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

Model Number MDT-TRANS VALVE

Device Problems Degraded (1153); Difficult or Delayed Positioning (1157); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Endocarditis (1834); Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)

Event Date 05/31/2023

Event Type  Death  

Event Description

Literature was reviewed regarding bioprosthetic value dysfunction (bvd) following transcatheter aortic valve implantation (tavi).The study population included 622 patients who were predominantly female with a mean age of 82 years.  multiple manufacturer¿s devices were implanted in the study population; 90 patients were implanted with a medtronic corevalve, evolut r or evolut pro bioprosthetic transcatheter valve.Of the 622 patients there were 228 all-cause deaths at 44 months post-tavi.  the authors concluded bvd was independently associated with all-cause death.  the deaths associated specifically with medtronic valves was not disclosed.  among all patients adverse events included: bvd defined as structural valve deterioration, residual intra- or peri-prosthetic aortic regurgitation, inappropriate positioning or sizing, patient-prosthesis mismatch, leaflet thrombosis, or endocarditis; major vascular or bleeding complication; stroke with disability; arrhythmia requiring permanent pacemaker implant; renal failure; valve migration.  no further information pertaining to medtronic products was noted.

Manufacturer Narrative

Citation: nitsche et al.Incidence, causes, correlates, and outcome of bioprosthetic valve dysfunction and failure following transcatheter aortic valve implantation.Eur heart j cardiovasc imaging.2023 may 31;24(6):796-806.Doi: 10.1093/ehjci/jeac188.Earliest date of publication used for date of event and date of death.Medtronic products referenced: corevalve, evolut r, evolut pro.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: 17865905
• MDR Text Key: 324864642
• Report Number: 2025587-2023-03995
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• 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: 09/25/2023
• 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): Death
• Patient Age: 82 YR
• Patient Sex: Female