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

Model Number MDT-TRANS VALVE

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Incomplete Coaptation (2507)

Patient Problems Angina (1710); Stroke/CVA (1770); Dyspnea (1816); Transient Ischemic Attack (2109); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/06/2022

Event Type  Injury  

Event Description

Medtronic received information from a literature article regarding the long-term risk of early hypoattenuated leaflet thickening (halt) after transcatheter aortic valve replacement (tavr).All data was collected from a single center between may 2012 and december 2017.Overall, 804 patients were included in the study population (predominantly female, mean age 82.1 years).Patients underwent tavr with either a non-medtronic valve type (n = 675) or a medtronic evolut r or pro valve (n = 129).No unique device identifier numbers were provided.After tavr, 115 patients developed halt and the remaining 689 did not.Among all 804 patients, 292 deaths occurred during the median follow-up of 3.25 years, including 250 patients without halt and 42 patients with halt.No statement was made suggesting a causal or contributory relationship between medtronic product and the deaths.Among all 804 patients, non-death adverse events included: stroke; transient ischemic attack; mild to moderate paravalvular leak; symptomatic hemodynamic valve deterioration (defined as a 10 mm hg increase in the mean gradient or a mean gradient =20 mm hg with new onset or aggravation of dyspnea, or new onset of angina); halt with reduced leaflet motion; and bioprosthetic valve failure (defined as aortic valve reintervention and/or a 20 mm hg increase in the mean gradient, a mean gradient =40 mm hg, or severe intra-prosthetic aortic regurgitation).In 10 cases, halt regression was observed via computed tomography angiography and/or decreasing gradients on transthoracic echocardiography after the addition or change of anticoagulation therapy.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: hein m, et al.Long-term follow-up of hypoattenuated leaflet thickening after transcatheter aortic valve replacement.Jacc: cardiovascular interventions.2022 jun 13;15(11):1113-1122.Doi: 10.1016/j.Jcin.2022.04.018.Available online (b)(6) 2022.Earliest date of publish used for date of event.Medtronic products referenced: evolut r (pma# p130021, product code npt), 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.

• 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: 15117460
• MDR Text Key: 296749107
• Report Number: 2025587-2022-02113
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130021
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 07/20/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female