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

Model Number E100-31M

Device Problems Off-Label Use (1494); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Tricuspid Valve Stenosis (2113); Heart Failure/Congestive Heart Failure (4446)

Event Type  Injury  

Event Description

The article, "a case of re-replacement of bioprosthetic tricuspid valve stenosis due to pannus and remnants of native tricuspid valve leaflets", was reviewed.This research article reported a case study of a (b)(6) year old male who received chemoradiotherapy for malignant lymphoma in the middle lung field at the age of (b)(6).At the age of (b)(6) and (b)(6), the patient underwent two bypass surgeries for radiation induced coronary artery disease.At the age of (b)(6), the patient developed right heart failure due to severe tricuspid regurgitation and underwent bioprosthetic tricuspid valve replacement (tvr) with a 31mm epic valve.After the operation, the mean pressure gradient of the artificial valve gradually increased and the patient was hospitalized for right sided heart failure again at the age of (b)(6).Redo bioprosthetic tvr with a 31mm cep mitral plus was performed for catecholamine dependent right heart failure due to tricuspid valve stenosis.Intraoperative findings included no degeneration of the bioprosthetic tricuspid valve, a decrease in valve area of bioprosthetic valve by marked growth of pannus on the right atrial side, and restricted mobility in leaflets of the bioprosthetic valve due to adhesion of remnants from the native tricuspid valve leaflets on the right ventricular side.[the primary and corresponding author is kousei matsuda md, cardiovascular medicine, sendai medical center, 8-8, miyagino 2-chome, miyagino-ku, sendai, miyagi, japan.].

Manufacturer Narrative

In a research article right heart failure, stenosis, pannus formation and restricted leaflet mobility were reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13101651
• MDR Text Key: 288288594
• Report Number: 3001883144-2021-00153
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: E100-31M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 52 YR
• Patient Sex: Male