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

Model Number	500DM27
Medical Device Problem Codes	Incomplete Coaptation (2507); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Corneal Pannus (1447); Mitral Insufficiency (1963); Mitral Valve Stenosis (1965); Stenosis (2263)
Date of Event	07/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 4 years 9 months post implant of this 27 mm mitral mechanical valve, it was explanted and replaced.An echocardiogram showed that the anterior leaflet appeared to be fixed, which caused mitral insufficiency and stenosis at the periphery of the valve.The valve was explanted and successfully replaced with a bioprosthetic valve.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed damage to the sewing ring and both leaflets were in the closed position, intact and no evidence of damage such as cracks and/or surface anomalies.Both the inflow and outflow valve hinge mechanisms and orifices were intact with no evidence of damage.Tan glistening pannus covers the sewing ring on the outflow a small amount of pannus extended from the sewing ring over to the carbon assembly.Thrombus / blood remnant residue was observed on the inflow and outflow surfaces of both leaflets as well as around the hinge mechanisms.An unknown amount of pannus appears to have been removed on the inflow and outflow during explant.Using a blue actuator to test leaflet movement, the leaflets appear to move without difficulty.Due to pannus, the carbon subassembly could not be rotated in the sewing ring.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Based on the analysis and investigation, the reported leaflet motion issue may have been caused by: thrombus build up in the pivots of the leaflets and impede their opening and closing pannus overgrowth over the sewing ring and into the orifice of the valve inhibiting leaflet motion.Reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient-related con dition.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: 7754084
• Report Number: 3008592544-2018-00025
• Device Sequence Number: 1567185
• Product Code: LWQ
• UDI-Device Identifier: 00613994960252
• UDI-Public: 00613994960252
• 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: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 07/08/2016
• Device Model Number: 500DM27
• Device Catalogue Number: 500DM27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 09/06/2018; 08/08/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 09/28/2018; 10/04/2018
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 74