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 E100-25M

Device Problem Gradient Increase (1270)

Patient Problems Corneal Pannus (1447); Mitral Valve Stenosis (1965); Thrombus (2101)

Event Date 11/09/2017

Event Type  Injury  

Event Description

On (b)(6) 2016, a double valve replacement was performed.Concomitantly, a tricuspid annuloplasty (tap) and maze procedure were performed.A 25 mm epic valve was implanted in the mitral position and a 21 mm trifecta valve in the aortic position.The patient was reported to have undergone regular checkups at another facility.As the patient¿s sinus rhythm was restored to normal after the maze procedure, both warfarin and aspirin were discontinued 3 months postoperatively.On (b)(6) 2017, an echocardiogram was performed and it revealed a mean pressure gradient (mpg) of 30 mmhg with a mitral valve area (mva) of 1.6 cm2.No leakage in aortic, mitral or tricuspid valve was observed at this time.Since (b)(6) 2017, dyspnea on exertion was noted.On (b)(6) 2017, an elevated pressure gradient in both aortic and mitral position and pulmonary hypertension was reported.Additional information received on (b)(6) 2017 indicated the eoa of the mitral valve was stenotic and the eoa of the aortic valve was 0.9cm2 with a pressure gradient of 48mmhg.The trifecta valve appeared to have normal open-close movement.On (b)(6) 2018, re-do mvr was performed.Upon explant of the epic valve, pannus exhibited mildly on the inflow side without impeding mobility of cusps.After the sewing cuff was incised, the molded silicone elastomer and stainless steel wire were removed from the epic valve.The porcine valve cusps with the outermost bovine pericardial tissue strip were separately explanted from the knitted polyester fabric cover of the incised sewing cuff.The porcine valve was noted to be intact.Thrombus adhered throughout all three cusps on the outflow surface, the surgeon deemed that this incident was caused by prosthetic valve failure due to thrombosis.The remaining polyester fabric of the sewing cuff was removed from the mitral position.When the replacement mitral annulus was sized, a 25mm mosaic tissue valve (medtronic) was implanted.The aorta was subsequently incised 3cm from the central side of the initial avr and minimal thrombus was observed at the commissure of the trifecta valve.There was no thrombus nor pannus formation noted on the cusps and no evidence of impeded mobility.The trifecta valve still remains implanted in the patient.The patient¿s postoperative course was uneventful.

Manufacturer Narrative

The reported event of thrombus was confirmed.An elevated pressure gradient, pulmonary hypertension and a stenotic mitral valve was also reported.Morphological and histopathological examination found outflow thrombus on cusp 3, which folded in the free-edge of the cusp.No acute inflammation or significant calcifications were found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown; however, an elevated pressure gradient, pulmonary hypertension and stenosis are consistent with thick, organizing thrombus adhering to the outflow surface, immobilizing the cusp.

• 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: 7188729
• MDR Text Key: 97272327
• Report Number: 3001883144-2018-00010
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2018

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: 07/12/2019
• Device Model Number: E100-25M
• Device Catalogue Number: E100-25M
• Device Lot Number: BR00004063
• Other Device ID Number: 05414734027519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 01/14/2018
• Supplement Dates Manufacturer Received: 02/08/2018
• Supplement Dates FDA Received: 02/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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: 77 YR
• Patient Weight: 59