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

Model Number TF-23A

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

Patient Problem Aortic Regurgitation (1716)

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) 2016, a 23mm trifecta valve was implanted.4 years post implant the patient presented with aortic regurgitation.On (b)(6) 2020, the valve was explanted and a torn cuff/sewing cuff was noted.A 23mm regent heart valve w/flex cuff was implanted.The patient was reported to be in stable condition.

Manufacturer Narrative

Additional information: d10, h3, h6 explant was reported due to regurgitation.The investigation found that all three leaflets were torn.Leaflets 1 and 3 contained folds.There was circumferential fibrous pannus ingrowth on the inflow surface which extended onto the bases of all three leaflets and fibrous pannus ingrowth on the outflow surface of leaflets 1 and 3.No inflammation was present.A focal calcification was present within the pannus.In the absence of any calcification in relation to the tears 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 the tear sites, which could have contributed to the tear.Furthermore, the pannus noted on the inflow and outflow surfaces 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
• MDR Report Key: 10528082
• MDR Text Key: 206763311
• Report Number: 3008452825-2020-00463
• Device Sequence Number: 1
• Product Code: LWR
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TF-23A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention