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

Model Number TF-21A

Device Problem Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2010, a 21 mm trifecta valve was implanted.On (b)(6)2016, the valve was explanted and replaced with a 25 mm medtronic freestyle valve due to degeneration of the valve.The patient is reported to be stable.

Manufacturer Narrative

(b)(4).The results of this investigation concluded all three leaflets contained calcifications and were fibrotically thickened.There was fibrous pannus ingrowth on the inflow surface of leaflets 1 and 2.All three leaflets were unable to coapt properly.No inflammation was observed in the valve.A review of the device history record showed the device met specifications prior to leaving sjm manufacturing facilities.There was no evidence found to suggest the cause of the fibrin, calcifications, and pannus were due to an intrinsic defect in the valve, as supported by the analysis performed.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2010, a 21 mm trifecta valve was implanted.On (b)(6) 2016, the valve was explanted and replaced with a 25 mm medtronic freestyle valve due to calcification and aortic insufficiency.The patient is reported to be stable.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5869683
• MDR Text Key: 51886564
• Report Number: 3007113487-2016-00038
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PP100029
• 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: 07/18/2016

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: Health Professional
• Device Expiration Date: 07/24/2012
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3181790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 08/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR