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

Model Number E100-25M

Device Problem Material Perforation (2205)

Patient Problems Calcium Deposits/Calcification (1758); Mitral Regurgitation (1964)

Event Date 05/16/2019

Event Type  Injury  

Event Description

On (b)(6) 2012, a 25 mm epic valve was implanted with non-everting sutures.In (b)(6) 2019, an echocardiogram revealed mitral regurgitation through p1 and p2.On (b)(6) 2019, the device was explanted.Upon explant, the p1 leaflet was observed perforated with thinning leaflets.The patient had mitral annular calcification (mac), so a mitral annular enlargement was performed and a 31 mm epic valve was implanted.An aortic valve replacement was performed concomitantly (25 mm inspiris resilia).The patient is reported to be stable.

Manufacturer Narrative

Explant was reported due to mitral regurgitation.The thinning leaflets seen at explant were confirmed.All three cusps contained marked thinning and loss of collagen fibers.Cusp 3 was torn at the base.No acute inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the tear and thinning could not be conclusively determined.

Event Description

On (b)(6) 2012, a 25mm epic valve was implanted with non-everting sutures.In (b)(6) 2018, an echocardiogram revealed mitral regurgitation through p1 and p2.On (b)(6) 2019, the device was explanted.Upon explant, the p1 leaflet was observed perforated with thinning leaflets.The patient had mitral annular calcification (mac), so a mitral annular enlargement was performed and a 31mm epic valve was implanted.An aortic valve replacement was performed concomitantly (25mm inspiris resilia).

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 8718131
• MDR Text Key: 148650458
• Report Number: 3001883144-2019-00060
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

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: 06/26/2016
• Device Model Number: E100-25M
• Device Catalogue Number: E100-25M
• Device Lot Number: 3807928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 41