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

Model Number	500DM25
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
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 this 25mm mitral mechanical valve was implanted and explanted during the same procedure.The device was replaced with a 24mm mechanical valve for unknown reasons.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Correction submitted to clarify the event description: medtronic received additional information that this 25mm mitral mechanical valve was implanted and explanted during the same procedure.The reason for the replacement is due to the significant scar tissue on the ventricular side, which caused one of the leaflets to not move freely.As a result the valve was removed and successfully replaced with a 24mm mechanical valve.No additional adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Medtronic received information that this 25mm mitral mechanical valve was implanted and explanted during the same procedure.Due to the patients non medtronic bioprosthetic valve being stenosed, which caused this 25mm valve not to seat properly.As a result the valve was removed and successfully replaced with a 24mm mechanical valve.No additional adverse patient effects were reported.  updated device code.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: OPEN PIVOT MECHANICAL HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 8220646
• Report Number: 3008592544-2019-00001
• Device Sequence Number: 14113638
• Product Code: LWQ
• UDI-Device Identifier: 00643169335042
• UDI-Public: 00643169335042
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2019

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: 01/27/2021
• Device Model Number: 500DM25
• Device Catalogue Number: 500DM25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/24/2019; 02/15/2019
• Initial Report FDA Received Date: 01/06/2019
• Supplement Report FDA Received Date: 01/30/2019; 02/16/2019
• 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: 45 YR
• Patient Weight: 77