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

Model Number FR995

Device Problems Gradient Increase (1270); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Thrombus (2101); Blood Loss (2597)

Event Date 12/20/2015

Event Type  Death  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Multiple attempts have been made to obtain additional information without success at this time.If additional information is received, a supplemental report will be submitted.(b)(4).

Event Description

Medtronic received information from this patient's daughter that approximately two months post implant of this bioprosthetic aortic valve, the patient had expired from a stroke and that there were clots forming on the valve.It was not reported whether the death was device related.No autopsy report has been received.

Manufacturer Narrative

Medtronic received additional information from this patient's physician that the cause of death was multiple strokes, apparently from thrombus originating on this bioprosthetic valve.Echocardiogram showed increased gradient and thrombus.Multiple cultures were all returned negative.Thrombocytopenia (tcp) occurred from apparent consumptive process due to valve thromboses; the thrombocytopenia resulted in propensity for bleeding and blood loss.The patient expired from central nervious system (cns) events due to clots on valve.It was noted that the patient was given 81 mg acetylsalicylic acid (asa) postoperatively.No autopsy was performed.

Manufacturer Narrative

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.

• 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 HEART VALVES DIVISION; 1851 e deere ave; santa ana CA
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5529414
• MDR Text Key: 41266602
• Report Number: 2025587-2016-00358
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2020
• Device Model Number: FR995
• Device Catalogue Number: FR995-27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2015
• 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: 00067 YR