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

Model Number 500

Device Problem Incomplete Coaptation (2507)

Patient Problem Corneal Pannus (1447)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: the hospital disposed of the product specimen.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.(b)(4).

Event Description

Medtronic received information that 14 years 9 months post implant of this mechanical valve, the physician observed that the opening angle of the valve was approximately 70 degrees.The physician reported that subvalvular pannus was observed and that pannus formation may be a cause of the decreased opening angle.No other adverse patient effects were reported.

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: 5332758
• MDR Text Key: 34610010
• Report Number: 3008592544-2015-00052
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2004
• Device Model Number: 500
• Device Catalogue Number: 500FA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided; 01/20/2016
• Supplement Dates FDA Received: 01/21/2016; 09/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/1999
• 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: 00073 YR