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

Model Number MDT-ANNULOPLASTY

Device Problems Degraded (1153); Gradient Increase (1270); Perivalvular Leak (1457)

Patient Problems Arrhythmia (1721); Dyspnea (1816); Endocarditis (1834); Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 06/22/2022

Event Type  Injury  

Event Description

Medtronic received information from a literature article regarding transcatheter mitral valve replacement (tmvr) in high-surgical risk patients.All data was retrospectively collected from a single center between february 2017 and september 2020.The study population included 64 patients (predominantly female; mean age 62.7 years; mean weight 61.7 kg) who underwent tmvr using edwards sapien-3 valves.Of these 64 patients, 9 had a previously implanted medtronic surgical mitral valve (hancock ii = 2, mosaic = 7) and 4 had a previously implanted medtronic mitral annuloplasty ring (brand names not disclosed).No unique device identifier numbers were provided.Among all 64 patients in the study, the authors observed the following clinical symptoms and device failure modes prior to tmvr: palpitation, dyspnea, chest pain, stroke, heart failure, degeneration, endocarditis, atrial fibrillation (associated with valvular degeneration), mitral stenosis, valvular or paravalvular mitral regurgitation (mild to severe), and elevated gradients.At the time of tmvr, the mean implant durations for the surgical valve and annuloplasty ring patients were 9.9 years and 8.6 years, respectively.All medtronic surgical valve patients underwent transcatheter mitral valve-in-valve replacement.All medtronic annuloplasty ring patients underwent transcatheter mitral valve-in-ring replacement.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: taha fa, et al.Transcatheter mitral valve replacement in high-surgical risk patients: a single-center experience and outcome.Journal of interventional cardiology.2022 jun 22;2022:6587036.Doi: 10.1155/2022/6587036.Earliest date of publish used for date of event.Medtronic products referenced: ¿medtronic rings¿.Earliest approved medtronic annuloplasty 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 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: 15329970
• MDR Text Key: 299008794
• Report Number: 2025587-2022-02424
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K052860
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• 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
• Date Manufacturer Received: 08/05/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 62 KG