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

Model Number 500DM29

Device Problems Structural Problem (2506); Incomplete Coaptation (2507); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2018

Event Type  Injury  

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 Description

Medtronic received information that immediately after implant of this mechanical valve, the valve was explanted due to one of the leaflets being stuck.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that after implanting this 29mm mechanical valve in the tricuspid position and closing the atrium, transesophageal echocardiogram (tee) identified one of the leaflets was not moving.The atrium was re-opened and valve explanted.The physician expanded the valve and did not see any impingement, anatomical or sub-valvular.A new 29mm mechanical valve was implanted successfully.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, both leaflets were in the closed position.Using a blue actuator to test leaflet movement, the leaflets moved without difficulty.Both leaflets were intact with no evidence of damage such as cracks and/or surface anomalies.Both inflow and outflow valve hinge mechanisms were intact.The carbon subassembly rotated normally 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.The valve was visually inspected with no anomalies noted.There were no as-manufactured surface finish anomalies identified.The cuff met specification and the serial number was verified to be correct.The valve leaflets were fully mobile.Based on the analysis, the complaint could not be confirmed as there was no evidence of a leaflet motion issue.A conclusive cause of the reported event could not be determined as the device met all manufacturing specifications.With the available information, a patient anatomy cause cannot be excluded.A patient information updated if information is provided in the future, a supplemental report will be issued.

• Brand Name: OPEN PIVOT MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): .; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 8154830
• MDR Text Key: 130038218
• Report Number: 3008592544-2018-00064
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2021
• Device Model Number: 500DM29
• Device Catalogue Number: 500DM29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 86