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

Model Number TF-19A

Device Problems Obstruction of Flow (2423); Torn Material (3024)

Patient Problems Corneal Pannus (1447); Aortic Regurgitation (1716)

Event Date 12/22/2017

Event Type  Injury  

Event Description

On (b)(6) 2012, an aortic valve replacement (avr) was performed due to calcification and this 19mm trifecta valve was implanted.The patient's native aortic valve was reported to be bicuspid valve.On an unknown date in 2016, no significant findings were observed during a follow up visit.On an unknown date in (b)(6) 2017, aortic regurgitation (ar) was diagnosed and an echocardiogram revealed an impeded leaflet.On (b)(6) 2017, a re-do avr was performed and this valve was explanted.Ex vivo, it was noted that the non-coronary cusp (ncc) had become torn.A carpentier-edwards perimount magna ease aortic heart valve (size unknown) was implanted.Additional information including the patient's postoperative condition has been requested.

Manufacturer Narrative

The device was returned due to aortic regurgitation and leaflet impedance.Gross morphological and histopathological examination revealed all three leaflets contained tears.There was a thin layer fibrous pannus on the outflow surface of leaflet 2.There was no acute inflammation or significant calcifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2012, an aortic valve replacement (avr) was performed due to calcification and this 19mm trifecta valve was implanted.The patient's native aortic valve was reported to be bicuspid valve.On an unknown date in 2016, no significant findings were observed during a follow up visit.On an unknown date in (b)(6) 2017, aortic regurgitation (ar) was diagnosed and an echocardiogram revealed an impeded leaflet.On (b)(6) 2017, a re-do avr was performed and this valve was explanted.Ex vivo, it was noted that the non-coronary cusp (ncc) had become torn.A carpentier-edwards perimount magna ease aortic heart valve (size unknown) was implanted.The patient has been in stable condition and is recovering.

• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7188753
• MDR Text Key: 97271967
• Report Number: 3008452825-2018-00014
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2014
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 3769963
• Other Device ID Number: 05414734052016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/14/2018
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR