MAUDE Adverse Event Report: MEDTRONIC ATS MEDICAL MITRAL AP MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 501DM16

Device Problem Incomplete Coaptation (2507)

Patient Problems Low Blood Pressure/ Hypotension (1914); Thrombus (2101); Respiratory Failure (2484)

Event Date 12/01/2013

Event Type  Injury  

Event Description

Medtronic received information that this mitral mechanical heart valve was explanted approximately four months after implant due to a stuck leaflet.Upon explant, thrombus was observed under a valve leaflet and in the leaflet hinge.It was reported by the surgeon that the thrombus was due to discontinuation of warfarin therapy, which was the result of the eleven-month-old patient having experienced an unrelated cerebral hemorrhage approximately two months after device implant.After the patient's condition was stabilized, the warfarin therapy was resumed with a prothrombin time/international normalized ratio of 1.2; however, the patient experienced respiratory failure and blood pressure reductions, and the stuck leaflet was observed.The valve was replaced with another medtronic valve with no adverse patient effects.

Manufacturer Narrative

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.It was reported the device is not available for return.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.However, there is no evidence to suggest that the cause of the thrombus was related to a failure of the device to meet specification.Although the valve was not returned for analysis to confirm the clinical observation, the cause of the stuck leaflet appears to be the reported thrombus, which was due to the lack of anticoagulant medicine.The instructions for use states: ¿the medical literature indicates that patients implanted with mechanical heart valves should be routinely maintained on anticoagulants to reduce the risk of valve thrombosis and thromboembolism.¿ (b)(4).

Manufacturer Narrative

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

• Brand Name: MITRAL AP MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC ATS MEDICAL; 3905 annapolis lane north; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3556051
• MDR Text Key: 16057137
• Report Number: 2134151-2014-00002
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 501DM16
• Device Catalogue Number: 501DM16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2013
• Was Device Evaluated by Manufacturer?: No
• 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: 00015 MO