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

Model Number	505
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Thrombus (2101); No Information (3190)
Date of Event	03/07/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
Additional 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: AORTIC AP
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 6517194
• Report Number: 3008592544-2017-00023
• Device Sequence Number: 11063210
• Product Code: LWQ
• UDI-Device Identifier: 00643169335028
• UDI-Public: 00643169335028
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2019
• Device Model Number: 505
• Device Catalogue Number: 505DA18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 05/24/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 05/09/2017; 05/24/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Weight: 57