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

Model Number TF-19A

Device Problem Torn Material (3024)

Patient Problems Aortic Regurgitation (1716); Death (1802)

Event Date 04/24/2018

Event Type  Death  

Event Description

On (b)(6) 2013, an aortic valve replacement (avr) was performed with a 19 mm trifecta valve.In (b)(6) 2018, the patient presented cardiac failure due to severe aortic regurgitation (ar).An echocardiogram was performed and perivalvular leakage (pvl) was diagnosed.The physician believed the best procedure for treatment was to use vascular plugs to stop the pvl.On (b)(6) 2018, the physician attempted to close the pvl with vascular plug devices, but the leakage could not be controlled.Eventually, the procedure was aborted with the trifecta valve still in the patient.It is reported the patient later expired.The physician believes "as the patient's general condition had deteriorated prior to the procedure, it most likely related to her death." an autopsy was performed and pathological analysis on the valve performed.When the valve was explanted from the patient, the right coronary cusp and left coronary cusp was noted to have been torn.According to the physician, the tear sites were likely enlarged during the deployment procedure of the vascular plugs.Information on the manufacturer of the vascular plugs were not provided.

Manufacturer Narrative

An event of perivalvular leakage was reported.The reported leaflet tears were confirmed.All 3 leaflets contained tears.Fibrous pannus ingrowth was observed focally on the inflow surface of leaflet 1.No inflammations or significant calcifications were found to be present.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.The reported event remains unknown.

Event Description

On (b)(6) 2013, an aortic valve replacement (avr) was performed with a 19 mm trifecta valve.In (b)(6) 2018, the patient presented in cardiac failure due to severe aortic regurgitation (ar).An echocardiogram was performed and perivalvular leakage (pvl) was diagnosed.The physician believed the best procedure for treatment was to use vascular plugs off-label to stop the pvl.On (b)(6) 2018, the physician attempted to close the pvl with five vascular plug devices (2 of model 9-avp2-006; 2 of model 9-avp2-008 and 1 of model 9-avp2-012) however; the pvl was unable to be controlled (stopped) and the procedure was aborted.There was no impact to the pvl or the implanted tricuspid valve.Information was not provided on whether the vascular plugs were left within the patient or removed.It was reported that a later point in time, the patient expired.The physician reported that "as the patient's general condition had deteriorated prior to the procedure, it most likely related to her death." an autopsy was performed and pathological analysis on the valve performed.When the valve was explanted from the patient, the right coronary cusp and left coronary cusp was noted to have been torn.Evidence of pvl was not confirmed and it was not possible to confirm the time of the valve tears.According to the physician, the tear sites were likely enlarged during the deployment procedure of the vascular plugs.No additional information including the serial number and implant date of this valve was made available despite abbott request.Patient specific information on patient identifier and weight are not available for this complaint.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7540381
• MDR Text Key: 109125347
• Report Number: 3001883144-2018-00044
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2015
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 4155643
• Other Device ID Number: 05414734052016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2013
• 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): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR