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

Model Number TF-25A

Device Problems Backflow (1064); Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problems Calcium Deposits/Calcification (1758); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/26/2021

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 on (b)(6) 2013, a 25mm sjm trifecta valve was implanted in the aortic position due to patient history of aortic regurgitation (ar).The patient has been on dialysis.After the initial aortic valve replacement (avr), the patient had regular yearly follow-ups with echocardiography.In (b)(6) 2020, echo findings confirmed trivial ar and a thickened right coronary cusp (rcc).At that time, the minimal pressure gradient was 11mmhg, and the effective orifice area index (eoai) was 1.04cm2.In (b)(6) 2021, echo findings revealed that ar had deteriorated to moderate to severe grade.The minimal pressure gradient 15mmhg, and the eoai 1.08cm2.All three leaflets were confirmed to be thickened.On (b)(6) 2021, the 25mm trifecta valve was explanted and replaced with a 25mm non-abbott valve.Upon explant, it was observed that there was a leaflet tear from the stent post between the non-coronary cusp (ncc) and the left coronary cusp (lcc).No additional information was provided.

Manufacturer Narrative

Correction: h6 health effect clinical code, added code 1758 - calcium.Deposits/calcification.Explant was reported due to aortic regurgitation, leaflet thickening and a leaflet tear.The investigation found that leaflets 1 and 3 were torn.All three leaflets had fibrous thickening.Calcifications were present in leaflets 1 and 3.There was fibrous pannus ingrowth on the inflow surface of leaflet 2.No acute inflammation was present.It was reported that the patient had been on dialysis.Per the warnings section of ifu artmt100033843 revision c, "accelerated deterioration due to calcific degeneration of the valve may occur in children, adolescents, or young adults.Patients with altered calcium metabolism (e.G., patients with hyperparathyroidism or chronic renal failure).Individuals requiring hemodialysis." 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.Calcification was present in leaflets 1 and 3, which could have induced increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.

Manufacturer Narrative

Update to device evaluation summary: explant was reported due to aortic regurgitation, leaflet thickening and a leaflet tear.The investigation found that leaflets 1 and 3 were torn.All three leaflets had fibrous thickening.Calcifications were present in leaflets 1 and 3.There was fibrous pannus ingrowth on the inflow surface of leaflet 2.No acute inflammation was present.It was reported that the patient had been on dialysis.Per the warnings section of ifu artmt100033843 revision c, "accelerated deterioration due to calcific degeneration of the valve may occur in children, adolescents, or young adults.Patients with altered calcium metabolism (e.G., patients with hyperparathyroidism or chronic renal failure).Individuals requiring hemodialysis." the cause of the tears could not be conclusively determined; however, the calcifications 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 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: 13192772
• MDR Text Key: 288590785
• Report Number: 3014918977-2022-00004
• Device Sequence Number: 1
• Product Code: LWR
• 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,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TF-25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 60 KG