MAUDE Adverse Event Report: MEDTRONIC ATS MEDICAL OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 505DM22

Device Problems Sticking (1597); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 12/10/2013

Event Type  Injury  

Event Description

Medtronic received information that this mechanical heart valve was implanted as a replacement to another manufacturer's heart valve after the patient underwent an excision of a left ventricular aneurysm.After the patient was removed from bypass support, echocardiography showed that a leaflet was stuck.The patient was returned to a heart-lung machine, and the valve was rotated to resolve the issue with no adverse patient effects.The surgeon reported that the cause of the stuck leaflet was unknown but might have resulted from interference from a pericardial patch that was put on the excision site of the left ventricular aneurysm.The valve remains implanted.No patient information was provided.

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.The valve remains implanted.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 leaflet motion was related to a failure of the device to meet specification.Since the valve remains implanted after being rotated, it is likely that the pericardial patch (or possibly sub-valvular tissue) was the cause of the stuck leaflet.The open pivot instructions for use has the following caution when implanting mitral valves: ¿caution: if mitral valve apparatus preservation techniques are used, it is important to check leaflet motion following valve implantation.¿ should the product be explanted and returned, a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

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

• Brand Name: OPEN PIVOT AP360 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: 3556070
• MDR Text Key: 4219140
• Report Number: 2134151-2014-00003
• 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: 12/24/2013

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2020
• Device Model Number: 505DM22
• Device Catalogue Number: 505DM22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/24/2013
• Initial Date FDA Received: 01/06/2014
• Supplement Dates Manufacturer Received: 12/24/2013
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention