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

Model Number TFGT-19A

Device Problems Backflow (1064); Biocompatibility (2886); Material Split, Cut or Torn (4008)

Patient Problems Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported that a 19mm trifecta gt valve was implanted with uninterrupted suture technique on (b)(6) 2016.Postoperatively, periodic check up was performed yearly with no issues reported a that time.A mild regurgitation revealed on echocardiogram (echo) on (b)(6) 2019.The patient did not have any subjective symptom at that time.Asr and moderate regurgitation and 4.0 m/s velocity were pointed out by the echo on (b)(6) 2020.The patient complained a shortness of breath on exertion at this time.It was found out that aortic regurgitation ( ar) became deteriorated into severe by echo examination performed on (b)(6) 2021.There ware subjective symptom brought from cardiac decompensation.The redo was conducted on (b)(6) 2021.The 19mm tfgt was explanted and a non abbott valve was implanted.The patient remained hemodynamically stable throughout the procedure and has been gradually recovering after the surgery.The leaflet was torn from the stent post between non-coronary cusp (ncc) and right-coronary cusp (rcc ).Circumferential pannus proliferation was confirmed subvalvular.No additional information was provided.

Event Description

It was reported that a 19mm trifecta gt valve was implanted with uninterrupted suture technique on (b)(6) 2016.Postoperatively, periodic check up was performed yearly with no issues reported a that time.A mild regurgitation revealed on echocardiogram (echo) on (b)(6) 2019.The patient did not have any subjective symptom at that time.Asr and moderate regurgitation and 4.0 m/s velocity were pointed out by the echo on (b)(6) 2020.The patient complained a shortness of breath on exertion at that time.It was found out that aortic regurgitation ( ar) became deteriorated into severe by echo examination performed on (b)(6) 2021.There were subjective symptom brought from cardiac decompensation.The redo was conducted on (b)(6) 2021.The 19mm tfgt was explanted and a non abbott valve was implanted.The patient remained hemodynamically stable throughout the procedure and has been gradually recovering after the surgery.The leaflet was torn from the stent post between non-coronary cusp (ncc) and right-coronary cusp (rcc ).Circumferential pannus proliferation was confirmed subvalvular.

Manufacturer Narrative

Explant was reported due to aortic regurgitation.The investigation found that leaflet 1 and leaflet 2 were torn.There was no inflammation or significant calcifications.One photo containing five images was received from the field which appeared to show an explanted tissue valve with a torn leaflet and excised circumferential white tissue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.In the absence of any calcification or evidence for 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.In this case, histological evaluation did demonstrate loss of collagen at one of the tear sites, which could have contributed to the formation of the tear.Also, the reported 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: TRIFECTA¿ GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12719572
• MDR Text Key: 279022098
• Report Number: 3014918977-2021-00082
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018205
• UDI-Public: 05415067018205
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2018
• Device Model Number: TFGT-19A
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 5592694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• 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): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female