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

Model Number TF-21A

Device Problems Backflow (1064); Structural Problem (2506); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problems Atrial Fibrillation (1729); Heart Failure (2206); Regurgitation (2259)

Event Date 11/15/2019

Event Type  Injury  

Event Description

On (b)(6) 2013, avr, mvr, and tap were performed in which a 21mm trifecta aortic valve, a 27mm epic mitral valve, and an mc3 annuloplasty ring (by edwards lifesciences) were implanted in the patient with a comorbidity of atrial fibrillation.The trifecta valve was implanted by non-everting mattress suturing technique using pledgets.In the beginning of (b)(6) 2019, the patient presented at the hospital with symptom of cardiac failure.Atrial regurgitation was observed in the examination, which was thought to be due to structural valve deterioration of the trifecta valve.On (b)(6) 2019, a re-do aortic valve replacement was performed.The 21mm trifecta valve was explanted and replaced with another 21mm trifecta valve (sn (b)(4)).Upon explant, pannus and leaflet tear were observed.Also, the cusps were observed to be prolapsed from the non-coronary cusp and left coronary cusp stent post parts.Reportedly, the valve got damaged upon explant.The patient is in stable condition after the re-do surgery.

Event Description

On 25 september 2013, aortic valve replacement, mitral valve replacement, and tricuspid annuloplasty were performed in which a 21mm trifecta aortic valve, a 27mm epic mitral valve, and an mc3 annuloplasty ring(by edwards lifesciences) were implanted in the patient with a comorbidity of atrial fibrillation.The trifecta valve was implanted by non-everting mattress suturing technique using pledgets.In the beginning of november, 2019, the patient presented at the hospital with symptom of cardiac failure.Aortic regurgitation was observed in the examination, which was thought to be due to structural valve deterioration of the trifecta valve.On (b)(6) 2019, a re-do aortic valve replacement was performed.The 21mm trifecta valve was explanted and replaced with another 21mm trifecta valve (sn (b)(6)).Upon explant, pannus and leaflet tear were observed.Also, the cusps were observed to be prolapsed from the non-coronary cusp and left coronary cusp stent post parts.Reportedly, the valve got damaged upon explant.The patient is in stable condition after the re-do surgery.

Manufacturer Narrative

The tear seen at explant was confirmed.Leaflet 2 and 3 were torn.There was fibrous pannus ingrowth on the outflow surface of all three leaflets.Leaflets 2 and 3 contained degenerative changes in the tissue of the leaflets.No acute inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the tears could not be conclusively determined, however loss of collagen fibers were noted at the site of one of the tears which could have contributed.In addition, the fibrous pannus ingrowth noted on the outflow surface 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, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 9467447
• MDR Text Key: 181232106
• Report Number: 3001883144-2019-00130
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2014
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3923289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 47