MAUDE Adverse Event Report: ST. JUDE MEDICAL CANADA, INC. TRIFECTA VALVE,IDE,25MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-25A-IDE

Device Problems Gradient Increase (1270); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Calcium Deposits/Calcification (1758); Stenosis (2263)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

Gtin number: unknown.

Event Description

This 25 mm sjm trifecta valve was implanted on (b)(6) 2008.On (b)(6) 2016, calcification, stenosis and an elevated mean gradient were noted via echocardiogram.The valve was explanted on (b)(6) 2016 and replaced with a 27 mm magna ease valve.The patient is reported to be stable.

Manufacturer Narrative

(b)(4).The results of this investigation concluded there was fibrous pannus ingrowth on the inflow surface of all thee cusps, narrowing the inflow diameter.Cusp 3 was fibrotically thickened, and all three cusps contained calcifications.A thin layer of fibrin was observed on the outflow surface of cusp 2.No acute inflammation was observed and gram stains were negative for organisms.No evidence was found to suggest the cause of the fibrin, calcification, and pannus was 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.

Event Description

This 25 mm sjm trifecta valve was implanted on (b)(6) 2008.On (b)(6) 2016, calcification, stenosis and an elevated mean gradient were noted via echocardiogram.The maximum transaortic pressure gradient was 55 mm hg and the average transaortic pressure gradient was 29 mm hg.The valve was explanted on (b)(6) 2016 and replaced with a 27 mm magna ease valve.The patient is reported to be stable.

• Brand Name: TRIFECTA VALVE,IDE,25MM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CANADA, INC.; 2550 blvd. vanier; st. hyacinthe J2S 6 L7; CA J2S 6L7
• Manufacturer (Section G): ST. JUDE MEDICAL CANADA, INC.; 2550 blvd. vanier; st. hyacinthe J2S 6 L7; CA J2S 6L7
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5474106
• MDR Text Key: 39469722
• Report Number: 8020430-2016-00002
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TF-25A-IDE
• Device Catalogue Number: TF-25A-IDE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 74 YR
• Patient Weight: 95