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 E100-27M

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Aortic Regurgitation (1716); Mitral Regurgitation (1964)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2014, a 27mm epic valve was implanted with everting mattress suture technique using pledgets in the patient's mitral position in another hospital due to rheumatic mitral insufficiency.Early 2020, the patient was re-hospitalized due to mitral regurgitation and aortic regurgitation.A double valve replacement (dvr) was performed on (b)(6) 2020.The epic valve was explanted and replaced with a 25mm ats open pivot bileaflet heart valve.Upon explant, a tear was observed along the commissure between leaflets.No infection or pannus in growth was observed on the explanted valve.

Manufacturer Narrative

Additional information for: d10, g4, g7, h2, h3, h6, and h10.The tear seen at explant was confirmed.Cusp 2 was torn.There was fibrous pannus ingrowth on the inflow surface of cusps 2 and 3.A microcalcification was present at the base of cusp 1.All three cusps had degenerative changes to the tissue.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 cause of the tear could not be conclusively determined; however, the degenerative changes to the tissue could have contributed to the tear formation, and the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading 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. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 9903133
• MDR Text Key: 187626603
• Report Number: 3001883144-2020-00029
• 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
• Report Date: 04/20/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2018
• Device Model Number: E100-27M
• Device Lot Number: 4652026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 04/15/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR