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

Model Number	TF-27A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, a 27mm trifecta valve was implanted.On (b)(6) 2018, the valve was explanted.Upon explant, a 3mm tear was observed at the ncc along both stent posts that resulted in prolapse of the leaflet to the ventricle.The valve was replaced with a 27mm edwards perimount magna ease valve and the patient is reported to be discharged.
Additional Manufacturer Narrative
The reported leaflet tears and resultant prolapse was confirmed.Morphological and histopathological examination found leaflets 1 and 3 were torn.Leaflet 3 was torn at both stent posts, resulting in the tissue sliding down, or prolapsing.There was circumferential fibrous pannus ingrowth on the inflow surface and on the outflow surface of leaflet 2, with no evidence of inflammation or significant calcifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the tearing could not be conclusively determined; however, the pannus noted on the inflow and outflow surfaces 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
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8177273
• Report Number: 3008452825-2018-00426
• Device Sequence Number: 11094486
• Product Code: LWR
• UDI-Device Identifier: 05414734052054
• UDI-Public: 05414734052054
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2017
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Device Lot Number: 5245157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention