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

Model Number 501DA22

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 03/25/2024

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.Conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure (open or catheter-based) and can be resolved with medical treatment or the implant of a permanent pacemaker (with the risk-benefit ratio in favor of implant of the percutaneous aortic valve).A conduction disturbance does not indicate a device malfunction or potential manufacturing issue.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

Medtronic received information that 12 days post implant of this 22mm aortic mechanical valve, a permanent pacemaker was implanted.The reason for the permanent pacemaker was reported as recurrent sinus node arrest with hemodynamic instability.No additional adverse patient effects were reported.

• Brand Name: AORTIC AP
• 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: 19086256
• MDR Text Key: 339883930
• Report Number: 3008592544-2024-00025
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 501DA22
• Device Catalogue Number: 501DA22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 68 KG