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

Model Number	TF-29A
Medical Device Problem Codes	Backflow (1064); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020 dr.(b)(6) information sjm that he was explanting a trifect valve that was implanted approximately 6 years ago.The patient was experience distress.An echo was performed that revealed the patient was suffering from wide open aortic insufficiency due to a possible leaflet tear.It was confirmed upon explant the leaflet was torn.The patient is currently stable.
Additional Manufacturer Narrative
Additional information: d10, h3, h6.Explant was reported due to aortic insufficiency.The investigation found that all three leaflets contained calcifications.There was circumferential fibrous pannus ingrowth on the inflow surface which extended onto the base off all three leaflets.Leaflet 1 had fibrous pannus ingrowth on the outflow surface at the base of the leaflet.Leaflet 3 was torn.All three leaflets had fibrous thickening.No acute 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 cause of the tears could not be conclusively determined; however, all of the tears were associated with calcifications.

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• MDR Report Key: 10211294
• Report Number: 3008452825-2020-00331
• Device Sequence Number: 19651181
• Product Code: LWR
• UDI-Device Identifier: 05414734052061
• UDI-Public: 05414734052061
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2013
• Device Model Number: TF-29A
• Device Catalogue Number: TF-29A
• Device Lot Number: 3744650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/11/2020
• 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