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

Model Number TF-19A

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

Patient Problems Congestive Heart Failure (1783); Dyspnea (1816); Insufficiency, Valvular (1926); Regurgitation, Valvular (2335)

Event Date 09/05/2020

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2013, a 19mm sjm trifecta valve was implanted in the supra-annular position with non-everting mattress suture technique using pledgets.An abbott sizer was used in the surgery.Mild paravalvular leakage(pvl) was confirmed in the first follow-up after the surgery.The patient presented to the hospital due to shortness of breath in mid-july, 2020.Regurgitation and severe pvl were confirmed on echocardiogram.In mid-august, heart failure worsened, and the patient was hospitalized in emergency.The patient recovered once with medication, but on (b)(6) 2020, a semi-emergency re-do avr was performed.The trifecta valve was explanted, replaced with a 19mm inspiris resilia aortic valve(manufacturer: edwards lifesciences).Upon explant, subvalvular pannus formation was observed.Tears were also observed near the rcc and ncc stent post and commissure.It was reported also that the lcc leaflet got damaged upon explant.Although there was mild pvl already confirmed in the first follow-up, the surgeon attributed the issue to the valve from the observation of the explanted valve.Analysis on the cause of the tears were requested from the site.It was confirmed in the examination that the actual cause of the patient's symptom was due to the severe regurgitation due to the tears, not due tot eh pvl grade worsening.

Manufacturer Narrative

Explant was reported due to regurgitation paravalvular leak and worsening heart failure.The investigation found that leaflets 2 and 3 were torn.Leaflet 1 was also torn, and information from the field indicated that leaflet 1 was damaged at explant.There was focal fibrous pannus ingrowth on the inflow of leaflets 1 and 2.No acute inflammation and significant calcifications were present.Stent post 3 was bent.How or when the damage occurred could not be conclusively determined, however it is consistent with damage at explant.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.In the absence of any calcification or evidence for 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.In this case, histological evaluation did find degenerative changes and loss of collagen fibers at the tear site, which could have contributed to the formation of the tear.

• 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: 10627481
• MDR Text Key: 209805356
• Report Number: 3001883144-2020-00088
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2015
• Device Model Number: TF-19A
• Device Lot Number: 4168204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR