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

Model Number 505D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.If the product and/or additional information is received, a supplemental report will be submitted.

Event Description

Medtronic received information that approximately three years post implant of this mechanical valve, it was explanted and replaced due to increased gradients measuring 33 mmhg.The patient was symptomatic with dyspnea, chest pain, and fatigue.It was reported that upon explant the valve was functioning as intended and looked normal in appearance.No other adverse patient effects were reported.

Manufacturer Narrative

Correction: field "desc evt problem" has been updated.

Event Description

Medtronic received information that 3 years post implant of this mechanical valve, it was explanted and replaced due to increased gradients measuring 33 mmhg.The patient was symptomatic with dyspnea, chest pain, and fatigue.It was reported that upon explant the valve was functioning as intended and looked normal in appearance.It is believed that there is a patient prosthesis issue with the valve; therefore, the physician has elected to replace the device.No other adverse patient effects were reported.

Manufacturer Narrative

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

• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6016021
• MDR Text Key: 56913890
• Report Number: 3008592544-2016-00054
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990046
• 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
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2016
• Device Model Number: 505D
• Device Catalogue Number: 505DA22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2013
• 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: 56 YR
• Patient Weight: 102