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

Model Number A7700-22

Device Problems Gradient Increase (1270); Structural Problem (2506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen was not returned for evaluation.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.

Event Description

Medtronic received information from this patient's physician that following implant of this bioprosthetic valve (implant duration un known), this patient presented with elevated gradients, elevated flow rates, and a valve angle opening of 60 degrees.This physician declined to offer patient name and valve serial number, or specifics regarding the patient's symptoms.The valve was subsequently replaced by a different physician.No other adverse patient effects were reported.

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: 5588650
• MDR Text Key: 43151197
• Report Number: 2025587-2016-00568
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A7700-22
• Device Catalogue Number: A7700-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: No
• 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