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

Model Number MDT-TISSUE VALVE

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Heart Block (4444); Respiratory Insufficiency (4462)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

Citation: elbadawi a, saad m, elgendy iy, et al.Temporal trends and outcomes of transcatheter versus surgical aortic valve replacement for bicuspid aortic valve stenosis.Jacc cardiovasc interv.2019;12(18):1811-1822.Doi:10.1016/j.Jcin.2019.06.037 earliest date of publication used for date of event.Medtronic surgical valve products that may been involved in the study: 3f (product code lwr, pma# p060025), freestyle (product code lwr, pma# p970031), hancock ii (product code dye, pma# p980043), mosaic (product code dye, pma# p990064).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.

Event Description

Literature was reviewed regarding a comparison of transcatheter (tavr) and surgical aortic valve replacement (savr) for bicuspid aortic stenosis (as).The authors extracted de-identified data from an inpatient database to identify and analyze hospitalizations for bicuspid as who underwent isolated aortic valve replacement between the years 2012 and 2016.As the study data was de-identified, no product information (manufacturer, brand name, model and/or serial number) was documented in the article pertaining to the transcatheter and surgical aortic valves implanted in the patient population.However, it is likely that transcatheter and surgical valve products manufactured by medtronic were among the valve types used.The in-hospital mortality rates were 3.1% (tavr group) and 3.1% (savr group) in the tavr versus savr matched cohort, whereas in the tavr in bicuspid as versus tavr in tricuspid as matched cohort, the in-hospital mortality rates were 2.9% (tavr in bicuspid as group) and 3.4% (tavr in tricuspid as group).No evidence was presented to suggest that a medtronic valve or its function contributed to any of the deaths.Other comparative outcomes were described as follows: cardiac arrest, cardiogenic shock, mechanical circulatory support, acute kidney injury, acute myocardial infarction, c ardiac tamponade, respiratory complications, post-operative bleeding, blood transfusions, acute stroke, ventricular arrhythmias, complete heart block, permanent pacemaker implantation, and vascular complications.No additional adverse effects were noted.

• 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: 17499606
• MDR Text Key: 320815570
• Report Number: 2025587-2023-03302
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• 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
• Date Manufacturer Received: 07/20/2023
• 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; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White