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

Model Number A7700E22

Device Problem Insufficient Information (3190)

Patient Problem Host-Tissue Reaction (1297)

Event Date 07/01/2019

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 approximately 20 years and 8 months post implant of this 22mm aortic mechanical valve, it was explanted and replaced with an unknown device.The reason for replacement was reported as pannus around the valve.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: 8827705
• MDR Text Key: 152237190
• Report Number: 2025587-2019-02339
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A7700E22
• Device Catalogue Number: A7700E22
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2019
• 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: 66 YR