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

Device Problems Backflow (1064); Obstruction of Flow (2423)

Patient Problems Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 06/11/2021

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a tissue valve was replaced due to regurgitation and/or 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.

Event Description

The article, " effects of transapical transcatheter mitral valve implantation", was reviewed.This research article is a retrospective single center experience to compare transapical transcatheter mitral valve-in-valve implantation (tamvi) with surgical redo mitral valve replacement (srmvr) in terms of clinical outcomes.Edwards sapien, st.Jude medical tissue valve, on-x, medtronic hancock, sorin bicarbon, c-e perimount magna mitral ease and mosaic tissue valves were associated with the study.The article concluded that the statistical analysis is still not robust enough to make a claim that tamvi is an appropriate alternative.The outcome of the patient appears only to be related to the patient¿s pre-operative sts score.The primary author of the article is ming-chon hsiung, heart center, cheng hsin general hospital, taipei, taiwan.The correspondence author of the article is jeng wei, heart center, cheng hsin general hospital, taipei, taiwan with the corresponding email: jengwei@mac.Com.

• Brand Name: SJM TISSUE HEART 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: 12249504
• MDR Text Key: 264273126
• Report Number: 3001883144-2021-00111
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2021
• 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): Required Intervention
• Patient Age: 62 YR