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

Model Number 40017

Device Problem Perivalvular Leak (1457)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Myocardial Infarction (1969); Pneumonia (2011); Renal Failure (2041); Heart Block (4444); Valvular Insufficiency/ Regurgitation (4449)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Citation: herry m et al.Pacemaker implantation after aortic valve replacement: rapid-deployment intuity compared to conventional bioprostheses.European journal of cardio-thoracic surgery.2020; 58:335-342.Doi: 10.1093/ejcts/ezaa068 earliest date of publish used for event date.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a comparison of the incidence of permanent pacemaker implants following aortic valve replacement using either a rapid-deployment bioprosthesis or a standard bioprosthesis.All data were collected from a single center between january 2015 and september 2018.The study population included 924 patients (predominantly male, mean age 73.2 years), an unspecified number of whom were implanted with a medtronic avalus bioprosthetic valve (no serial numbers provided).Among all patients, 33 in-hospital deaths occurred.It was reported that 9 of these patients received a rapid-deployment bioprosthesis and 24 received a standard bioprosthesis.No association was made between the deaths and a specific manufacturer¿s product.Based on the available information medtronic product was not directly associated with the deaths.Among all patients, adverse events included: permanent pacemaker or implantable cardioverter defibrillator implant due to right bundle branch block (rbbb), left bundle branch block (lbbb), first-degree heart block, second-degree heart block, left hemiblock, complete heart block, sinus dysfunction, atrial fibrillation; major bleeding requiring transfusion; more than mild paravalvular regurgitation; deep wound sternal infections; acute renal failure requiring dialysis; reintubation; stroke/cerebral ischemic events; pneumonia; myocardial infarction.Based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Medtronic received additional information from the physician/author that medtronic product did not cause or contribute to any of the deaths or adverse events reported in the literature.No additional adverse patient effects were reported.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: AVALUS AORTIC 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
• MDR Report Key: 11335833
• MDR Text Key: 232319992
• Report Number: 2025587-2021-00569
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P170006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 40017
• Device Catalogue Number: 40017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR