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

Model Number TF-19A

Device Problems Calcified (1077); Obstruction of Flow (2423)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Hemolytic Anemia (2279)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2013, a 19mm sjm trifecta valve was implanted due to congenital aortic bicuspid valve.Additionally, the patient had mitral regurgitation and mitral valve annuloplasty and the ascending aortic replacement procedures done at the same time.In (b)(6) 2019, the patient developed anemia following a transverse colectomy.In (b)(6) 2019, aortic stenosis occurred with peak gradient as 64mmhg; the patient was asymptomatic and was monitored.However, the peak gradient increased to 77mmhg with a mean pg of 48mmhg.Therefore, on (b)(6) 2020, the patient underwent re-do aortic valve replacement (avr) and the trifecta valve was explanted due to hemolytic anemia.Upon explant, pannus formation on the lcc and ncc inflow sides and sclerosis due to calcification of the leaflets were confirmed.A new 17mm sjm regent heart valve was successfully implanted.The patient was reported to be in stable condition.

Manufacturer Narrative

Explant was reported due to hemolytic anemia.Also reported was stenosis, pannus and calcifications.The investigation found that all three leaflets contained calcifications.There was circumferential fibrous pannus ingrowth on the inflow surface which extended onto the base of all three leaflets.On the outflow surface, pannus extended onto leaflet 3.All three leaflets had fibrous thickening.Leaflet 3 contained a tear or excised tissue at the free edge.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.

• 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: 11004340
• MDR Text Key: 221477141
• Report Number: 3001883144-2020-00118
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2014
• Device Model Number: TF-19A
• Device Lot Number: 3784821
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 02/17/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 47