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

Model Number TF-25A

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Infarction, Cerebral (1771)

Event Date 01/13/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device remains implanted.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.

Event Description

A patient with a history of hyperthyroidism participating in the trifecta durability study was implanted with a 25mm trifecta valve on (b)(6) 2011.On (b)(6) 2011, symptoms required the patient to undergo a cerebral ct which was negative for bleeding or ischemia.A final medical diagnosis was a stroke with left hemiparesis of an unknown etiology.No treatment was listed as being performed.On (b)(6) 2011, the subject was diagnosed with atrial fibrillation.The study site related the event to the procedure, but not to the device.The subject had a final telephone follow on (b)(6) 2015.No additional details are anticipated.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5371466
• MDR Text Key: 36195794
• Report Number: 3001743903-2016-00008
• 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
• Report Date: 04/15/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/27/2012
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 3250560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2011
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2010
• 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: 62 YR