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

Model Number 505

Device Problem Material Disintegration (1177)

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

Event Date 06/28/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested, but no new information has been received to date.If additional information is received, a supplemental report will be submitted.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 during the implant of this mechanical valve, the valve leaflet broke into three pieces; the device was inspected prior to implant with no abnormalities noted.The valve was explanted and replaced.No other adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this mechanical valve was handled by its leaflets.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

Evaluation: the product was received loose in the inner packaging carton in the original product box.No valve holder was present.A section of one leaflet was received detached and broken.One leaflet remained intact.One leaflet appeared intact with no evidence of damage such as cracks or surface anomalies.A broken section of the other leaflet was received.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 intact 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.Conclusion: the device investigation is ongoing, and a conclusion is not yet available.

Manufacturer Narrative

Conclusion: attempts to obtain additional information regarding the instrument that was used to handle the device were unsuccessful.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.Based on the analysis and the limited reported information, the leaflet fracture may have been occurred during valve rotation.The user rotated the valve with the leaflet rather than using the rotator.

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: 5803888
• MDR Text Key: 49859064
• Report Number: 3008592544-2016-00044
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2020
• Device Model Number: 505
• Device Catalogue Number: 505DA22
• Device Lot Number: 718340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2015
• 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: 60 YR