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

Model Number TF-21A

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

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Pleural Effusion (2010); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 07/19/2021

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 (b)(6) 2021 a patient had underwent a implant procedure of a 21 mm trifecta valve on (b)(6) 2012 due to a bicuspid valve congenital defect and calcification.On (b)(6) 2021 during a follow-up in the clinic the patient presented with difficulties breathing, a pleural effusion and complained of insomnia.A echocardiogram (echo) was performed indicating aortic stenosis (as) along with aortic regurgitation.On (b)(6) 2021 the patient underwent an explant procedure of the 21 mm trifecta valve.Upon explant, it was reported that the stitched part of the outer side of the stent post appeared torn.The valve may have been torn due to the backflow from the diastolic aorta.The echo exam had revealed information indicating as.The surgeon was surprised that there was no calcification or pannus appreciated upon explant.The valve was replaced with a 19 mm epic supra valve w/flexfit.The surgeon is requesting a product analysis.It was reported that little to no cuff remain on the valve because the cuff was cut off with a scalpel during the explant.Also, the stent post between the left coronary cusp (lcc) and the right coronary cusp (rcc) was gripped at the time of explant so the stent post is bent outward.The patient remained stable throughout the procedure and postoperatively.No additional information has been provided.

Event Description

Subsequent to the initially filed information, the following information has been updated."a patient had underwent an implant procedure of a 21 mm trifecta valve on (b)(6) 2012.".

Manufacturer Narrative

Explant was reported due to aortic stenosis, aortic regurgitation, and "the stitched part of the outer side of the stent post appeared torn".The investigation found that there was circumferential fibrous pannus ingrowth on the inflow surface, with narrowing of the inflow diameter.Leaflet 2 and leaflet 3 were torn, with degenerative changes to the leaflet tissue.Leaflet 2 and leaflet 3 had fibrous thickening.Leaflet 2 contained microcalcifications.There was no acute inflammation.Stent post 3 was bent outward at the time of explant.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the tears could not be conclusively determined; however, the degenerative changes noted to the tissue could have contributed to the tear formation; and one of the tears was associated with calcifications.In addition, 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.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12347817
• MDR Text Key: 267449176
• Report Number: 3007113487-2021-00017
• 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
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2013
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3636236
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2011
• 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: 72 YR
• Patient Sex: Male