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

Model Number TF-21A

Device Problems Calcified (1077); Obstruction of Flow (2423); Patient-Device Incompatibility (2682)

Patient Problems Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that on (b)(6) 2013, a 21mm sjm trifecta valve was implanted in the patient's aortic position.Around 2018, the patient began showing signs of aortic stenosis(as), and ended up going into heart failure.On (b)(6) 2021, the patient presented with moderate stenosis, cardiac insufficiency, and a high gradient.The sjm trifecta valve was explanted and replaced with a 21mm non-abbott device to resolve the event.Upon explant, calcification was confirmed mainly in the non-coronary cusp (ncc), but other leaflets were confirmed to have generally sclerosed as well.Struts of the ncc part were confirmed to have adhered to the valsalva wall.There was a pannus-like ingrowth at the adhered part, but the ingrowth had not caused the leaflet dysfunction.The patient remained hemodynamically stable throughout the procedure.The patient is in stable condition postoperatively.No additional information was reported.

Manufacturer Narrative

Explant was reported due to stenosis, cardiac insufficiency and high gradient.The calcifications and pannus noted at explant were confirmed, with all three leaflets containing calcifications and fibrous pannus ingrowth on the inflow surface.All three leaflets had fibrous thickening and contained tears.Two of the tears were associated with calcifications, while the other tear had marked degenerative changes including a denatured appearance to the collagen present at the tear site.No inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The calcifications and pannus noted could have contributed to the reported stenosis and the tears found in the valve.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12378868
• MDR Text Key: 268519082
• Report Number: 3001883144-2021-00121
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• 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: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2014
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3979439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female