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

Model Number MDT-TRANS VALVE

Device Problems Patient Device Interaction Problem (4001); Migration (4003); Central Regurgitation (4068)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Rupture (2208); Cardiac Tamponade (2226); Vascular Dissection (3160); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/20/2023

Event Type  Injury  

Manufacturer Narrative

Citation: bennes et al.Transfemoral versus trans-subclavian access in transcatheter aortic valve implantation using self-expandable valve: a propensity-matched comparison.Arch cardiovasc dis.2023 dec;116(12):555-562.Doi: 10.1016/j.Acvd.2023.09.006.Epub 2023 oct 20.Earliest date of publication used for date of event.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Literature was reviewed regarding transfemoral versus trans-subclavian access in transcatheter aortic valve implantation.The study population included 442 patients who were predominantly female with a mean age of 82.5 years.All patients were implanted with a medtronic corevalve (n=17), evolut r (n=294) or evolut pro (n=131) bioprosthetic valve.Deaths occurred in the study population; however, there was no statement establishing a causal or contributory relationship between medtronic product and the deaths.Among all patients adverse events included: st segment elevation myocardial infarct (stemi), stroke, annulus rupture, aortic dissection, valve migration, cardiac tamponade, acute kidney injury, major bleeding or vascular complication, arrhythmia requiring permanent pacemaker implant, moderate or severe aortic regurgitation, and conversion to open surgery.No further information was provided pertaining to medtronic products.

• 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: 19181015
• MDR Text Key: 341030626
• Report Number: 2025587-2024-02559
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/25/2024
• 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; Life Threatening
• Patient Age: 83 YR
• Patient Sex: Female