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

Model Number 995

Device Problem Compatibility Problem (2960)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2014

Event Type  Injury  

Event Description

Medtronic received information that at approximately seven months and two weeks post-implant this bioprosthetic aortic valve was explanted due to a genetic sub-aortic membrane that was causing suture line dehiscence.In addition it was reported that the patient was medically non-compliant after the implant, a consistent cocaine abuser, and the patient had a very small root and partially obstructed left ventricular outflow tract (lvot).The valve was replaced with another bioprosthetic aortic valve.There were no performance allegations or further adverse patient effects reported.

Manufacturer Narrative

A review of the device history record (dhr) was performed for this valve, there were no non-conformances identified in manufacturing process (raw materials, manufacturing time period, or packaging and labeling) that could be related to this event.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.There were no alleged deficiencies related to product quality/performance or manufacturing process.Without the return of the valve, a root cause of the event was unable to be determined.(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: 4358251
• MDR Text Key: 18065048
• Report Number: 2025587-2014-01026
• 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
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2018
• Device Model Number: 995
• Device Catalogue Number: FR995-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2013
• 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: 00053 YR