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

Model Number 501DA18

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/15/2014

Event Type  Injury  

Event Description

Medtronic received information that following implant of this aortic mechanical valve, the physician was unable to remove the patient from bypass.An echocardiogram revealed that the valve leaflet was not opening.The valve was explanted and replaced with a similar medtronic valve.No adverse patient effects were reported.The explanted valve will be returned for analysis.

Manufacturer Narrative

The product has not been returned for analysis, however, the return is anticipated.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the product be returned, a supplemental report will be filed following the completion of the analysis.(b)(4).

Manufacturer Narrative

Conclusion: the device history record of this valve was reviewed and no anomalies were noted that would have impacted this event.Without product return, a conclusive cause of the reported event could not be determined.It was reported that the surgeon had checked leaflet motion with the leaflet actuator following implant, and the leaflets moved properly during the check.

Event Description

Subsequently, it was reported that the surgeon had checked leaflet motion with the leaflet actuator following implant, and the leaflets moved properly during the check.The valve was replaced with another of the same size.

Manufacturer Narrative

Analysis: the device was received by medtronic plc loose in the original inner packaging tray in the original outer box.The valve holder was received with the valve.The sewing ring was discolored showing evidence of blood contact.The valve did not show evidence of impingement that may have contributed to leaflet motion.Both leaflets appeared intact with no evidence of damage.Both inflow and outflow valve hinge mechanisms appeared intact.The inflow and outflow orifices appeared intact with no evidence of damage.A blue actuator was used to test leaflet movement, and the leaflets appeared to move without difficulty.The valve was rinsed under tap water and it was verified that the carbon subassembly rotated in the sewing ring.The sewing ring was removed by systematically undoing the stitching to expose the stiffening ring window.The lock wire was pulled out and the stiffening ring removed from the orifice.The serial number was verified.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.Conclusion: no evidence of a leaflet motion issue was noted.Based on the analysis and the reported information, the complaint could not be confirmed.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis 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: 4248283
• MDR Text Key: 5018850
• Report Number: 3008592544-2014-00039
• 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: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2019
• Device Model Number: 501DA18
• Device Catalogue Number: 501DA18
• Device Lot Number: 666507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2014
• 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