MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION HALL EASY FIT; HEART-VALVE, MECHANICAL

Model Number A7700E25

Device Problem Insufficient Information (3190)

Patient Problem Aortic Regurgitation (1716)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 16 years and 5 months post implant of this mechanical aortic valve, it was explanted and replaced with a non-medtronic mechanical valve.The reason for replacement was a "leaky" valve.No additional adverse patient effects were reported.Additional information was received that the valve was replaced due to it being "leaky" (regurgitation).No additional adverse patient effects were reported.

• Brand Name: HALL EASY FIT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8663745
• MDR Text Key: 146831031
• Report Number: 2025587-2019-01774
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A7700E25
• Device Catalogue Number: A7700E25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2019
• 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
• Patient Age: 65 YR
• Patient Weight: 73