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

Model Number TF-23A

Device Problems Calcified (1077); Microbial Contamination of Device (2303); Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758)

Event Date 09/21/2017

Event Type  Injury  

Event Description

On (b)(6) 2012, a 23 mm trifecta valve was implanted.On (b)(6) 2017, the valve was explanted secondary to reports of calcification.Per report, the aortic annulus was reconstructed and a 23 mm carpentier edwards magna ease valve was implanted.

Manufacturer Narrative

The reported event of calcification was confirmed.Gross morphological and histopathological examination revealed calcifications, fibrous thickening and fibrous pannus ingrowth on all three leaflets.Stent post 3 and the stent were also bent.No acute inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was 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: 6958188
• MDR Text Key: 89607230
• Report Number: 3008452825-2017-00250
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/15/2017

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: Physician
• Device Expiration Date: 03/21/2014
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3678284
• Other Device ID Number: 05414734052030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 10/23/2017
• Supplement Dates FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR