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

Model Number TF-25A

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

Patient Problems Embolism (1829); Hematoma (1884)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2014, a 25mm trifecta valve was implanted.The valve was reported to be very calcified with rigid sigmoids.On (b)(6) 2019, the valve was explanted and during explanted a traumatic sigmoid tear was reported.The valve was exchanged for 23mm carpentier edwards magna ease valve.Post implant the patient was reported to be stable.Shortly after explant procedure the patient presented with psoas hematoma, lumbar embolization and the patient has a double j catheter stent placed and their ventilation has been extended.The post operative complication are unrelated to the explant procedure.The patient was reported to be in unstable condition.

Manufacturer Narrative

The calcification seen at explant was confirmed.All three leaflets contained calcifications.Leaflets 2 and 3 contained tears which were associated with calcifications.There was circumferential fibrous pannus ingrowth on the inflow surface and on the outflow surface of leaflet 1.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 at the time of commercialization.The cause of the tear could not be conclusively determined; however, the tears were associated with calcifications.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: 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: 9504956
• MDR Text Key: 173336005
• Report Number: 3008452825-2019-00632
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2015
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 4346942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention