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

Model Number TFGT-23A

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

Patient Problems Dyspnea (1816); Endocarditis (1834); Fever (1858); Pleural Effusion (2010); Tachycardia (2095); Cardiogenic Shock (2262); Aortic Valve Insufficiency/ Regurgitation (4450); Cough (4457)

Event Date 06/10/2021

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

This event is being conservatively reported for death as the cause of death is unknown but occurred two days after the trifecta gt valve was explanted and replaced.It was reported that a (b)(6) patient underwent a bentall surgery on (b)(6) 2019 with a 23mm trifecta gt valve and dacron tube.Patient history included: high blood pressure, 4 teeth with periodontal and apical granulomas, aneurysm of the ascending aorta, and atrial fibrillation with cardioversion.On (b)(6) 2021, the patient reported sudden occurrence of insomnia dyspnea and cough and was sent into the er.The patient presented with a fever, and elevated c-reactive protein (crp).The patient was in sinus rhythm and left ventricular hypertrophy with depressed st segment.Lab values reported elevated leukocytes, neutrophils, and troponins.A transesophageal echo (tee) showed a massive aortic insufficiency and left ventricular diastolic dysfunction.A computed tomography (ct) showed pleural fluid effusions associated with ground glass areas prevalent in perihilar areas, possibly an infectious cardiac origin.Infectious endocarditis was suspected.Although initial blood cultures were negative the patient was still on iv antibiotics.It was noted that during pre-operative check-up while still hospitalized, the patient presented with sudden acute lung edema with polypnea and desaturation despite being on high concentration mask.The patient slightly stabilized after receiving non-invasive ventilation, bolus iv furosemide, and iv risordan.Then patient had an episode of supraventricular tachycardia at 180 beats per minute (bpm) requiring and iv cordarone 300mg.The patient became dependent on non-invasive ventilation.Due to their critical condition, urgent surgical intervention was required.The patient was transferred to another hospital.It was noted that the patient did not complete the pre-operative check-up, prior to surgery, that required extraction of 4 teeth.On (b)(6) 2021, the patient underwent an emergency surgery due to massive aortic insufficiency and endocarditis.The trifecta gt valve was explanted from the patient and replaced with a 23mm non-abbott valve.It was noted that there was a tear at the non-coronary cusp (ncc) around the non-coronary left commissure of the trifecta gt valve.There was no sign of infection.The patient was placed in intensive care and died on (b)(6)2021.The cause of death was not reported.No additional information was provided.

Manufacturer Narrative

Explant was reported due to aortic insufficiency.The investigation found that half of leaflets 1 and 2 had been previously excised, along with stent post 2.There was pannus on the inflow of all three leaflets and on the outflow surface of leaflet 2.Leaflet 3 was torn.There was surface fungal hyphae which was interpreted as a contaminant.No inflammation or significant calcifications were present.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 not demonstrate loss of collagen at the tear site.The cause of the tear 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.

Event Description

Subsequent to the initially filed report, the following information was received: the patient was placed in intensive care and died on (b)(6) 2021 due to cardiogenic shock.No additional information was provided.

• Brand Name: TRIFECTA¿ GT 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 01897 -405; CS 01897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 12147564
• MDR Text Key: 260921476
• Report Number: 3014918977-2021-00026
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: 05415067018229
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2022
• Device Model Number: TFGT-23A
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 6573430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2018
• 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): Death
• Patient Age: 68 YR
• Patient Sex: Female