MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT STANDARD AORTIC HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500FA

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Myocardial Infarction (1969)

Event Date 10/27/2021

Event Type  Injury  

Event Description

Medtronic received information from a literature article regarding a cost comparison between transcatheter aortic valve implantation (tavi) and surgical aortic valve replacement (savr).All data was retrospectively collected from a single center between january 2019 and february 2020.A total of 238 patients were included in the study population.Of these, 141 underwent tavi (predominantly female, median age 84 years) and 97 underwent savr (predominantly male, median age 75 years).In the tavi group, 106 patients were treated with a medtronic evolut r valve system.In the savr group, an unspecified number of patients were implanted with a medtronic ats mechanical valve.No unique device identifier numbers were provided.Among all 238 patients, 8 in-hospital deaths occurred.Non-medtronic devices were also used in the study.No statement was made suggesting a causal or contributory relationship between medtronic product and the deaths.Evolut r transcatheter valves may have been associated with the following adverse events: cerebrovascular accident/stroke (ischemic, hemorrhagic, or disabling); bleeding (life-threatening, disabling, or major); need for red blood cell transfusion; atrioventricular block; left bundle branch block; new onset atrial fibrillation; need for permanent pacemaker implantation; need for a second valve; and need for hospital admission during follow-up.Enveo r delivery catheter systems may have been associated with the following adverse events: unspecified major/minor vascular access-related complications.No interventions were reported to have been performed for these complications.Ats mechanical valves may have been associated with the following adverse events: myocardial infarction; cerebrovascular accident/stroke (ischemic or disabling); bleeding (life-threatening, disabling, or major); need for red blood cell transfusion; atrioventricular block; left bundle branch block; new onset atrial fibrillation; need for permanent pacemaker implantation; repeat surgery for sternal dehiscence or mediastinitis; and need for hospital admission during follow-up.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: areces s, et al.Cost comparison between transcatheter aortic valve implantation and surgical valve replacement using individual data in a spanish public hospital.Cirugía cardiovascular.2021 nov-dec; 28(6): 317-324.Doi: 10.1016 / j.Circv.2021.07.006.Available online 27 october 2021.Earliest date of publish used for date of event.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: OPEN PIVOT STANDARD AORTIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14364104
• MDR Text Key: 294673038
• Report Number: 3008592544-2022-00020
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P990046
• 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: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500FA
• Device Catalogue Number: 500FA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• 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): Life Threatening; Disability; Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male