MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS; RING, ANNULOPLASTY

Model Number MDT-ANNULOPLASTY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Chest Pain (1776); Dyspnea (1816); Hemorrhage/Bleeding (1888); Hemothorax (1896); Unspecified Infection (1930); Pleural Effusion (2010); Pneumothorax (2012); Transient Ischemic Attack (2109); Pseudoaneurysm (2605); Thromboembolism (2654); Pericardial Effusion (3271)

Event Date 08/13/2022

Event Type  Injury  

Manufacturer Narrative

Citation: mazur pk, et al.Apixaban for anticoagulation after robotic mitral valve repair.The annals of thoracic surgery.2023 apr; 115(4):966-973.Doi: 10.1016/j.Athoracsur.2022.07.045.Epub 2022 aug 13.Earliest date of publication used for date of event.Medtronic product referenced: ¿63-mm flexible partial annuloplasty band (medtronic, fridley, mn).¿ used earliest approved medtronic annuloplasty band (cg future) 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 the outcomes of post-mitral valve repair anticoagulation with apixaban compared to warfarin.A total of 626 patients were included in the study population.In all cases, a non-medtronic robotic surgery system (intuitive surgical, inc.) was used and annuloplasty was performed using a 63 mm medtronic flexible partial annuloplasty band.The authors observed four deaths after a median follow-up of three years.No evidence was presented to suggest that a medtronic device or its function contributed to any of the deaths.Other adverse events that occurred were described as follows: stroke (ischemic in nature), re-exploration for surgical bleeding, reoperation for valve dysfunction, prolonged mechanical ventilation, pneumothorax, wound infection, post-operative atrial fibrillation, acute kidney injury, transient ischemic attack, and hospital readmission within 30 days post-procedure.Reasons for hospitalization included: gastrointestinal bleeding, hemothorax secondary to right internal mammary artery pseudoaneurysm managed by tube thoracostomy and coil embolization, venous thromboembolism, atrial fibrillation, pleural effusion, pericarditis, chest pain or dyspnea, pericardial effusion/pericardiocentesis, infectious complication, and other reasons.No additional adverse patient effects were noted.

• Brand Name: MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
• Type of Device: RING, ANNULOPLASTY
• 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: 16850124
• MDR Text Key: 314360024
• Report Number: 2025587-2023-01885
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052860
• 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: 05/01/2023

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-ANNULOPLASTY
• Device Catalogue Number: MDT-ANNULOPLASTY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 05/01/2023
• 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; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male