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

Model Number 505

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Thrombus (2101); No Information (3190)

Event Date 03/07/2017

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.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 one day post implant of this mechanical valve, this valve was explanted and replaced.No failure mechanism and no other adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that postoperatively, the patient developed increasing pressor requirements and decreased urine output.Echocardiogram was performed in the patient's room and had poor visibility of valve, but it indicated a high gradient across the valve.The physician decided to re-operate.Upon visualizing the valve in situ, the physician noted significant thrombus around the valve; one leaflet was seized shut.The patient fared well post-replacement of this valve and no other adverse patient effects were reported.

Manufacturer Narrative

Correction: the following fields have been updated "date of event, implant date, explant date." 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: 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: 6517194
• MDR Text Key: 73539623
• Report Number: 3008592544-2017-00023
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00643169335028
• UDI-Public: 00643169335028
• 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,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2019
• Device Model Number: 505
• Device Catalogue Number: 505DA18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2016
• 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: 17 YR
• Patient Weight: 57