MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-27M

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problem Mitral Regurgitation (1964)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2013, a mitral valve replacement (mvr) was performed and this 27 mm epic valve was implanted utilizing everting mattress sutures.Reportedly, the patient's native posterior mitral valve leaflet was preserved at the time of surgery.Since the beginning of 2017, mitral regurgitation (mr) was noted.On (b)(6) 2017, a re-do mvr was performed and at explant a tear was observed from the site of suture placement at the stent post toward the nadir of the anterior leaflet side.Another 27 mm epic valve (model: e100-27m, s/n: unknown) was implanted.The patient has been in stable condition postoperatively.

Manufacturer Narrative

The results of this investigation concluded there were degenerative changes in cusps 1 and 3, and cusp 1 contained one tear.There was organizing thrombus with focal acute inflammation on the sewing cuff of cusp 3.Gram and gms stains were negative for organisms.No significant calcifications were present in the valve.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.There was no evidence found to suggest the cause of the tear 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 remains unknown.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6646941
• MDR Text Key: 77744974
• Report Number: 3001883144-2017-00033
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• 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: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2016
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 3810902
• Other Device ID Number: 05414734027526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2012
• 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: 74 YR