MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA EPIC STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number CVD0029

Device Problem Insufficient Information (3190)

Patient Problems Thrombosis (2100); Stenosis (2263)

Event Date 03/06/2015

Event Type  Injury  

Event Description

It was reported verbally that an epic mitral tissue valve was explanted six weeks post-implant due to cuspal mobility and stenosis caused by what appeared to be a thrombosis on the cusps.The valve was sent to pathology at the hospital where endocarditis was confirmed.The valve was returned to sjm for further investigation.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of this investigation concluded the valve had been previously dissected.There was focal outflow thrombus on cusps 1 and 2, and a thin layer of fibrin on all cusps.Special stains were negative for organisms, and no significant calcifications or vegetations were present.The thrombi described in the clinical history were not present in this previously dissected valve.No compelling evidence of infectious endocarditis was seen.This may have been an effect of treatment vs.Artifact of prior processing/dissection.There was no evidence found to suggest the cause of the fibrin and thrombus were 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 remains unknown.

Event Description

It was reported verbally that an epic mitral tissue valve was explanted six weeks post-implant due to cuspal mobility and stenosis caused by what appeared to be a thrombosis on the cusps.The valve was sent to pathology at the hospital and will be returned to sjm after completion of internal pathology for further investigation.

Manufacturer Narrative

Unknown as serial and lot numbers are unknown.

• Brand Name: EPIC STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4650406
• MDR Text Key: 5768919
• Report Number: 3001883144-2015-00012
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,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 Model Number: CVD0029
• Was Device Available for Evaluation?: Yes
• 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; Not provided
• Supplement Dates FDA Received: 05/04/2015; 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2014
• 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: 49 YR