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

Model Number MDT-TISSUE VALVE

Device Problems Partial Blockage (1065); Calcified (1077); Entrapment of Device (1212); Gradient Increase (1270); Perivalvular Leak (1457); Reflux within Device (1522); Material Perforation (2205); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Calcium Deposits/Calcification (1758); Cardiac Arrest (1762); Endocarditis (1834); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Mitral Valve Stenosis (1965); Pulmonary Dysfunction (2019); Sepsis (2067); Multiple Organ Failure (3261); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Mitral Valve Insufficiency/ Regurgitation (4451); Bronchial Hemorrhage (4456); Gastrointestinal Hemorrhage (4476)

Event Date 05/04/2019

Event Type  Injury  

Event Description

Medtronic received information via literature comparing durability of mechanical, porcine, pericardial, and stented jugular vein valves used for surgical mitral valve replacement (mvr) in pediatric congenital heart disease patients.All data were collected from a single medical center between january 1992 and july 2018.The study population included 190 patients and multiple manufacturer¿s devices were implanted in the study population.Four patients were implanted with a medtronic hancock valved conduit; four were implanted with a medtronic mosaic bioprosthetic valve and 34 were implanted with a medtronic melody bioprosthetic valve (medtronic valve cohort was predominantly female, median age 3.2 years).No unique device identifier numbers were provided.Among all patients, 44 pediatric deaths occurred, with 15 of the deaths noted to be intra-operative.Causes of deaths included multiorgan failure, sepsis, cardiac arrest, congestive heart failure (chf), right/left ventricular failure, intracranial hemorrhage, pulmonary hemorrhage, gastrointestinal hemorrhage, pulmonary hypertension, endocarditis and other unknown causes.There was no direct statement of causal or contributory relationship between medtronic product and the deaths, however, the study did note varied risks of death based upon valve type implanted.Based on the available information medtronic product may have been associated with the deaths.Among all patients, adverse events included: need for multiple balloon dilatations to resolve high transvalvular gradients; need for re-do surgical mvr due to mitral stenosis/regurgitation, valve thromboses, leaflet entrapment and paravalvular leaks (pvl).Upon re-operation, all explanted porcine valves had significant pannus and calcification and most explanted melody valves had perforated leaflets.Based on the available information medtronic product was associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: choi p.; et al.Revisiting prosthesis choice in mitral valve replacement in children: durable alternatives to traditional bioprostheses.J thorac cardiovasc surg 2021 jan 01; 161(1):p213-225.E3.Doi: 10.1016/j.Jtcvs.2020.04.173.Available ahead of print may 31, 2020.Read at the 99th annual meeting of the american association for thoracic surgery, toronto, ontario, canada, may 4-7, 2019.Earliest date of publication used for date of event and date of death.Medtronic products referenced: hancock valved conduit (pma# p790007, product code: lwr); mosaic (pma# p990064, product code: dye); melody (pma# p140017, product code: npv).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.

• Brand Name: MEDTRONIC SURGICAL 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
• 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: 15468676
• MDR Text Key: 300419739
• Report Number: 2025587-2022-02614
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 3 YR
• Patient Sex: Female