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

Model Number E100-27M

Device Problems Obstruction of Flow (2423); Incomplete Coaptation (2507)

Patient Problems Corneal Pannus (1447); Heart Failure (2206)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On an unknown date in 2012 a 27mm epic stented porcine heart valve was implanted.Heart failure and transvalvular leakage occurred on the patient since a few years before.On (b)(6) 2020, the valve was explanted and the leaflet was found to have prolapsed and a pannus-like object adhered on the valve.A 23mm magna mitral ease valve was successfully implanted.The patient was reported to be in stable condition.

Manufacturer Narrative

Explant was reported due to heart failure and valve leakage.The investigation found that the sewing cuff had been disrupted in processing, which was associated with a tear in cusp 2.Cusp 3 was torn.There were degenerative changes to the tissue in cusp 3.Cusp 3 also contained calcifications.No acute inflammation was present.The cause of the tears could not be conclusively determined, however the degenerative changes to the tissue could have contributed to the tear formation.

Manufacturer Narrative

Explant was reported due to heart failure and valve leakage.The investigation found that the sewing cuff had been disrupted in processing, which was associated with a tear in cusp 2.Cusp 3 was torn.There were degenerative changes to the tissue in cusp 3.Cusp 3 also contained calcifications.No acute inflammation was present.The degenerative changes to the tissue could have contributed to the tear formation.In addition, the pannus formation noted on the valve and the selected valve size (23 mm) larger than the replacement valve (27 mm),is possible evidence of oversizing.This had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, which could lead to leaflet tears and reduced durability.

• 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.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 10527914
• MDR Text Key: 206751527
• Report Number: 3001883144-2020-00087
• 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,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E100-27M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR