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

Model Number 500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Corneal Pannus (1447)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

The patient's weight has been requested; however, it remains unknown.Product analysis: the product has not been returned for analysis, however, the return is anticipated.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 1 year and 5 months post implant of this mechanical valve, it was explanted and replaced due to pannus formation.No further adverse patient effects were reported.

Manufacturer Narrative

Analysis: the valve was received by medtronic plc in a specimen container without solution.Green and white multifilament sutures remained attached to the sewing ring on the inflow and outflow sides of the valve.The leaflets were in the closed position.The leaflets appeared intact with no evidence of damage such.Both inflow and outflow valve hinge mechanisms appeared intact.The inflow and outflow orifices appeared intact with no evidence of damage.Tan glistening pannus covered the sewing ring on the inflow and outflow sides of the valve, extending slightly over the orifice on the inflow and leaflets.Radiography showed no evidence of mineralization in the valve or host tissue.Conclusion: the analysis results of the device showed pannus covered the sewing ring on the inflow and outflow extending slightly over the orifice on the inflow and leaflets which could have restricted the leaflets' motion.Pannus overgrowth has been an inherent risk of surgical valve replacement and is associated with surgical valve replacement due to patient interaction and/or healing response with the surgical valve.The clinical observation was confirmed.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: OPEN PIVOT MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5624098
• MDR Text Key: 44156997
• Report Number: 3008592544-2016-00028
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2019
• Device Model Number: 500
• Device Catalogue Number: 500DM29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2014
• 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: 65 YR