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

Model Number	500DM33
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Myocardial Infarction (1969); Pericardial Effusion (3271)
Date of Event	09/14/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 1 year 4 months post implant of this 33mm mitral mechanical valve, the patient passed away.The patients spouse called technical services inquiring about a recall for her husbands valve as she believed the death was related to a valve malfunction.The spouse stated that her husband had issues 1 week post implant, such as several strokes and seizures, along with a pericardial effusion and myocardial infarction (mi).The patients ejection fraction went from 66 down to 22 during this time and had issues with clotting.The patient saw several physicians, none of which could pinpoint any issue, however the last cardiologist the patient saw, stated that they thought the valve was "failing".It is unknown if an autopsy was performed.The valve was buried with the patient.

• Brand Name: OPEN PIVOT MECHANICAL HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 8015329
• Report Number: 3008592544-2018-00047
• Device Sequence Number: 1755189
• Product Code: LWQ
• UDI-Device Identifier: 00643169334915
• UDI-Public: 00643169334915
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2018

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: 05/26/2020
• Device Model Number: 500DM33
• Device Catalogue Number: 500DM33
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/29/2018
• 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: Death
• Patient Age: 74 YR