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

Model Number MDT-ANNULOPLASTY

Device Problem Degraded (1153)

Patient Problems Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

Citation: simonato m.; et al.Transcatheter mitral valve replacement after surgical repair or replacement: comprehensive mid-term evaluation of valve-in-valve and valve-in-ring implantation from the vivid registry.Circulation, 2021 jan 12;143(2):104-116.Doi: 10.1161/circulationaha.120.049088.Pmid: 32975133.Epub 2020 sep 25 earliest date of publication used for date of event.Medtronic products referenced: duran ancore band (pma# k960356, product code: krh); cg future band (# k052860, krh); profile 3d ring (# k073324, krh); hancock surgical tissue valve (# p870078, dye); mosaic surgical tissue valve (# p990064, dye).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

Medtronic received information via literature regarding the survival benefit of valve-in-valve (viv)/valve-in-ring (vir) mitral valve replacement in patients with recurrent mitral valve failures.All data were collected from an international clinical registry for cases performed between march 2006 and march 2020.The study population included 1079 patients who were predominantly female with amean age of 74 years and mean weight of 70 kg.Among all patients who required vir mitral valve replacement, 13.3% were previously implanted with medtronic mitral rings/bands including duran ancore, cg future and profile 3d models (unique device identifier numbers not provided).Among all patients who required viv mitral valve replacement, 30.1% were previously implanted with medtronic surgical tissue bioprosthetic valves including hancock and mosaic models (unique device identifier numbers not provided).The majority of transcatheter mitral valve replacements (tmvr) were conducted using a non-medtronic manufacturer¿s product, however other manufacturers and models were not described.Among all patients, adverse events included: mild-severe mitral regurgitation and mitral stenosis related to ring/valve structural f ailure.Based on the available information medtronic product was directly associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• 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: 14538441
• MDR Text Key: 293849617
• Report Number: 2025587-2022-01505
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 05/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN IPG
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 70 KG