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

Model Number TF-21A-IDE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Atrial Fibrillation (1729); Calcium Deposits/Calcification (1758); Chest Pain (1776)

Event Date 02/02/2015

Event Type  Injury  

Event Description

The patient underwent implantation of a 21mm trifecta valve in 2008.Approximately 7 years later, on (b)(6) 2015, the patient reported with onset of atrial fibrillation and chest pain.On angiography, aortic valve calcification was noted.The patient was scheduled for a tavi valve-in valve on (b)(6) 2015.

Manufacturer Narrative

Gtin: unknown.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CANADA, INC.; 2550 blvd. vanier; st. hyacinthe J2S 6L7; CA J2S 6L7
• Manufacturer (Section G): ST. JUDE MEDICAL CANADA, INC.; 2550 blvd. vanier; st. hyacinthe J2S 6L7; CA J2S 6L7
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4614743
• MDR Text Key: 22250483
• Report Number: 8020430-2015-00001
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2015

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: 03/12/2009
• Device Model Number: TF-21A-IDE
• Device Catalogue Number: TF-21A-IDE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 03/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2008
• 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: 77 YR
• Patient Weight: 76