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

Model Number 500FA23

Device Problem Perivalvular Leak (1457)

Patient Problem Endocarditis (1834)

Event Date 11/17/2014

Event Type  Injury  

Event Description

Medtronic received information that approximately 16 months post-implant, this mechanical heart valve was explanted due to a paraval vular leak caused by weakened tissue from infective endocarditis.It was reported that the neither the pvl nor the endocarditis were caused by the valve, and that the leaflet of the explanted valve operated normally.Another medtronic mechanical heart valve was im planted.No adverse patient effects were reported.

Manufacturer Narrative

It was reported that the explanted valve would not be returned.(b)(4).

Manufacturer Narrative

The reported information did not indicate a potential manufacturing issue.From the available information, the valve was explanted due to paravalvular leak (pvl) caused by weakened tissue from the patient¿s infective endocarditis.It was reported that the neither the pvl nor the endocarditis were caused by the valve, and that the leaflet of the explanted valve moved smoothly without issue.

Manufacturer Narrative

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

• Brand Name: AORTIC FLEX
• 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: 4318175
• MDR Text Key: 5130118
• Report Number: 3008592544-2014-00041
• 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,Followup
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500FA23
• Device Catalogue Number: 500FA23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2015
• 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: 00041 YR