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

Model Number 501

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Left Ventricular Dysfunction (1947)

Event Date 04/06/2016

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.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.

Event Description

Medtronic received information that immediately following implant of this mechanical valve, it was explanted and replaced due to leaflet motion and severe left ventricular dysfunction (lvd).No other adverse patient effects were reported.

Manufacturer Narrative

Additional information was received indicating the size of the valve was too large; therefore, a smaller valve was implanted.It was also noted the patient was symptomatic with hypertension.No other adverse patient effects were reported.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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product sample was visually examined.The valve did not show evidence of impingement that may have contributed to leaflet motion.The valve appeared intact with no evidence of damage such as cracks, breaks and/or surface anomalies.The valve tissue annulus diameter was verified and met specification.After cleaning, both leaflets opened and closed without difficulty.The assembly was moved back and forth to show the leaflets moved without difficulty.Both leaflets appeared intact with no evidence of damage such as cracks and/or surface anomalies.Both inflow and outflow valve hinge mechanisms appeared intact.The inflow and outflow orifices appeared intact with no evidence of damage.Using a blue actuator to test leaflet movement, 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 ex pose the stiffening ring window.The lock wire was pulled out and the stiffening ring removed from the orifice.The serial number was verified.Conclusion: a review of the device history record (dhr) was performed for this valve; there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.A conclusive cause of the reported event could not be determined.Based on the analysis, the complaint could not be confirmed and no evidence of a leaflet motion issue was noted.However, based on the received information, a smaller size medtronic valve was implanted; it could be potentially suggested that sizing could be the cause of the leaflet motion issue.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.

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, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6034002
• MDR Text Key: 57632782
• Report Number: 3008592544-2016-00056
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2019
• Device Model Number: 501
• Device Catalogue Number: 501DA20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/13/2017
• Supplement Dates FDA Received: 10/27/2016; 04/20/2017; 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2014
• 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
• Patient Age: 38 YR