MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC TRANSCATHETER VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number MDT-TRANS VALVE

Device Problems Partial Blockage (1065); Calcified (1077); Degraded (1153); Perivalvular Leak (1457); Reflux within Device (1522); Device Appears to Trigger Rejection (1524); Inadequacy of Device Shape and/or Size (1583); Structural Problem (2506); Malposition of Device (2616); Material Split, Cut or Torn (4008)

Patient Problems Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Endocarditis (1834); Foreign Body Reaction (1868); Obstruction/Occlusion (2422); Cusp Tear (2656); Vascular Dissection (3160); Thrombosis/Thrombus (4440); Cardiovascular Insufficiency (4445); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

Citation: jun j.; et al.Cardiac operations after transcatheter aortic valve replacement.Ann thorac surg.2022 jul;114(1):52-59.Doi: 10.1016/j.Athoracsur.2021.10.022.Pmid: (b)(4).Epub 2021 nov 17.Earliest date of publication used for date of event.Medtronic products referenced: corevalve, evolut r, evolut pro (pma# p130021, product code: npt).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 outcomes in patients who required cardiac surgery after a prior transcatheter aortic valve replacement (tavr).All data were collected from a single u.S.Medical center between january 2012 and july 2020.The study population included 59 patients who were predominantly male with a mean age of 70 years.Multiple manufacturer¿s devices were implanted in the study population.Among all patients 29 were implanted with a medtronic corevalve, evolut r or evolut pro bioprosthetic valve (unique device identifier numbers not provided).Among all patients, eight deaths occurred, with five cases of operative mortality and three cases of in-hospital post-surgical mortality.None of the deaths involved patients with medtronic tavr valves.Based on the available information medtronic product was not associated with the deaths.Among all patients, adverse events included: structural valve deterioration including calcification, fibrosis/neo-endothelialization, valve leaflet tears and stent disposition issues.Non-structural issues involved device malposition, pannus formations, patient-prosthesis mismatches, and coronary artery obstruction.Patients experienced severe bioprosthetic aortic stenosis/regurgitation, severe paravalvular leaks (pvls), aortic dissections, infective endocarditis and valve thromboses.Patients required hospitalization and surgery for tavr explantation, followed by surgical aortic valve replacement (savr)and/or aortic root replacement.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 TRANSCATHETER VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• 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: 15202515
• MDR Text Key: 297678153
• Report Number: 2025587-2022-02203
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• 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: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-TRANS VALVE
• Device Catalogue Number: MDT-TRANS VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White