent posts 1 and 2.No acute inflammation or significant calcifications were found.The device history record was reviewed to ensure each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.In the absence of any calcification or evidence of infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.Histological evaluation revealed thinning and loss of collagen at two of the tear sites, which could have contributed to the tear.Furthermore, the tissue noted on the outflow surface was possible evidence of interaction with the aortic wall, and 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
• Common Device Name: 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
• MDR Report Key: 10878391
• Report Number: 3008452825-2020-00663
• Device Sequence Number: 2895710
• Product Code: LWR
• UDI-Device Identifier: 05414734052054
• UDI-Public: 05414734052054
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2015
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Device Lot Number: 4278485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR