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

Model Number A7700

Device Problems Calcified (1077); Material Separation (1562); Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); Calcium Deposits/Calcification (1758); No Information (3190)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.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 approximately sixteen years following the implant of this mechanical valve, this valve was explanted and replaced with a bioprosthetic valve.No failure mechanism and no adverse patient effects were reported.

Manufacturer Narrative

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.

Manufacturer Narrative

Medtronic received additional information that the surgeon had no complaint against the product, that it had simply "aged out" after sixteen years' duration.Patient's relevant medical history added.Unique device identifier added.

Manufacturer Narrative

Medtronic received additional information that this device was explanted and replaced due to severe aortic bioprosthesis regurgitation.Upon visualizing the valve in situ, the physician noted "an apparent partial dehiscence of the" valve, with "severe calcification of the annulus." no other adverse patient effects were reported.Patient and device codes updated.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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HALL EASY FIT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES 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: 6129662
• MDR Text Key: 60958174
• Report Number: 2025587-2016-01867
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 2025587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2005
• Device Model Number: A7700
• Device Catalogue Number: A7700E23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2000
• 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: 70 YR