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

Model Number TF-19A

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

Patient Problem Valvular Stenosis (2697)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2015, a 19mm sjm trifecta valve was implanted in the patient's aortic position with non-everting mattress suture technique using pledgets in another hospital(national cerebral and cardiovascular center).An abbott sizer was used in the surgery.Severe aortic stenosis thought to be due to calcification was found in the echocardiogram on (b)(6) 2020.On (b)(6) 2020, a re-do avr was performed and the trifecta valve was explanted, replaced with a 19mm magna mitral ease(manufacturer: edwards lifesciences) after performing aortic annular enlargement.Upon explant, a tear on the stent strut part between the lcc and rcc commissure leading vertically to nadir was visually confirmed, thus the surgeon concluded that the issue was not due to the calcification, but due to the tear on the valve in the early stage after the implant.The patient is in stable condition postoperatively.

Manufacturer Narrative

Additional information: d10, h3, h6.Explant was reported due to stenosis.The investigation found that all three leaflets contained tears.Leaflets 1 and 3 contained previous incisions.There was circumferential fibrous pannus ingrowth on the inflow surface which narrowed the inflow diameter.The pannus extended into the bases of leaflets 2 and 3.There was fungal hyphae on the surface of the valve, which was consistent with a contaminant.No 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.The circumferential inflow pannus noted could have contributed to the reported stenosis.The cause of the tear could not be conclusively determined; however, 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, 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: 10270539
• MDR Text Key: 199287701
• Report Number: 3001883144-2020-00069
• 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
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2016
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 5013182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR