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

Model Number	505
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/30/2017
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.Additional information has been requested, but no new information has been received to date.
Event or Problem Description
Medtronic received information that 1 year 9 months post implant of this aortic mechanical valve, the device was explanted and replaced with a mechanical valve for unknown reasons.No further adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information received indicated that the patient presented with a recurrent pseudoaneurysm of the aortic graft.The physician noted that the pseudoaneurysm was easily visualized after a clot was removed and could be seen bleeding from a previous pericardial patch.The physician dissected around the native aorta just below the takeoff of the right common carotid artery and left common carotid artery.The physician explanted the previous aortic graft along with this mechanical valve.The physician implanted a 23 mm mechanical valved conduit.The post operative mean gradient was 6mmhg.No further adverse patient effects were reported.
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: 6354496
• Report Number: 3008592544-2017-00006
• Device Sequence Number: 19132805
• Product Code: LWQ
• UDI-Device Identifier: 00643169335011
• UDI-Public: 00643169335011
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2017

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: 09/10/2016
• Device Model Number: 505
• Device Catalogue Number: 505DA20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: Not provided; 02/23/2017
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 03/02/2017; 09/29/2017
• 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: 41 YR