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

Model Number FR995

Device Problem Material Separation (1562)

Patient Problems Aortic Insufficiency (1715); Fatigue (1849); Fever (1858)

Event Date 04/28/2015

Event Type  Injury  

Manufacturer Narrative

Conclusion: 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.Based on the risk analysis, the common potential causes for commissure dehiscence are calcification, pannus overgrowth and/or overworked commissure tissue.Without the return of the valve for analysis, the conclusive cause of the dehiscence cannot be determined.Based on the received information, the reported regurgitation is likely to be attributed to the commissure dehiscence.

Event Description

Medtronic received information that two years, three months post implant of this bioprosthetic valve, this valve was explanted and replaced with another medtronic bioprosthetic valve.Three weeks prior to this procedure, the patient reported feeling fatigue and had developed a new heart murmur.The patient had presented at the hospital with chills and a low-grade temperature, and acute aortic insufficiency; a transesophageal echocardiogram (tee) was performed showing clear aortic valve leaflet, with no evidence of a paravalvular abscess.Upon explant, it was noted that there was no vegetation, but the commissure between the right and left coronary leaflets had pulled away from the rest of the porcine aorta and porcine tissue graft.No other adverse patient effects were reported.

Manufacturer Narrative

The device has not been returned for analysis.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

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

• 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: 4821828
• MDR Text Key: 13700916
• Report Number: 2025587-2015-00625
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2017
• Device Model Number: FR995
• Device Catalogue Number: FR995-27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2012
• 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: 00068 YR