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

Model Number TF-29A

Device Problem Torn Material (3024)

Patient Problems Dyspnea (1816); Thrombus (2101)

Event Date 06/23/2017

Event Type  Injury  

Event Description

On (b)(6) 2015, a 29 mm trifecta valve was implanted due to aortic insufficiency.On (b)(6) 2017, the patient developed acute dyspnea.The patient was treated with antibiotics, vancomycin and gentamycin.A pet scan was performed and no abnormalities were seen.On (b)(6) 2017, the valve was explanted and one of the valve leaflets was noted to be torn at the base.There was also suspicion of thrombus on the right cusp.The patient received a smaller 25 mm magna ease valve due to the shortening of the annulus.The patient is reported to be stable.

Manufacturer Narrative

The results of this investigation concluded leaflet 2 contained a tear.There was circumferential fibrous pannus ingrowth on the inflow surface with narrowing of the inflow diameter.There was no inflammation or significant calcifications present in the valve.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.There was no evidence found to suggest the cause of the pannus and tear were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: 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 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); 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: 6728117
• MDR Text Key: 80539448
• Report Number: 3008452825-2017-00159
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2017
• Device Model Number: TF-29A
• Device Catalogue Number: TF-29A
• Device Lot Number: 4994660
• Other Device ID Number: 05414734052061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• 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: 52 YR