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 E100-31M

Device Problems Calcified (1077); Off-Label Use (1494); Material Puncture/Hole (1504); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Mitral Valve Stenosis (1965)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2011 the initial mvr was performed on a patient with comorbidity of marfan's syndrome.In 2014 a bentall procedure along with a re-do mvr was performed in which the epic stented porcine heart valve w/flexfit system was implanted in the patient's mitral position.On (b)(6) 2020 a re-do double valve replacement(dvr) was performed due to calcification on both the epic valve and the prosthetic aortic valve(magna mitral ease by edwards lifesciences).The epic valve was replaced with a 31mm sjm masters series heart valve w/teflon cuff (serial#: (b)(4)) while the magna mitral ease valve was replaced with a 21mm sjm regent heart valve w/flex cuff (serial#: (b)(4)).Upon explant, pannus formation and a perforation were observed on the leaflets of the epic valve.Diagnosis on the epic valve before the dvr was moderate stenosis, which was thought to be caused by the pannus on the leaflets.As for the aortic valve, two of the leaflets have calcified and were fused.The patient was stable post procedure.

Manufacturer Narrative

Additional information for: g4, g7, h2, h3, h6, and h10 the pannus and perforation seen at explant were confirmed.The investigation found calcification on all three cusps which immobilized the cusps.Cusp 2 contained a perforation, which was associated with a calcification.There was circumferential fibrous pannus ingrowth on the outflow surface, with fusion of the commissures and which limited the mobility of the cusps.There was fibrous pannus on the inflow of cusps 1 and 2.Folds were present in the base of cusp 1.No acute inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The calcifications, pannus, and fusions of the commissures would have contributed to the reported stenosis.Please note, per the instructions for use, artmt 100110484 revision a"safety and effectiveness of the st.Jude medical stented porcine tissue valves have not been established for the following specific populations: patients with aneurysmal aortic degenerative conditions (e.G., cystic medial necrosis, marfan¿s syndrome)".

Event Description

On (b)(6) 2011, a 31mm epic valve was implanted on a patient with a comorbidity of marfan's syndrome.In 2014, a bentall procedure was performed.On (b)(6) 2020 a re-do double valve replacement(dvr) was performed due to calcification on both the epic valve and the prosthetic aortic valve(magna mitral ease by edwards lifesciences).The epic valve was replaced with a 31mm sjm masters series heart valve w/teflon cuff (serial#: (b)(6)) while the magna mitral ease valve was replaced with a 21mm sjm regent heart valve w/flex cuff (serial#: (b)(6)).Upon explant, pannus formation and a perforation were observed on the leaflets of the epic valve.Diagnosis on the epic valve before the dvr was moderate stenosis, which was thought to be caused by the pannus on the leaflets.As for the aortic valve (magna mitral ease), two of the leaflets have calcified and were fused.The patient was stable post procedure.

• 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
• MDR Report Key: 10181655
• MDR Text Key: 196224479
• Report Number: 3001883144-2020-00058
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: E100-31M
• Device Lot Number: 3367474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 45