MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number MDT-TISSUE VALVE

Device Problem Perivalvular Leak (1457)

Patient Problems Adult Respiratory Distress Syndrome (1696); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Valvular Insufficiency/ Regurgitation (4449)

Event Date 03/01/2018

Event Type  Injury  

Event Description

Medtronic received information from a literature article regarding a propensity-matched comparison of right anterior mini-thoracotomy versus conventional sternotomy for aortic valve replacement.Between january 2010 and may 2016, 1,180 patients underwent minimally invasive or conventional aortic valve replacement at two centers.Patients were implanted with either a non-medtronic valve brand (n = 1,050) or a medtronic surgical valve brand (freestyle = 2, mosaic = 112).No unique device identifier numbers were provided.After propensity matching, 726 patients (363 patients per surgical approach) were included in the study population (predominantly male, mean age 73.1 years).Among all 726 patients, approximately 14 in-hospital deaths occurred.No statement was made suggesting a causal or contributory relationship between medtronic product and the deaths.Among all 726 patients, in-hospital adverse events included: conversion to full sternotomy due to paravalvular leak; re-exploration for bleeding; major stroke; dialysis; infections (local or systemic); permanent pacemaker implantation; acute respiratory distress syndrome; post-surgical delirium; and red blood cell transfusions.Besides the in-hospital adverse events, one patient required reoperation due to early endocarditis.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: del giglio m, et al.Right anterior mini-thoracotomy vs.Conventional sternotomy for aortic valve replacement: a propensit y-matched comparison.Journal of thoracic disease.2018 mar;10(3):1588-1595.Doi: 10.21037/jtd.2018.03.47.Earliest date of publication used for date of event: march 01, 2018 (month and year valid).Fda approved medtronic products referenced: freestyle (pma# p970031, product code lwr), mosaic (pma# p990064, product code dye).Earliest approved product used for product code and pma#.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product, no definitive conclusion can be made regarding the clinical observations.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC SURGICAL TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15709968
• MDR Text Key: 302794013
• Report Number: 2025587-2022-03037
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/01/2022
• 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; Hospitalization; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male