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 Problem Obstruction of Flow (2423)

Patient Problem Mitral Valve Stenosis (1965)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The article "prospective evaluation of transseptal tmvr for failed surgical bioprostheses: mitral trial valve-in-valve arm 1-year" was reviewed.This research article is a prospective multi center experience to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (mviv) with the sapien 3 aortic transcatheter heart valve (thv) in the mitral (mitral implantation of transcatheter valves) trial.It was reported that between july 2016 and october 2017, 30 patients underwent mitral valve in valve procedure.Patient comorbidities included: diabetes, atrial fibrillation, chronic kidney disease, chronic obstructive pulmonary disease, heart failure, stroke, coronary artery bypass(cabg).One patient was an (b)(6) year old female previously implanted with a 31mm epic valve.The patient underwent a mitral valve in valve procedure due to mitral stenosis and was implanted with a 29mm sapien 3 valve.The article concluded that transseptal mitral valve in valve(mviv) in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year.The primary and correspondence author of the article is mayra guerrero, md, mayo clinic college of medicine, department of cardiovascular medicine, mayo clinic hospital, 1216 2nd street sw, rochester, minnesota 55905, usa with the corresponding email mayraguerrero@icloud.Com.

Manufacturer Narrative

As reported in a research article, a patient required valve in valve intervention due to stenosis.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
• MDR Report Key: 11939693
• MDR Text Key: 254298716
• Report Number: 3001883144-2021-00080
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: E100-31M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR