MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number FR995-21

Device Problem Gradient Increase (1270)

Patient Problems Corneal Pannus (1447); Death (1802)

Event Date 11/13/2014

Event Type  Death  

Manufacturer Narrative

Investigation results: 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.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Pannus overgrowth is an inherent risk of surgical valve replacement and can lead to high gradient measurements.Medtronic will continue to monitor field performance for similar events.Correction: the previous medwatch report noted a permanent pacemaker (ppm) was implanted.This information was incorrect; additional corrected i nformation noted a patient prosthesis mismatch (ppm) had occured.(b)(4).

Event Description

Medtronic received information that two years and ten months post implant of this bioprosthetic aortic root valve, the valve was explanted due to pannus ingrowth over the valve and the coronary orifice; high gradient measurements and permanent pacemaker implant were also noted.During the valve revision procedure, extended cross clamp time was required due to the left main coronary button tissue had disintegrated during the revision procedure.Another bioprosthetic aortic root valve and an annuloplasty mitral ring were implanted.It was reported that the patient subsequently expired one day post implant due to the extended procedure.

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.Reduced performance of the valve was reportedly attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.The product was not returned.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• 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: 4369639
• MDR Text Key: 18865473
• Report Number: 2025587-2014-01036
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2013
• Device Model Number: FR995-21
• Device Catalogue Number: FR995-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2015
• Date Device Manufactured: 04/20/2011
• 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): Death
• Patient Age: 00073 YR