MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number	500
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	05/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been received for analysis.Without the return of the product, a definitive conclusion cannot 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 year and two months post implant of this mechanical valve, it was explanted and replaced due to thrombosis of one of the leaflets in the closed position.It was reported that the patient discontinued anticoagulant therapy for approximately one month, which was identified as the reason for the clotting.No other adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: OPEN PIVOT MECHANICAL HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 6635996
• Report Number: 3008592544-2017-00034
• Device Sequence Number: 16296917
• Product Code: LWQ
• UDI-Device Identifier: 00643169335066
• UDI-Public: 00643169335066
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2017

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: 11/06/2019
• Device Model Number: 500
• Device Catalogue Number: 500DM29
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 09/07/2017
• 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