MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 505DM24

Device Problems Inadequacy of Device Shape and/or Size (1583); Incomplete Coaptation (2507)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/11/2018

Event Type  Injury  

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 Description

Medtronic received information that immediately post implant of this mitral mechanical valve in a patient with severe calcification, the leaflets would not open and close as expected.The valve was explanted and replaced.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the valve was replaced with another 24mm mechanical valve of the same model.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic received additional information that after implanting this 24mm mechanical valve, the patient's chordae tendinae became shortened, thickened and adhered together.The surgeon indicated the valve leaflets were blocked by the chordae tendinae and that the reason for explant was patient prosthesis mismatch due to the valve not matching the patient's native annulus, and thickened chordae tendinae preventing the leaflets from opening properly.The valve was replaced with another mechanical valve.During the initial implant, the native tissue was partially resected and partially retained.No additional adverse patient effects were reported.  patient weight added.Patient and device codes updated.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 AP360 HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 8241583
• MDR Text Key: 132854385
• Report Number: 3008592544-2019-00002
• Device Sequence Number: 1
• Product Code: LWQ
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2022
• Device Model Number: 505DM24
• Device Catalogue Number: 505DM24
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 76