MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT STANDARD AORTIC HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500FA

Device Problem Incomplete Coaptation (2507)

Patient Problem Foreign Body Reaction (1868)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Citation: asil et al.Stuck leaflets in prosthetic heart valves with different etiology and treatments.E j cardiovasc med 2022;10(4 ):153-159.Doi: 10.32596/ejcm.Galenos.2022.2022-09-046.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 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 a 65-year-old female patient who three years prior had been implanted with a medtronic open pivot mechanical valve in the mitral position. the patient recently presented with shortness of breath.  transthoracic echocardiography (tte) showed an increased transvalvular gradient of 29 mmhg.  transesophageal echocardiogram (tee) and fluoroscopy revealed restricted valve leaflet movement. in surgery, the atrial surface of the mitral prosthesis was noted with tissue overgrowth which was limiting the movement of the posterior valve leaflet. the mechanical prosthetic valve was then explanted and successfully replaced with a medtronic hancock ii bioprosthetic valve.  no additional adverse patient effects or product performance issues were reported.

• Brand Name: OPEN PIVOT STANDARD AORTIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16432837
• MDR Text Key: 310130512
• Report Number: 3008592544-2023-00019
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500FA
• Device Catalogue Number: 500FA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Female