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 E100-25A

Device Problem Torn Material (3024)

Patient Problem Aortic Regurgitation (1716)

Event Date 05/30/2017

Event Type  Injury  

Event Description

On (b)(6) 2013, a bentall procedure was performed and this 25 mm epic valve was implanted in the aortic position.In (b)(6) 2017, signs of prosthetic valve endocarditis (pve) were observed.On an unknown date, aortic regurgitation (ar) was reported and a leaflet tear and vegetation were suspected although the tear was not confirmed on echo.No bacterium was detected.During a redo procedure on (b)(6) 2017, the three cusps were removed; however, the stent post was left in place as the physician believed the native annulus was too vulnerable to remove the entire epic valve.A 16 mm ap360 ats mechanical valve was implanted within the epic stent frame.Ex vivo, neither thrombus nor vegetation was present although per report, each commissure appeared brown in color.Also, a tear between the ncc and lcc toward the nadir of the ncc was observed prior to explant.

Manufacturer Narrative

The results of the investigation concluded there was fibrous thickening of all three cusps.No acute inflammation or significant calcifications were present in the cusps.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 fibrin 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. (PAMPULHA); 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: 6653015
• MDR Text Key: 77927864
• Report Number: 3001883144-2017-00034
• 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: 07/19/2017

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: 04/04/2017
• Device Model Number: E100-25A
• Device Catalogue Number: E100-25A
• Device Lot Number: 4085338
• Other Device ID Number: 05414734027373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/20/2017
• Supplement Dates Manufacturer Received: 05/30/2017
• Supplement Dates FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2013
• 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