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

Model Number 501DM24

Device Problems Gradient Increase (1270); Incomplete Coaptation (2507)

Patient Problems Corneal Pannus (1447); Mitral Valve Stenosis (1965)

Event Date 05/15/2019

Event Type  Injury  

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 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
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8787640
• MDR Text Key: 150957928
• Report Number: 3008592544-2019-00030
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00613994960368
• UDI-Public: 00613994960368
• Combination Product (y/n): N
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2016
• Device Model Number: 501DM24
• Device Catalogue Number: 501DM24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 64