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

Model Number TF-25A

Device Problem Torn Material (3024)

Patient Problems Aortic Insufficiency (1715); Ventilator Dependent (2395)

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2013, a 25mm trifecta valve was implanted in a patient with multiple co-morbidities.On (b)(6) 2015, the valve was explanted secondary to severe aortic insufficiency which had resulted in the patient requiring intubation.A 23mm sjm supra epic tissue valve was implanted.Ex vivo, a tear was observed from the stent post between the cusp and non-coronary cusp up to the nadir of the left coronary cusp.The patient reportedly remains on a ventilator.

Manufacturer Narrative

Updated, medwatch mw5058255.The results of this investigation concluded cusps 2 and 3 contained tears.There was fibrous pannus ingrowth on the inflow surface of all three cusps.There was a thin layer of fibrin on the surface all cusps.Special stains were negative for organisms and no acute inflammation or significant calcifications were present.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, pannus, or tear was due to an intrinsic defect in the valve, as supported by the analysis performed.The cause of the reported event remains unknown.

Event Description

Per report, there was also a small strand of suture that was broken on the stent post between the left coronary cusp and the non-coronary cusp.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 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: 5294521
• MDR Text Key: 33424084
• Report Number: 3007113487-2015-00050
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

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: 05/06/2015
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 4088587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2013
• 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: 64 YR
• Patient Weight: 127