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

Model Number TF-21A

Device Problems Gradient Increase (1270); Insufficient Information (3190)

Patient Problems Calcium Deposits/Calcification (1758); No Information (3190)

Event Date 11/28/2017

Event Type  Injury  

Event Description

On (b)(6) 2012, a 21mm trifecta valve was implanted.On (b)(6) 2017, the valve was explanted secondary to symptomatic calcification and high gradient.At the time of the implant the bypass time was 122 min and aortic x-clamp was 93 minutes.Additional information has been requested.

Manufacturer Narrative

The reported event of calcification was confirmed.Morphological and histopathological examination revealed calcifications in all three leaflets.Leaflet 1 contained fibrous thickening, all three leaflets contained circumferential fibrous pannus ingrowth which narrowed the inflow diameter, and leaflet 1 was folded in on itself.Leaflet 3 had been excised prior to analysis.No acute inflammation was present in the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown; however, high gradient is consistent with calcified leaflets.

Event Description

On (b)(6) 2012, a 21 mm trifecta valve was implanted.On (b)(6) 2017, the valve was explanted secondary to symptomatic calcification and high gradient.An unknown valve was implanted.At the time of the implant the bypass time was 122 min and aortic x-clamp was 93 minutes.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA.; caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer Contact: 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7147780
• MDR Text Key: 95821758
• Report Number: 3001743903-2017-00049
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/18/2013
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3312970
• Other Device ID Number: 05414734052023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2011
• 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): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 84