MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 505DA

Device Problems Gradient Increase (1270); Incomplete Coaptation (2507); Device Operates Differently Than Expected (2913)

Patient Problems Host-Tissue Reaction (1297); Aortic Valve Stenosis (1717)

Event Date 09/09/2005

Event Type  Injury  

Event Description

Medtronic received information that a (b)(6) female patient with a history of bicuspid aortic valve stenosis underwent successful implant of a medtronic advancing the standard (ats) 21-mm open-pivot mechanical heart valve (serial not reported).Postoperatively, the patient was asymptomatic and free of complications.Three years post-implant echocardiography showed a new cardiac murmur, high transvalvular pressure gradient, and a reduction in the valve orifice area.Cineradiography revealed restricted leaflet opening.Computed tomography demonstrated pannus overgrowth on the inflow aspect of the valve, and also dark spots of attenuation in the periannular region, suspected to be either degenerated sewing cuffs or pledgets used for valve fixation.In surgery, excessive growth of pannus over the valve-housing ring of the inflow side of the valve was confirmed, resultant in subvalvular stenosis and narrowing of the valve orifice area.The valve was explanted and successfully replaced by a non-medtronic bioprosthetic valve.No additional adverse patient effects were reported.

Manufacturer Narrative

The device was not returned to medtronic.(b)(4).

Manufacturer Narrative

Requests for additional information provided no further details.Conclusion: no device was returned and no unique device identifier numbers were provided.Based on the available information, a review of the device history record could not be performed and root cause could not be identified.

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, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4836181
• MDR Text Key: 5940609
• Report Number: 3008592544-2015-00018
• 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,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 505DA
• Device Catalogue Number: 505DA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2015
• 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: 00064 YR