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

Model Number TF-21A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Insufficiency (1715); Calcium Deposits/Calcification (1758); Pulmonary Edema (2020); Cusp Tear (2656)

Event Type  Injury  

Event Description

A 21mm trifecta tissue valve was implanted on (b)(6) 2010 to treat the patient's aortic insufficiency.The patient's native aortic valve was severely calcified and excised prior to implant.One week post-implant, a transesophageal echo (tee) showed a peak/mean gradient of 18mm/8mm hg respectively without aortic regurgitation.In 2014, a routine echocardiography confirmed a normal, functioning aortic valve.In (b)(6) 2015, the patient presented with acute pulmonary edema due to severe aortic insufficiency caused by a reported tear in the cusp adjacent to the right coronary.On (b)(6) 2015, a tee was performed due to the potential for endocarditis; the tee revealed a possible tear or prolapse of the anterior cusp.Cultures performed (b)(6) 2015 were negative for bacteria.The valve was explanted (b)(6) and at the time of explant, the annulus was noted to be calcified.A 23mm non-sjm valve was implanted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of the investigation concluded circumferential fibrous pannus ingrowth on the inflow surface narrowing the inflow diameter to 14-15 mm, and a tear in cusps 1 and 2.There was no evidence of acute inflammation and special stains were negative for organisms.No evidence was found to suggest the cause of the pannus and tearing 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 resulting in explant remains unknown.

• 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 3400 0-00; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 3400 0-00; BR 34000-000
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4650357
• MDR Text Key: 5600659
• Report Number: 3001743903-2015-00017
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P100029
• 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: 03/11/2015

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: 10/11/2012
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3240733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 04/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2010
• 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: 83 YR