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

Model Number 500

Device Problem Sticking (1597)

Patient Problem Syncope (1610)

Event Date 01/15/2014

Event Type  Injury  

Manufacturer Narrative

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.A conclusive cause of the reported event could not be determined as the device met specification and the complaint could not be confirmed during the analysis of the returned valve.A formal investigation has been initiated to investigate similar field complaints.Medtronic will continue to monitor for similar events.

Manufacturer Narrative

Product analysis: no additional information received.Analysis completed, complaint not confirmed.Upon receipt at medtronic¿s quality laboratory, the valve was visually inspected with no anomalies noted.The serial number was verified to be correct.The valve leaflets were fully mobile.The valve was inspected and functionally tested per manufacturing procedure and met specifications.The carbon components and stiffening ring were dimensionally inspected and met engineering specifications.Investigation is still in progress, once the investigation and device history review is complete a supplemental report will be submitted.

Event Description

Medtronic received information that 26 days post implant of this 27mm mechanical mitral valve, the patient collapsed, and on examination a stuck leaflet was discovered.An emergency re-operation was performed where clots in the valve were found.After clearing the clots, the leaflet was able to close, however after coming off bypass one leaflet again would not move properly.This valve was explanted and a new 25mm medtronic mechanical valve was implanted.No adverse patient effects were reported during the replacement procedure.

Manufacturer Narrative

The device return has been requested, however, the product has not been received.This event will be updated should the product be returned and analysis completed.(b)(6).(b)(4).

• Brand Name: OPEN PIVOT MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC ATS, INC.; 3905 annapolis lane, suite 105; plymouth MN 55447
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3624634
• MDR Text Key: 12105022
• Report Number: 2134151-2014-00004
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500
• Device Catalogue Number: 500DM27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00059 YR