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

Model Number TF-19A

Device Problems Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Calcium Deposits/Calcification (1758); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on 28 april a patient had undergone an explant procedure of their 19mm sjm trifecta valve.The valve was originally implanted (b)(6) 2014.During a follow up visit (b)(6) 2020, the patient had undergone an echocardiogram which revealed peak gradient pressures of 75.1 mmhg.While being treated with dialysis (b)(6) 2021, the patient had another echo revealing an even higher peak gradient of 112.6 mmhg.They were given the diagnosis of severe aortic stenosis.A re-do aortic valve replacement (avr) procedure was performed on (b)(6) 2021.The trifecta valve was explanted and replaced with a 19 mm mosaic bio-prothesis (medtronic).Upon explant, calcification was observed from the annulus to the middle part of the leaflets(the lcc was particularly stiff) while the upper part of the leaflets were soft and mobile, functioning.Perforations and tears were not observed.The surgeon and the sales rep.Thought the issue was due to calcification.It was reported that the leaflets and the cuff parts of the valve got damaged upon explant.The patient is in stable condition postoperatively.No further information was provided.

Manufacturer Narrative

Explant was reported due to aortic stenosis and high gradient.The investigation found that all three leaflets had calcifications.All three leaflets had fibrous thickening.All three leaflets had tears that were associated with calcifications.Leaflet 3 had fibrous pannus growth on the inflow surface.There was no inflammation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The calcifications noted could have contributed to the reported stenosis.

• 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: 11887387
• MDR Text Key: 252762283
• Report Number: 3008452825-2021-00263
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• 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: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2015
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 4258367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 45