MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. EPIC STENTED TISSUE VALVE (UNKNOWN); HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Backflow (1064)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Mitral Valve Stenosis (1965); Heart Block (4444); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Type  Injury  

Event Description

Related manufacturer reference number: 3001883144-2022-00006.The article, "modes of the bioprosthetic valve failure of the porcine and pericardial valves in the mitral position", was reviewed.This article is a retrospective single study experience to examine the incidence and modes of the bioprosthetic valve failure of the porcine valve in the mitral position and compare them with those of the pericardial valve.St jude epic bioprosthesis and carpentier edwards perimount pericardial valve were associated with this study.The article concluded that the rate of reoperation for svd was slightly higher for the porcine valve in the mitral position than for the pericardial valve.Moreover, porcine valve failure due to leaflet tearing exhibited rapid worsening.[the primary author of this article : gaku uchino, md, department of cardiovascular surgery, hyogo brain and heart center, 520 saisho, himeji, hyogo 670-0981, japan, the corresponding author is hirohisa murakami, md, department of cardiovascular surgery, hyogo brain and heart center, with email address : nrd15919@nifty.Com].

Manufacturer Narrative

As reported in a research article, patients implanted with pericardial tissue valves had complications of bleeding, left ventricular rupture, atrioventricular block, stroke, new hemodialysis, prolonged ventilation, structural valve deterioration, mitral regurgitation, mitral stenosis, leaflet tears, pannus formation and reoperation caused by structural valve deterioration.In the patients implanted with epic valves, endocarditis and thrombosis was observed.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 TISSUE VALVE (UNKNOWN)
• 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: 13256903
• MDR Text Key: 289060469
• Report Number: 3001883144-2022-00005
• 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: 01/14/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/14/2022
• 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: 76 YR
• Patient Sex: Female