MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC FLEX; HEART-VALVE, MECHANICAL

Model Number 500FA25

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Pericardial Effusion (3271)

Event Date 05/21/2023

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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 that 9 days post implant of this 25mm aortic mechanical valve, it was reported that an echocardiogram (echo) discovered a large, liquid, circular pericardial effusion with partial swinging heart.It was also reported that the patient had symptoms of being spastic, cyanotic, cold and sweaty.Oxygen was administered and re-intubation was performed and was transferred to the intensive care unit (icu).The patient was resuscitated due to cardiac arrest for 5-7 minutes.Intervention occurred as emergency surgery to unload 600ml of venous old blood.It was also reported that medication was given.No additional adverse patient effects were reported.

• Brand Name: AORTIC FLEX
• 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: 17190851
• MDR Text Key: 317743833
• Report Number: 3008592544-2023-00067
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500FA25
• Device Catalogue Number: 500FA25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2023
• Date Device Manufactured: 01/19/2023
• 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
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 88 KG