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

Model Number	501DM24
Medical Device Problem Codes	Gradient Increase (1270); Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Corneal Pannus (1447); Mitral Valve Stenosis (1965)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: no product was returned.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 4 years 11 months post implant of this 24mm mitral mechanical valve, it was explanted and replaced with a 27mm mitral bioprosthetic valve.The valve was replaced due to pannus formation which was reported to cause severe stenosis of the prosthetic valve.Additionally, it was noted that the posterior leaflet was fixed and a 14mmhg gradient was present.No additional adverse patient effects were reported. .

• Brand Name: MITRAL AP MECHANICAL HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 8787640
• Report Number: 3008592544-2019-00030
• Device Sequence Number: 1998769
• Product Code: LWQ
• UDI-Device Identifier: 00613994960368
• UDI-Public: 00613994960368
• Combination Product (Y/N): N
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2019

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: 10/14/2016
• Device Model Number: 501DM24
• Device Catalogue Number: 501DM24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/14/2019
• 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: 77 YR
• Patient Weight: 64