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

Model Number 505DA

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

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

Event Date 03/21/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: product analysis and investigation are anticipated but have not yet been completed.

Event Description

Medtronic received information that immediately following implant of this mechanical valve in the pulmonary position, it was explanted and replaced due to leaflet jam.It was noted that the mechanical sizer was not set to the appropriate size during attempted implant, and a larger size was implanted.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen was visually examined.The valve was discolored showing evidence of blood contact.The existing leaflet was in the closed position.The leaflet appeared intact with no evidence of damage such as cracks and/or surface anomalies.Both inflow and outflow orifices and valve hinge mechanisms appeared intact with no evidence of damage.Using a blue actuator to test leaflet movement, the one leaflet 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.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.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, the physician indicated that the cause of this event was a sizing error.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen was visually examined.The valve was discolored, showing evidence of blood contact.The existing leaflet was in the closed position.The leaflet appeared to be intact with no evidence of damage such as cracks and/or surface anomalies.Both inflow and outflow orifices and valve hinge mechanisms appeared to be intact with no evidence of damage.Using a blue actuator to test leaflet movement, both 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.Conclusion: the device history record was reviewed.The valve was built to specification and met all inspection and acceptance criteria.A conclusive cause of the reported event could not be determined.Based on the analysis, the complaint could not be confirmed and there was no evidence of a leaflet motion issue.However, based on the received information, the physician indicated that the cause of this event was a sizing error.

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: 5586122
• MDR Text Key: 42938634
• Report Number: 3008592544-2016-00023
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2020
• Device Model Number: 505DA
• Device Catalogue Number: 505DA16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2015
• 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: 00006 MO