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 E100-29M

Device Problem Torn Material (3024)

Patient Problem Mitral Insufficiency (1963)

Event Date 09/17/2017

Event Type  Injury  

Event Description

On (b)(6) 2015, a mitral valve replacement (mvr) was performed due to mitral stenosis and this 29 mm epic valve was implanted in a patient who required dialysis due to removal of a kidney.All native anterior cusps was removed however, the posterior cusp was saved.In order to keep the shape of the left ventricle, chordae tendineae were reconstructed by artificial tissue.Concomitantly, a maze procedure and tricuspid annuloplasty were performed.On (b)(6) 2017, the patient presented to the emergency room and an echocardiography revealed a leaflet tear.On (b)(6) 2017, the epic valve was explanted and replaced with an on-x mechanical heart valve (size and serial unknown, senko medical instrument mfg.Co.Ltd.).Reportedly, upon explant, a leaflet tear was found and prolapsed from the stent post at the p2 position toward the p1 side.No significant pannus ingrowth was observed.The patient was reported to be in stable condition post-operatively.

Manufacturer Narrative

The reported event of a cusp tear was confirmed.Gross morphological and histopathological examination revealed cusps 2 and 3 contained tears.There was marked thinning and loss of collagen fibers in cusp 3.There were focal calcifications on the sewing cuff.There was no inflammation present in the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event is consistent with marked thinning and loss of collagen fibers and tears however, the exact cause 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: 6950651
• MDR Text Key: 89348389
• Report Number: 3001883144-2017-00071
• 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: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2018
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: 5068601
• Other Device ID Number: 05414734027533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2014
• 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: 71 YR